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Covid-19 Vaccines and Medicines

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Part of the Economic and Financial Law & Policy – Shifting Insights & Values book series (EFLP,volume 7)

Abstract

Chapter 9, entitled “Covid-19 Vaccines and Medicines” of the book entitled “Covid-19 and Capitalism - Success and Failure of the Legal Methods for Dealing with a Pandemic”, deals with the search for vaccines and medicines to combat the Covid-19 virus. Methodologically, as has been the case for the other chapters of this book, this chapter as well relies to a substantial extent on research evidence and factual research provided by an amalgam of policy institutions, academic researchers—working in the medical or other fields—and specialized investigative journalists. The importance of this factual research cannot be sufficiently emphasized. In this chapter, therefore, the findings of these institutions and authors have each been meticulously synthesized, with explicit acknowledgment that the institutions and authors cited have, in many cases, been the original authors of the relevant positions and opinions thus cited. This chapter especially offers an assessment of the success and failure of some of the capitalist working methods in the fight against a pandemic, showing that a wide variety of said capitalist working methods have in many cases been pernicious to the deployment of the results of scientific research in the form of tangible vaccines and medicines. This chapter also illustrates the folly of various neoliberal policies. Perhaps the main follies committed in the EU concern the way the Covid-19 vaccines were procured, resulting in a disastrous start of the EU member states’ vaccination campaigns during Q1 2021 and the month of April 2021. The follies committed in the U.S. are more subtle and rather concern the influencing of the minds of a large part of the American population who, brainwashed by the writings of Ayn Rand and consorts into a false idea of freedom, continue to this very day to demonstrate a reluctance against being vaccinated (as well as against face masks), which greatly complicates the way out of the pandemic. This chapter of the book concludes with a call for a different organization of the socioeconomic order, especially in terms of the organization of the pharmaceutical sector, as well as the health sector in a more general sense.

9.1 General

Already in 2020, at an early stage of the Covid-19 outbreak, vaccination started to be perceived as the most effective long-term strategy for prevention and control of Covid-19.Footnote 1

Because of this, a variety of vaccine platforms against Covid-19 started being developed, including: (1) recombinant vectors; (2) DNA/mRNA in lipid nanoparticles; (3) inactivated viruses; (4) live attenuated viruses, and (5) protein subunits.Footnote 2 According to Hu, Ghuo and Zhou, early October 2020, 174 vaccine candidates for Covid-19 were in the running, and 51 of these were in the phase of human clinical trials. Many of these vaccine in development had reached the phase II testing phase, with some even already advanced to phase III trials. A lot of the Covid-19 vaccines showed a low rate of adverse reactions and effectively caused antibody production neutralizing the Covid-19 virus.Footnote 3

By 24 March 2021, the number of vaccines was up to 204 in total, of which 122 in preclinical development and 80 in the phase of human trials.Footnote 4

However, throughout the Covid-19 pandemic, science has been persistently looking not only for Covid-19 vaccines, but also for (classic) drugs to treat Covid-19. This research focused both on the potential usefulness of existing drugs (initially developed for other diseases), and on inventing new drugs with a view to the specific treatment of Covid-19. By 24 March 2021, 498 therapeutic drugs for treating Covid-19 were in development, of which 411 were in the phase of human trials and 87 in preclinical development.Footnote 5

9.2 Free Market Organization

9.2.1 General: Impact of the Pursuit of Profits as Leading Societal Principle

The search for vaccines and medicines, obviously, had to take place in the context of the prevailing, predominant socioeconomic system on earth, namely “capitalism”. This has led to serious, ethical questions in relation to medicine development for decades already in the past. Regretfully, the search for vaccines and drugs to combat the Covid-19 pandemic would make these questions more relevant than ever.

Under capitalism, there is but one value that governs economic functioning in general, and that of enterprises more in particular. It is the (unbridled) pursuit of profits-principle (instead of, e.g., the general wellbeing of humanity and the Earth it inhabits). This applies not only to pharmaceutical enterprises which produce vaccines and drugs, but also, as we have discussed in Chaps. 5 and 6, to an ever-growing extent, hospitals and long-term nursing homes.Footnote 6

According to Galbraith, the presentation of self-interest as the most important motivating economic force has been one of the most serviceable means to advocate entrepreneurial power. No other means of justifying capitalist behaviour has served for so long. Thanks to this approach, entrepreneurs do not need to make any effort to explain their selfish motives. On the contrary, virtue is—by definition—given to any of their actions, by an overriding law of economics to which they are wholly subject (just as all other economic agents), however selfish, sordid or inspired by personal greed their motivations and purposes are.Footnote 7

As we shall explore in more detail in this chapter, even the worst health crisis in more than 100 years would fail to put this pursuit of profits on hold, as a result of which scientific efforts to bring the Covid-19 pandemic under control were severely affected by the pharmaceutical companies’ own agendas to turn even the most dreadful pandemic, with all pertaining human suffering, in yet another source of ever more profits.

9.2.2 Free Market Organized Research and Innovation

By adherents of capitalism in general, and of neoliberal thinking in particular, it is often—albeit mistakenly—held that all scientific, technological and medical progress in the world happens thanks to capitalism, in the case of medical progress, thanks to the efforts of the private, pharmaceutical sector. However, this proposition can be largely disproved with various arguments, including, in particular, the fact that most scientific progress is primarily due to the efforts of (individual) scientists—as a rule individuals with a passion for their research, for whom the pursuit of profit is by no means a determining factor.Footnote 8 Moreover, on a more institutional level, scientific research is, to a very large extent, carried out in non-profit institutions, such as universities (often—in total or in part—financed with public funds), next to a wide variety of other, specialized public institutions, including even institutions such as NASA and sections of armies. In other cases, research taking place in private institutions is still subsidized by governments, while often such private institutions work closely together with their public counterparts, e.g., universities, in which case their combined research activities are still mainly financed by means of public funding. What, by contrast, the private, entrepreneurial sector is good at, is to embrace the fruits of such scientific research, to monopolize them, and to commercialize or convert them into practical applications.

In the Covid-19 vaccine debate, this discussion has become, once again, very acute.

In March 2021, during a private call with Conservative MPs, UK PM Boris Johnson, literally, proclaimed that the UK’s at the time successful vaccine campaign was thanks to “greed” and “capitalism”. This fact was confirmed to the press by several of those present during an end-of-term Zoom meeting between Johnson and backbenchers of the Tory party, also referred to as the “1922 Committee”, which took place on Tuesday evening, March 23, 2021, and during which Johnson proclaimed that more than 28 million people in the United Kingdom had already been given a first jab of a Covid-19 vaccine, in best neoliberal traditions saying:Footnote 9

The reason we have the vaccine success is because of capitalism, because of greed my friends.

According to academic researcher Mariana Mazzucato—author of the book ‘The entrepreneurial state—Debunking public vs private sector myths’—if Johnson’s words provided any insight in his vision for how the United Kingdom was to find its way out the Covid-19 pandemic, the statement especially posed worrying implications for the United Kingdom’s national and foreign policies—and, by extension, for the policies of neoliberal governments all over the planet in general. The reason for this is that PM Boris Johnsons’s remark made a direct link to one of the credo’s that has been determinant for neoliberal, public policy as of the 1980s,Footnote 10 with all of its disastrous effects. According to Mazzucato, this was, moreover, not the first time that Johnson had drawn the wrong conclusions from the Covid-19 crisis. A few months before, Johnson had in a similar sense said that for “those on the left, who think everything can be funded by uncle sugar the taxpayer (…) there comes a moment when the state must stand back and let the private sector get on with it”. Nor was Johnson the first neoliberal politician having proclaimed the Covid-19 vaccines as an accomplishment for which the private sector deserved all credit.Footnote 11

According to Mazzucato, it is, e.g., worth remembering that the “AstraZeneca” vaccine was created by scientists at the University of Oxford, to be later on developed and distributed by the pharmaceutical giant “AstraZeneca” who (as happens often) emerged as one of victors in the public celebration of Covid-19 vaccines.Footnote 12 In a similar manner has the development of the mRNA-technology on which the Covid-19 vaccines of Pfizer-BioNTech and of Moderna were based, mainly been the accomplishment of a very few academic researchers, most notably Dr Katalin Kariko.Footnote 13

Moreover, an unprecedented amount of public funding had been poured into the Covid-19 vaccine research, development and manufacturing. In 2020, the leading six vaccine candidates in the field of vaccine development together had received an estimated USD 12 billion (£8.7 billion) of taxpayer and public money for doing their research, including USD 1.7 billion for the Oxford-AstraZeneca jab, and USD 2.5 billion for the Pfizer-BioNTech candidate.Footnote 14 Still according to Mazzucato, public funds spent on research and development are, in general, often more important than the research that is financed by the private sector itself—in the sense that governments often invest in the early, both longest and riskiest stages of (health) innovation, before any market is viable. Usually, the private sector is simply not interested in research and development at these early stages, as this costs too much money and does not result in short-time profits, and only jumps aboard when a clear opportunity for profit-making presents itself (i.e., when the medicines or vaccines or as good as ready for commercialization).Footnote 15

Obviously, this debate has all to do with the mythological world view that has been propagated by neoliberal doctrine as of the 1970s, esp. the idea that all societal progress happens thanks to the efforts of a few entrepreneurial geniuses to whom the rest of mankind should but be extremely grateful.Footnote 16 (Cf. Sect. 2.1) In her book “The Entrepreneurial State,” Mazzucato has analysed the impact of this neoliberal mythical world view on the private sector as a (wrongfully) presumed driver of innovation. Mazzucato found out that the purportedly most innovative enterprises are precisely those that have benefited the most from various types of direct public investment. In many cases, so-called venture capitalists even admit that they only went into a business after the state had done the heavy lifting in research and development. From research in the United States, it even appeared that, in the past decades, it has been the US (federal) government that has been taking the lead in innovation in a wide range of industries. Of the 88 most important innovations between 1971 and 2006, 77 had been entirely dependent on US federal support. More specifically, with regard to the private, pharmaceutical sector, the majority (75%) of new drugs came from publicly funded labs (at universities or other). From said research, it also appears that the private pharmaceutical industry itself only invests in research on less risky variations of existing drugs, once the groundwork has been done by the public sector. Yet, in order to justify its patent-based commercialization strategies with regard to these inventions, the sector—and with it numerous neoliberal academics—keeps doing everything in its power for upholding the myth that it is itself extremely innovative, while it is in reality mainly public laboratories that deserve this label.Footnote 17

Also in other innovative sectors such as informatics, biotechnology, nanotechnology, etc., states are the ones taking the lead in research with regard to radical (risky) innovation. Industry only starts to invest in developing products that are cost competitive with a time horizon of 3 to 5 years. Focusing on the short term—which is one of the basic dictates of capitalism (cf. Sects. 2.1 and 2.2)—often simply makes it unprofitable for private enterprises to invest in innovation at early development stages. Phrased differently, “patient investment” basically requires public financing and state development financing. As a result, at the foundations of extremely profitable and purportedly innovative private enterprises lie often huge state investments which, however, remain unrewarded once a private enterprise comes in play to commercialize the fruits of the government funded research. In such cases, it is basically citizens who have paid for innovative development through taxes, although they do not share in the financial profits derived from this. In the meantime, neoliberal propaganda still makes people believe that all economic growth and progress comes from entrepreneurial geniuses, and that there can only be such progress and growth by leaving everything to the private sector (usually referred to as “leaving everything in the hands of the free market”). By collectively continuing to believe in these myths of neoliberalism—with regard to research and development, but also with regard to numerous other domains of socioeconomic lifeFootnote 18–, we have thus ended up with a system in which the economy “socializes costs” through state investments, hence through tax money paid by ordinary citizens, but “privatizes the rewards” thereof, to the extent that private enterprises—hence, ultimately the shareholders of these—are the only ones profiteering from the fruits of such research. According to Foulon, a consequence of this system has been that entrepreneurial elites continue to enrich themselves at the expense of everyone else. Moreover, the large multinational corporations, which are the ones commercializing the scientific output of such publicly funded research, in most cases, hardly pay any taxes themselves, which would allow the state to, at least in this manner, receive some return on its investment, not only to pay for future innovations, but also to allocate more resources to education, healthcare and other important public services—which are, after all, among the true societal drives of scientific innovation.Footnote 19

Also with regard to the development of the Covid-19 vaccines, the pre-existing, government funded vaccination research, has been the main reason why pharmaceutical enterprises have been able to develop a Covid-19 vaccine in record time. (Cf. Sect. 9.3) As, by means of a further illustration, a report from the UK’s Industrial Strategy Council of March 2021 made clear, the fast turnaround of Covid-19 vaccines would have been unthinkable without state involvement and funding of vaccination research in at least the preceding decade.Footnote 20

As said report stated itself:Footnote 21

The Ox/AZ vaccine serves as a useful case study to help surface lessons from the wider programme under the auspices of the Vaccines Taskforce (VTF). Although it was one of many vaccines procured by the Government, development of the Ox/AZ vaccine took place mostly in the UK and so provides a window into how the Government influenced each stage of the process. Consequently, the paper does not provide a definitive account of the vaccine procurement programme. Deployment of Covid-19 vaccines is also out of scope, as it is ongoing at the time of publication.

We find that government played a key role in expediting every stage of the Ox/AZ vaccine development process.

(…)

The UK Government’s Covid-19 vaccine procurement programme is heralded as a flagship success of its response to the pandemic, securing a timely supply of vaccines for the UK population. It is also a natural experiment in the type of ‘mission- orientated’ industrial policy the Government has trailed in recent years. The public sector had a hand in every aspect of expediting the development of new vaccines, from the pre-pandemic discovery phase and clinical trials to emergency procedures in support of regulatory approval and building capacity for large-scale manufacturing.

By mid-April 2021, it was according to some sources clear that at least 97% of the financing for the development of the Oxford-AstraZeneca Covid-19 vaccine had originated from taxpayers’ or charities’ money. This had, more precisely, appeared form research referred to by Safi that had been conducted in an attempt to reconstruct where the money had come from for the funding of decades of scientific research that had ultimately resulted in the Oxford-AstraZeneca vaccine. Using a variety of research methods, the researchers were able to identify the source of hundreds of millions of pounds in research grants since 2000. The research had attempted to take all relevant research into consideration, starting with published academic work that lay at the roots of what would ultimately become the new technology behind the Oxford-AstraZeneca vaccine, as well as research with regard to the final stages of the product development itself. Form this research, it appeared that the overwhelming majority of the funding, especially in the early stages of research, had stemmed from UK government departments, UK and US scientific institutes, the European Commission and charities, such as, e.g., the Welcome Trust. Less than 2% of the funds identified by the referred to researchers originated from the private sector. This obviously challenged the views of adherents of economic neoliberalism, such as UK Prime Minister Boris Johnson himself.Footnote 22

Phrased differently, and in stark contrast to UK Prime Minister Johnson’s earlier statement: In the case of the Covid-19 vaccines, it had mainly been effective and mission-oriented government coordination—from the development of industrial policy, to investment in academic sciences, as well as in strategic long-term public programmes and public-private partnerships—that had been key to the rapid development of the Covid-19 vaccines.Footnote 23 After which, as with most inventions that conform to the logic of neoliberal capitalism, the manufacture and distribution of Covid-19 vaccines would be left entirely to the free market, allowing free market players to reap the fruits of decades of public investment.Footnote 24 This seems to imply that, also with regard to the vaccine market, the neoliberal principle of “socialising costs and privatising profits” fully applies.

Similarly, in the United States, it is mainly federal institutions, such as “BARDA” (short for “Biomedical Advanced Research and Development Authority”), “DARPA” (short for “Defense Advanced Research Projects Agency”), “NIH” (short for “National Institutes of Health”) and “NSF” (short for “National Science Foundation”), that are pushing the frontiers of research and innovation and that enable scientific progress in many sectors, of which the private sector ultimately bears the fruits.Footnote 25 With regard to innovation outputs, over the period 2010–2017, the United States had, e.g., been far ahead of Germany, France, and the Scandinavian countries in terms of the number of patents per million inhabitants. The dominant position of the United States in this regard was even more striking when only taking the top 5% patents into consideration.Footnote 26 Table 9.1 gives a general overview of the average annual numbers of patents in 2010–2017.

Table 9.1 Annual average patents 2010–2017a

Another method for measuring the innovation output between countries or regions consists of measuring the global value-added output of R&D intensive industries. Over the period 2003-2018, the EU was said to account for about 20–22%, on average, of the global VA in R&D intensive sectors, which was far less than its average share of world GDP (which during said period, on average, accounted to 26%). By contrast, during said time period, the United States accounted, on average, for about 30% of the VA of R&D intensive sectors, while its average share in the world GDP only amounted to 24%.Footnote 27

Pharmaceutical enterprises, supported by neoliberal governments and their legislators all around the world, often insist that there is no alternative to the dominant business model of “socialisation of costs and privatisation of profits”. The arguments against opening up the rights to manufacture Covid-19 vaccines have, in this regard, been exactly the same ones that the pharmaceutical industry has always resorted to—and that have been taught in introductory courses on intellectual property rights around the world as of the 1980s onwards—namely that it would endanger research and innovation, and that transferring the know-how for actual product development to others would be too complex, or simply not work.Footnote 28

But, as Buranyi rightly pointed out, the Covid-19 vaccines were developed because of huge amounts of public funding and research. In addition, generic manufacturers of drugs and vaccines operating in developing countries have proven again and again that they are indeed capable of producing large quantities of high quality drugs and vaccines at a fraction of the cost of what is paid for in Western countries. Finally, contrary to what neoliberals make people believe, the patent system allowing private enterprise to monopolise and commercialize drugs and vaccines created by public funding and research, even in the event of a global catastrophe, is but a recent invention that has been deliberately established under neoliberal doctrine itself. By contrast, during World War II, the federal US government had still been capable and willing to force pharmaceutical enterprises to share their antibiotic development methods and recipes. Similarly, during the global campaign against smallpox of a couple of decades ago, the WHO had kept a precise record of all manufacturing methods and recipes. This had allowed the WHO to constantly monitor and evaluate the progress made and to share the technology on a global scale. In the past, it has on numerous cases been recognised, in a collective manner, that there are things, such as international public health, that are more important than the legal protection of private profits. According to Buranyi, before the WTO and what this author refers to as “the proliferation of neo-liberal trade treaties”, countries around the world had regularly resorted to subjecting the pharmaceutical industry to “compulsory licensing” (or the at the time equivalent legal method) which allowed third-party, often local manufacturers to produce drugs or vaccines after paying a reasonable licence fee. This practice has in the past been so uncontroversial that Canada has even used it for anti-ulcer drugs. In summary, patents—and hence the legal monopoly of commercializing the proceeds of scientific research—have not always been as sacrosanct as they are in modern-day, neoliberal societies.Footnote 29 We shall return to these policy issues in the conclusions of this chapter. (Cf. Sect. 9.6.)

9.2.3 A First Idea of the Real Benefits

9.2.3.1 Introduction

While the advent of Covid-19 vaccines promised a quick return to a more normal life, it also led to the creation of a global Covid-19 vaccine market worth tens of billions of dollars in annual turnover for a small number of pharmaceutical enterprises that each monopolized its own vaccine.Footnote 30

At the beginning of 2021, among the biggest winners of the race for making a Covid-19 vaccine ready for use (and, hence, for commercializing it) were “Moderna” and “Pfizer” (the latter working together with “BioNTech”)—two very different US pharmaceutical enterprises, both of which started charging more than USD 30 per person for their two-shots vaccines. While Moderna had only been founded in 2010, had never made any profits before the Covid-19 crisis and had only employed a mere 830 people before the outbreak of the Covid-19 pandemic, Pfizer, whose roots go back to 1849, had already been making a net profit of USD 9.6 billion with regard to 2020 and was already employing nearly 80,000 people.Footnote 31 According to Kollowe, other drugmakers, such as the UK’s (and Swedish) AstraZeneca and the US’s Johnson & Johnson, had purportedly pledged to supply their Covid-19 vaccines on a not-for-profit basis until the Covid-19 pandemic would have ended.Footnote 32

Also according to Kollewe, whether the Covid-19 market will continue to remain a source of big money in the future was still unclear in early-2021 but remained dependent on the question whether the Covid-19 vaccines would require only a single injection in a human’s life—as, e.g., the vaccine for measles—or whether regularly administered subsequent jabs will be necessary, as, e.g., for influenza (cf. Sect. 9.3.1). But even regardless of the ultimate answer to this question, until every citizen of the world is vaccinated at least once against Covid-19, the financial stakes for monopolising an effective Covid-19 vaccine are extremely high.Footnote 33

Kollewe has made a first estimate of the revenues of some of the Covid-19 vaccines for the year 2021, and beyond. Based on the information she provided, hereafter follows an overview of these figures for the four most widely used vaccines in the first months of 2021 during the vaccination campaigns in the United States, the United Kingdom and the EU Member States, namely: (1) the “Comirnaty” vaccine (i.e., the commercial name for the Pfizer-BioNTech vaccine); next to (2) the Moderna vaccine; (3) the Johnson & Johnson vaccine and (4) the Oxford-AstraZeneca vaccine (which, in March 2021, had changed its product name into “Vaxzevria”, this name change having been approved by the EMA on 25 March 2021Footnote 34).

On 22 April 2021, the People’s Vaccine Alliance (abbreviated as “PVA”), furthermore, reported that three of the leading Covid-19 vaccine manufacturers—Pfizer-BioNTech, Johnsons & Johnson and AstraZeneca—had in 2020 together paid out USD 26bn in dividends and stock buyouts to shareholders—enough to cover the cost of vaccinating the entire population of Africa.Footnote 35

9.2.3.2 Pfizer and BioNTech

Pfizer’s Comirnaty vaccine that has been developed in cooperation with the German company BioNTech (the latter believed to be the main developer of the vaccine), is based on so-called “redesigned messenger RNA”—RNA being the molecule in cells that transmits the genetic instructions with regard to cell-making from the cell’s DNA to the protein-making machinery of a cell. The Pfizer-BioNTEch vaccine was the first Covid-19 vaccine and the first mRNA based vaccine to be approved for use on humans, its main disadvantage being that it had to be stored at ultra-low temperatures (−70 °C) (cf. Sect. 9.3.1.3). As of 6 March 2021, governments around the world had ordered approximately 780 million doses of the vaccine, including the United States (at the time good for 200 million doses, worth USD 3.9 billion) and the European Commission (good for 300 million doses), while a mere 40 million doses had been reserved for low-income nations through the Covax initiative. On 6 March 2021, the cost of the vaccine amounted to USD 39 for two doses in the United States and—due to the way the EU had been conducting the purchase negotiations; cf., furthermore, Sect. 9.4—to about USD 30 in the EU. Projected sales with regard to 2021 amounted to between USD 15 and 30 billion.Footnote 36

Pfizer, which shares costs and profit margins equally with BioNTech, expected to earn USD 15 billion from sales in 2021, based on contracts signed by early March 2021. However, the final figure for 2021 could be twice as high, as Pfizer had estimated that it could potentially supply 2 billion doses in 2021. At the beginning of March 2021, Barclays forecasted sales of USD 21.5 billion with regard to 2021, USD 8.6 billion with regard to 2022 and USD 1.95 billion with regard to 2023, assuming the vaccine would be given in a single dose.Footnote 37

Pfizer’s share prices over the period March 2020–March 2021 increased by 1.8%, and those of BioNTech even by 156%.Footnote 38 BioNTech’s two founders, husband and wife team Ugur Sahin and Özlem TüreciFootnote 39—both doctors—had become multibillionaires overnight in the course of 2020, when the vaccine’s potential and the Pfizer deal had sent their company’s shares rocketing.Footnote 40 By 22 April 2021, it was estimated that the BioNTech shares of Uğur Şahin and his wife were worth USD 5.9 billion.Footnote 41

The People’s Alliance for Vaccines estimated on 22 April 2021 that Pfizer had paid USD 8.44 billion in dividends in the previous year.Footnote 42 On 4 May 2021, Pfizer announced more precise figures on the profitability of its Covid-19 vaccine.Footnote 43 According to this information, the Pfizer-BioNTech vaccine brought USD 3.5 billion in revenue during the first three months of 2021, almost a quarter of its total revenue. The Covid-19 vaccine, by far, appeared to be Pfizer’s most important source of revenue.Footnote 44 Although the enterprise did not reveal the exact profits it made from the Covid-19 vaccine, it reiterated a previous prediction that the profit margins on the Covid-19 vaccine would be around 20%. This would translate into about USD 900 million in pre-tax profits on the Covid-19 vaccine with regard to Q1 2021 alone.Footnote 45

To justify its huge profits from sales of its Covid-19 vaccine, Pfizer repeatedly stressed that it had chosen not to take the federal funding offered by the Trump administration under its vaccination purchase programme “Operation Warp Speed”.Footnote 46 But BioNTech, that was the actual developer of the Pfizer-BioNTech vaccine, had itself received very substantial financial support from the German government for the development of the joint Pfizer-BioNTech vaccine. And taxpayer-funded research had helped both enterprises: E.g., the National Institutes of Health (abbreviated as NIH) had funded the technology that had made the development of the Pfizer and Moderna’s messenger RNA vaccines feasible. BioNTech had more precisely obtained a licensing agreement with the NIH for the development of the vaccine, while the further contribution of Pfizer had mainly consisted in marketing, mass-producing and commercializing the end product.Footnote 47

9.2.3.3 Moderna

The Moderna vaccine is produced by Moderna, a US biotechnology enterprise that is based in Massachusetts, and has to be stored at freezing temperature (−20 °C).Footnote 48 (Cf., furthermore, Sects. 9.3.1.2 and 9.3.1.3.)

The Moderna company was founded in 2010 by a stem cell biologist named Derrick Rossi and two private investors.Footnote 49 The company was later joined by Melissa Moore who became the biotech company’s head of mRNA technology. Under the leadership of Moore, Moderna became one of the United States’ leading biotech enterprises. By the beginning of March 2021, Moderna had thus become the owner of 23 mRNA drugs and vaccines,Footnote 50 amongst which vaccines against the Zika virus, avian flu and herpes. However, none of Moderna’s other drugs and vaccines had already been commercialized, as a result of which the enterprise was still in a loss-making phase.Footnote 51 Moderna had, moreover, obtained huge public funding—around USD 2.5 billion—for the rapid development of its Covid-19 vaccine. This helps explaining why Moderna has later on been severely criticised for the pricing of its Covid-19 vaccine, at between USD 32 to USD 37 per vaccination.Footnote 52 According to another source, early 2021, Moderna charged USD 30 for the two doses of the vaccine required in the United States and USD 36 for the two doses required in the EU.Footnote 53

By 6 March 2021, the United Kingdom had ordered 17 million doses of the Moderna vaccine, the EU 310 million doses, with an option for a further 150 million doses of the vaccine to be purchased throughout 2022, while the US government had ordered 300 million of the vaccine’s doses. Japan was said to have ordered 50 million doses of the vaccine.Footnote 54

Sales with regard to the year 2021 were expected to range between USD 18 and 20 billion.Footnote 55 Moderna itself had modestly declared that it expected sales to amount to USD 18.4 billion with regard to 2021. Barclays reached a more optimistic prospect of sales, amounting to USD 19.6 billion with regard to 2021, USD 12.2 billion in 2022 and USD 11.4 billion in 2023, the same as for recurring vaccines.Footnote 56

Because of these good results and further forecasts, Moderna’s share prices substantially increased during the period March 2020–March 2021 by 372%.Footnote 57 The group of investors who had backed the enterprise when it had been founded in 2010, were thus expected to make substantial returns. E.g., Stephane Bancel, a 48-year-old French executive who owned 9% of the company’s shares, saw her packet of shares on 6 March 2021 almost worth USD 5 billion.Footnote 58 On 22 April 1921, Stéphane Bancel’s shares were estimated to be worth $5.2 billion.Footnote 59

9.2.3.4 Johnson & Johnson (J&J)

On 6 March 2021, J&J’s vaccine was still the world’s first and only single-injection Covid-19 vaccine. The single-shot vaccine had been developed by J&J’s division located in Belgium. The J&J vaccine, in addition, was based on the so-called “adenovirus-26”, a rare variant of the common cold virus. The J&J vaccine had by the end of February 2021 been approved for temporary use in the United States. Besides its characteristic of being a one jab vaccine, the J&J vaccine had as further advantage that it can be stored at normal refrigerator temperatures for a period of at least three months (cf. Sects. 9.3.1.2 and 9.3.1.3). In early March 2021, big purchase orders had been placed in the United Sates, the United Kingdom (initially for 30 million doses, with a purchase option for an additional 22 million), the EU (good for up to 400 million doses) and the Covax initiative (good for another 500 million doses until 2022).Footnote 60

Sales for 2021 were expected to amount to USD 10 billion.Footnote 61

At the beginning of March 2021, the US government placed an order for another 100 million doses of the vaccine, with an option for purchasing an additional 200 million, and was paying USD 10 per dose.Footnote 62

J&J aimed to deliver at least 1 billion doses of its vaccine throughout 2021, which would together generate USD 10 billion.Footnote 63

By April 202122, the People’s Vaccine Alliance estimated that Johnson & Johnson had paid USD 10.5 billion in dividends and share buybacks over the preceding year.Footnote 64 J&J’s share price during the period March 2020-March 2021 increased by 7.7%.Footnote 65

9.2.3.5 Oxford-AstraZeneca (Ox-AZ)

AstraZeneca developed its Covid-19 vaccine in cooperation with Oxford University, the latter having been considered the main developer of the vaccine. The development of the vaccine was based on a modified chimpanzee cold virus. One of the main advantages of the vaccine that was already observed early upon its completion concerned the fact that the vaccine may be stored at refrigerator temperature,Footnote 66 which makes the vaccine easy to handle, transport and administer. (Cf. Sects. 9.3.1.2 and 9.3.1.3.)

By early March 2021, large orders of the Oxford-AstraZeneca vaccine had been placed by the United Kingdom (100 million doses), the EU (up to 400 million doses), the United States (300 million doses) and Japan (120 million).Footnote 67

Notwithstanding the company’s pledge not to strive for profits for the duration of the Covid-19 pandemic, sales with regard to 2021 were expected to amount between USD 2 and 3 billion.Footnote 68 SVB Leerink expected that the company’s sales would range between USD 1.9 billion with regard to 2021, and USD 3 billion with regard to 2022. The 2021 figure was expected to be even higher if AstraZeneca would meet its ambitious 3 billion dose target. As the company remained committed to providing its vaccine on a not-for-profit basis for the duration of the Covid-19 pandemic, by 6 March 2021, it was only charging USD 4.30-10 for two of the vaccine doses.Footnote 69

Due to a variety of problems that emerged with the Oxford-AstraZeneca vaccine, AstraZeneca’s share price fell by 8.6% between March 2020 and March 2021.Footnote 70 Notwithstanding the pledge not to strive for profits, by 22 April 2021, the People’s Vaccine Alliance estimated that AstraZeneca had paid USD 3.6 billion in dividends with regard to the year 2020.Footnote 71

9.2.4 Calls for an Alternative Approach

By the spring of 2021, there was a growing opposition to the business model of the pharmaceutical sector of turning Covid-19 vaccines into yet another method of making huge corporate profits to the benefit of their shareholders.

The People’s Vaccine Alliance (PVA)Footnote 72 started to argue that the profits the Covid-19 vaccine producing pharmaceutical enterprises made in 2020, were highly inappropriate as most of the world could not get access to the vaccines they needed, because they were both too expensive and, due to the monopoly of the producers, each with regard to its own vaccine, too short in supply. PVA campaigners wanted to see the Covid-19 vaccine patents waived. They also wanted the pharmaceutical enterprises, which produced the vaccines, to set up factories for making cheaper versions of the Covid-19 vaccines all around the world. PVA also pointed out that it was unacceptable that the huge need for the Covid-19 vaccines, at a time when the economy of practically all countries in the world had come at a standstill because of the Covid-19 crisis, basically but helped creating a new wave of billionaires.Footnote 73

Anna Marriott, at the time a health policy adviser at “Oxfam”, similarly, pointed out that an international, public health emergency should not have been turned into yet another opportunity for private profit, and that big pharmaceutical enterprises, moreover, should not be the ones deciding who lives and who dies in a global pandemic, all while boosting their own immense profits.Footnote 74

For Heidi Chow of “Global Justice Now”,Footnote 75 the Covid-19 vaccines had been publicly funded and had become desperately needed around the world for ending the Covid-19 pandemic. It was, therefore, morally unacceptable that the leadership of the developed world would allow a small group of enterprises to monopolize vaccine technology and keep the know-how for producing the Covid-19 vaccines under lock and key, while selling their limited doses, at huge profits, to the highest bidder.Footnote 76

Finally, in an open letter that was dated on 14 April 2021, a group of renowned people, amongst whom Former Heads of State and Nobel Laureates, jointly called on US President Biden to waive the intellectual property rules for Covid-19 vaccines. The letter was, amongst others, signed by Gordon Brown (UK Prime Minister 2007–2010), Michael Gorbachev (President of the Soviet Union 1985–1991), Eric Maskin (Noble Prize in Economics 2007), Joseph Stiglitz (Nobel Prize in Economics 2001), Archbishop Desmond Tutu (Noble Peace Prize 1984), Lech Walesa (President of Poland 1990–1995), next to numerous others. The letter read as followsFootnote 77:

We the undersigned former Heads of State and Government and Nobel Laureates are gravely concerned by the very slow progress in scaling up global COVID-19 vaccine access and inoculation in low- and middle-income countries.

The world saw unprecedented development of safe and effective vaccines, in major part thanks to U.S. public investment. We all welcome that vaccination rollout in the U.S. and many wealthier countries is bringing hope to their citizens.

Yet for the majority of the world that same hope is yet to be seen. New waves of suffering are now rising across the globe. Our global economy cannot rebuild if it remains vulnerable to this virus.

But we are encouraged by news that your Administration is considering a temporary waiver of World Trade Organization (WTO) intellectual property rules during the COVID-19 pandemic, as proposed by South Africa and India, and supported by more than 100 WTO member states and numerous health experts worldwide.

A WTO waiver is a vital and necessary step to bringing an end to this pandemic. It must be combined with ensuring vaccine know-how and technology is shared openly. This can be achieved through the World Health Organization COVID-19 Technology Access Pool, as your Chief Medical Advisor, Dr Anthony Fauci, has called for. This will save lives and advance us towards global herd immunity.

These actions would expand global manufacturing capacity, unhindered by industry monopolies that are driving the dire supply shortages blocking vaccine access. 9 in 10 people in most poor countries may well go without a vaccine this year. At this pace, many nations will be left waiting until at least 2024 to achieve mass COVID-19 immunization, despite what the limited, while welcome, COVAX initiative is able to offer.

These moves should be accompanied by coordinated global investment in research, development, and manufacturing capacity to tackle this pandemic and prepare us for future ones, as part of a more robust international health architecture. If this last year has taught us anything, it is that threats to public health are global, and that strategic government investment, action, global cooperation, and solidarity are vital. The market cannot adequately meet these challenges, and neither can narrow nationalism.

The full protection of intellectual property and monopolies will only negatively impact efforts to vaccinate the world and be self-defeating for the U.S. Given artificial global supply shortages, the U.S. economy already risks losing $1.3 trillion in GDP this year. Were the virus left to roam the world, and even if vaccinated, people in the U.S. would continue to be exposed to new viral variants.

Mr. President, our world learned painful lessons from unequal access to lifesaving treatments for diseases such as HIV. By supporting a TRIPS waiver, the U.S. will provide an example of responsible leadership at a time when it is needed most on global health — as it has done so before on HIV, saving millions of lives. Your support in rallying allies and all countries to follow your lead will also be essential.

With your leadership, we can ensure COVID-19 vaccine technology is shared with the world. Supporting the emergency waiver of COVID-19 related intellectual property rules will give people around the globe a chance to wake up to a world free from the virus. We need a people’s vaccine.

Many of us know, first-hand, the reality of political office and the pressures, challenges and constraints of leadership. However, we believe this would be an unparalleled opportunity for the U.S. to exercise solidarity, cooperation and renewed leadership, one we hope will inspire many more to do the same.

Please take the urgent action that only you can, and let this moment be remembered in history as the time we chose to put the collective right to safety for all ahead of the commercial monopolies of the few.

Let us now ensure an end to this pandemic for us all. As advocates for global and equitable vaccine access, we remain ready to support and add our voices to your efforts on this front.

By the end of April 2021, the message finally started to resonate among political leaders as well. We shall readdress this in the conclusions to this chapter. (Cf. Sect. 9.6.)

9.3 Some Major Milestones in the Race for the Development of Covid-19 Vaccines, -Drugs and -Tests

9.3.1 The Race for the Development of Covid-19 Vaccines

9.3.1.1 Underlying Research

According to Balawejder et al., the development of vaccines in general is a long and complex process, often amounting to 10–15 years and involving a combination of academic, private, and state actors. Before it is ready for use, a vaccine has to go through a series of sequential stages, for developing and testing it, as well as for establishing its quality, safety, and efficacy. Challenges associated with using complex technologies and for managing a variety of risks prolong the process. The standard stages of development and indicative timings for each of these phases are set out in Fig. 9.1.Footnote 78

Fig. 9.1
figure 1

Stylised timeline for typical vaccine development [Source: Balawejder et al. (2021), p. 10]

Still according to Balawejder et al., the length of the vaccine discovery and exploratory stage usually depends directly on the level of scientific difficulty and uncertainty involved in finding protective antigens of a specific pathogen that may be used in a safe manner for developing the vaccine. This research stage typically lasts anywhere from 2 to 4 years, as the process may be complicated by, e.g., mutating pathogens, challenges related to finding an appropriate delivery method, or difficulties in activating an immune response. The subsequent “pre-clinical trial stage” often lasts around 1 to 2 years and is considered critical before proceeding onto human clinical trials. Pre-clinical trials are conducted in order to determine the candidate vaccine’s ultimate safety profile. Such pre-clinical trials may include animal testing and testing on (human) tissue-culture systems. The most time-consuming stage of vaccine development, however, concerns the actual clinical trials. These typically take 5 to 9 years. There are usually three phases of such clinical trials, with each of these phases used to assess the response people have to the candidate vaccine. In normal cases, clinical trials take a lot of time to the extent that they involve large numbers of volunteers who are willing to test the new vaccine, as well as a process of trial and error based on emerging information on the safety and efficacy of the vaccine. Following successful clinical trials, the new vaccine then has to go through the process of regulatory approval in each jurisdiction where one wants to bring the vaccine on the market, in normal circumstances taking one to two years. This is due to complex regulatory requirements, which might include, e.g., reviews of the documentation of each of the phases, with an emphasis on the clinical trials documents, by ethics and/or biosafety committees. Finally, once the vaccine has been approved, often with an in-between temporary approval, large scale manufacturing can begin, which normally takes between 6 months and 3 years to regularize, depending on available manufacturing capacity and complexities involved in scaling up batch sizes.Footnote 79

In contrast, the Covid-19 vaccines have been made available for use in record time. While the development process for a new vaccine typically takes 10–15 years, the US FDA granted (emergency) approval to the Covid-19 vaccines manufactured by Pfizer-BioNTech, Moderna and Johnson & Johnson within a period of less than a year after the start of the Covid-19 outbreak.Footnote 80 (Cf., furthermore, Sect. 9.3.1.3) In a further past, more precisely in the 1960s, the fastest vaccine ever developed—for mumps—had taken four years.Footnote 81 In addition, the EU and UK regulatory authorities similarly approved the Covid-19 vaccines within said time frame (give or take a few weeks).Footnote 82

The fact that the world has been able to develop Covid-19 vaccines so quickly has been attributed to years of prior research into related viruses and faster ways and technologies to make vaccines, huge funding that had allowed the Covid-19 producing enterprises to run multiple trials at the same time, and regulatory agencies that acted more quickly than usual.Footnote 83

The scientific research that led to the development of the vaccines against the Covid-19 virus had indeed not begun in January 2020. For years before, researchers around the world had been investigating the related coronaviruses that cause SARS (“severe acute respiratory syndrome”) and MERS (“Middle East respiratory syndrome”), and some had been working on vaccines for dealing with these other coronaviruses. Under the form of the extremely rapid development of the Covid-19 vaccines, these efforts would in the course of 2020 pay off in a significant manner.Footnote 84

In addition, large sums of money provided by a variety of public funders (such as the Trump administration’s “Operation Warp Speed”) and private philanthropists have enabled the Covid-19 vaccine producing enterprises to conduct pre-clinical and Phase I, II and III clinal trials, as well as manufacturing, in parallel, rather than sequentially. The possibility to conduct trials and manufacturing in parallel has also been indicated as one of the mains reasons for the rapid development of the Covid-19 vaccines.Footnote 85

9.3.1.2 Early Development of the Covid-19 Vaccines

Work on the Pfizer-BioNTech Covid-19 vaccine had actually begun in January 2020, with BioNTech researchers starting to use messenger RNA (mRNA) technology for creating the genetic instructions to build a Covid-19 protein, referred to as “spike”, the idea being that, after being injected into human cells, the vaccine causes these cells to make spike proteins that are then released into the rest of the body and cause an immune system response which protects against future infection against the Covid-19 virus itself. By March 2020, BioNTech had finished the development phase of its vaccine and then decided to enter into a partnership with Pfizer in order to scale up the trial phases of the vaccine (and in order to ensure that the later production phase of the vaccine would be able to comply with future demand). The co-operating enterprises decided to give the vaccine the generic name “Tozinameran” and the brand name “Comirnaty”. The trial phase soon proved to be successful as well. In Phase I trials, researchers of the co-operating enterprises found that the Comirnaty vaccine caused human test subjects to effectively produce both antibodies and T cells against the Covid-19 virus.Footnote 86

Also in January 2020, Moderna was another enterprise that began to develop its own Covid-19 vaccine based on mRNA technology. In this case, the US government decided to fund these efforts, which resulted in the American providing nearly USD 1 billion in financial support to Moderna. In close partnership with the US National Institutes of Health, it was then quickly established that the vaccine developed by Moderna effectively protected against the Covid-19 virus. By March 2020, Moderna scientists were subsequently the first to bring their Covid-19 vaccine into human trials. After these trials showed promising results as well, phase III testing of the vaccine on 30,000 voluntary human test subjects started on 27 July 2020.Footnote 87

The Ox/AZ vaccine was similarly developed and licensed within the short time frame of one year, with its development process having differed in many ways from the usual development process. With regard to the Ox/Az vaccine, the main time savings occurred at the discovery, clinical trial and regulatory approval stages (cf. Fig. 9.2).Footnote 88

Fig. 9.2
figure 2

Process adaptations and time savings for the Ox/AZ vaccine development schedule [Source: Balawejder et al. (2021), p. 11]

Researchers at Oxford University had developed what would later become the AstraZeneca-Oxford vaccine in early 2020. The approach to this vaccine was based on the genetical modification of an adenovirus that normally contaminates chimpanzees. When the researchers then administered the vaccine to monkeys, they found that it protected said monkeys against the Covid-19 virus as well.Footnote 89 In case of the Ox/Az vaccine, the discovery phase took weeks instead of years, mainly because the Oxford scientists had been able to take advantage of technologies that had already emerged before the Covid-19 pandemic itself. As soon as the genetic sequence of the Covid-19 virus had become available in January 2020, the Oxford team of researchers had moved quickly to design a prototype vaccine. The rapid development of the prototype vaccine had especially been made possible by the technical expertise and clinical data that had been gained from developing a vaccine against another coronavirus, namely the Middle East Respiratory Syndrome (or MERS) virus.Footnote 90 In collaboration with AstraZeneca, the Oxford research team then conducted Phase I and II trials. The vaccine developers did not find any serious side effects during these trials, while at the same time coming to the conclusion that their vaccine effectively produced antibodies against the Covid-19 virus, as well as leading to other immune defences. AstraZeneca and Oxford then decided to undertake further Phase III trials in the United Kingdom, South Africa and in other countries. But the researchers made the error of conducting the trials (too) independently of each other, which made it difficult to combine their trial results into one clear and easily verifiable picture of vaccine efficacy.Footnote 91 This is thought to be one of the causes of various regulatory problems that have subsequently arisen, including with the US FDA. (Cf. throughout the following subsections.)

Finally, the research that would result into Johnson & Johnson’s Covid-19 vaccine had already started ten years before the outbreak of the Covid-19 pandemic at Beth Israel Deaconess Medical Center, located in Boston. There, researchers had come up with a method of developing vaccines from a virus called “Adenovirus 26”, or, in short, Ad26. Johnson & Johnson had already before used Ad26 for developing vaccines against Ebola and other Ad26-related diseases. In January 2020, the J&J enterprise and the researchers connected to Beth Israel decided to form a partnership for creating a vaccine against the Covid-19 virus. In March 2020, the partnership was granted 456 million from the US government to help them move into production. After experiments had indicated that the vaccine was shown to provide protection for monkeys, Johnson & Johnson initiated its Phase I and II trials in July 2020. Based on the promising results of these trials, Johnson & Johnson soon afterwards launched the Phase III trial with regard to its Covid-19 virus in September 2020. Different from the other Covid-19 vaccines that were at the time nearing completion as well, the J&J vaccine had as unique feature that it was based on a single dose instead of two. Although Johnson & Johnson had initially planned to recruit 60,000 volunteers for the Phase III trials, it capped the trials at 45,000 in December 2020 due to an increase in Covid-19 cases.Footnote 92

9.3.1.3 Some Milestones Regarding the Further Development, Testing and Regulatory Approval of the Covid-19 Vaccines

What follows in this subsection is a discussion, in outline, of some further milestones in the development, testing and approval of the Covid-19 vaccines that were at the time expected to be ready by the end of calendar year 2020, namely the Pfizer-BioNTech vaccine, the Moderna vaccine, the Oxford-AstraZeneca vaccine and the Johnson & Johnson vaccine. These four vaccines are also the four vaccines that were effectively deployed to combat the Covid-19 pandemic in the EU, the United Kingdom and the United States as of December 2020. The discussion is hereafter is in particular based on the findings of the AJMC staff, besides other sources, as referred to in footnotes.

One of these first further milestones has been that on 21 May 2020, the Trump administration and AstraZeneca announced that they would collaborate in order to accelerate the development of a Covid-19 vaccine called “AZD1222”. The HHS announced that it expected the first doses of this vaccine to be available as early as October 2020. It was also declared that the Phase III clinical studies were already underway to be conducted during the summer of 2020.Footnote 93

On 16 June 2020, by means of a subsequent important milestone, officials associated with the Trump administration’s Operation Warp Speed vaccination program announced that the Covid-19 vaccine(s), when ready, would be provided free of charge to elderly people and to other vulnerable members of the American population who would not be able to afford them.Footnote 94

Already on 14 July 2020, data from Phase I and II trials of the Moderna Covid-19 vaccine, the first vaccine to enter the trial phase, were made available. From these data, it appeared that the vaccine doses that had been provided to three groups of 15 volunteers, had all produced immunity responses.Footnote 95

As of 21 July 2020, it was announced that two of the other at the time investigational Covid-19 vaccines had shown promising results against the Covid-19-virus. One of these vaccines was from AstraZeneca, and the other from CanSino Biologics. Interim results of AstraZeneca’s COV001 phase I and II trials of AZD1222 had demonstrated that the vaccine had been well tolerated and that it had generated a robust immune response against the Covid-19 virus in all test subjects concerned. In a CanSino phase II trial, it was reported that the Covid-19 vaccine had induced “significant” results.Footnote 96

On 22 July 2020, the United States placed its first Covid-19 vaccine purchase orders. The Department of Health and the Department of Defense had partnered with biotech giants Pfizer and BioNTech for the delivery of 100 million doses of the Covid-19 vaccine candidate of said companies, BNT162. The delivery was agreed for December 2020. It was, in addition, agreed that the purchasing order could be expanded by 600 million additional doses, provided that the US FDA would grant either its approval or an emergency use authorization (EUA) to the vaccine and even then only under the condition that the results of the Phase III clinical of the vaccine would confirm its safety and effectiveness.Footnote 97

On 27 July 2020, the start of the Phase III of the clinical trials of the Moderna Covid-19 vaccine candidate was announced. It was at the same time announced that the Trump administration had increased funding to Moderna by USD 472 million. These funds were said to have been made available for expanding the Phase III trials to 30,000 US participants. This decision, moreover, brought the total investment by the Biomedical Advanced Research and Development Authority to Moderna to USD 955 million.Footnote 98 Also on 27 July 2020, Pfizer and BioNTech announced the launch of the Phase II and III trials of their own Covid-19 vaccine in which 30,000 volunteers would be participating.Footnote 99

On 3 August 2020, the United States entered into an USD 2.1 billion agreement with “GlaxoSmithKline” and “Sanofi Pasteur”, with as subject the development, manufacturing and scale up delivery of a Covid-19 vaccine.Footnote 100

On 11 August 2020, although the definitive results of the Phase III trials were not yet available, the Trump administration entered into a purchasing agreement with Moderna. In this agreement, parties agreed upon a price of USD 1.5 billion for 100 million doses of the Moderna Covid-19 vaccine candidate “mRNA-1273”, which implied an average price per single dose of USD 15. At the time, the Moderna vaccine candidate was still being studied in the Phase III “COVE” trial which Moderna was conducting in cooperation with the National Institute of Allergy and Infectious Diseases and with the Biomedical Advanced Research and Development Authority.Footnote 101

In August 2020, the US federal government entered into an agreement with Johnson & Johnson in which the United States committed to pay USD 1 billion for 100 million doses of the J&J-vaccine candidate, provided the J&J-vaccine would be ultimately approved by the competent authorities.Footnote 102

On 1 September 2020, the United States announced its unwillingness to participate in the WHO initiative entitled “COVAX” which was aimed at developing, manufacturing and distributing Covid-19 vaccines in a fair manner and on a global scale. In total 172 countries had committed their willingness to join the COVAX initiative, which was in particular launched in order to ensure that potential Covid-19 vaccines would be distributed equitably, implying that poor and developing countries would have a sufficient access to the vaccines.Footnote 103

On 3 September 2020, nineteen American bioethicists defined guidelines the United States could resort to in order to insure a fair distribution of any of the Covid-19 vaccines, especially taking into account that there would be a shortage of stocks during the beginning period of the Covid-19 vaccination campaigns. The plan was entitled the “Fair Priority Model” and was based on a model which, on one hand, took three “types of harm” caused by the Covid-19 disease into consideration, and on the other hand, three values that had to be respected in order to reach a fair distribution of a presumed insufficient amount of the Covid-19 vaccines.Footnote 104

Also on 3 September 2020, “Sanofi” and “Glaxo SmithKline” (GSK) announced that they were launching the clinical trials of their protein-based vaccine candidate. The Sanofi-GSK vaccine candidate for dealing with Covid-19 vaccine had been developed from the protein-based technology that had already been used for developing Sanofi’s influenza vaccines, in combination with an adjuvant, or booster, that had been developed by GSK.Footnote 105

On 8 September 2020, AstraZeneca announced its decision to suspend the phase III trial of its Covid-19 vaccine candidate. There appeared to be a need of a safety review of the vaccine candidate after an unknown adverse reaction to the vaccine had appeared in one test subject. The precise nature of the adverse reaction was still unknown, although AstraZeneca declared that the test subject was bound to recover. AstraZeneca, furthermore, qualified the suspension of the clinical trials for testing its vaccine candidate as a “routine action”.Footnote 106

On 14 September 2020, Pfizer and BioNTech declared that they would increase the number of test subjects partaking into the Phase III trials of their vaccine candidate by half, which brought the number of participants in the Phase III trials to 44,000. It had initially been the intention of the two enterprises to only recruit 30,000 trial participants. It was announced that the purpose of the trial expansion was to insure that the trial data would be sufficiently safe and reliable and to test the vaccine candidate on a more diverse population, including people aged 16 years and patients suffering from medical preconditions such as HIV, hepatitis C or hepatitis B.Footnote 107

Also on 14 September 2020, there was some further news how the competent authorities would deal with the suspension of the Phase III trial of the AstraZeneca vaccine candidate. The NIH announced that it wanted to launch a further investigation into the adverse effects of the vaccine candidate, before the FDA would be able to decide whether the Phase III testing trials could be resumed. In the meantime, the participant to the AstraZeneca trial who had been showing adverse effects appeared to suffer from spinal cord injuries, while there was, however, uncertainty as to the exact cause of these injuries.Footnote 108

On 16 September 2020, it was announced by the HHS and DOD that a Covid-19 vaccine would be freely available to all Americans and that the Covid-19 vaccination campaign would be rolled out as of January 2021. The joint plan, which was however still conditional upon one or more of the Covid-19 vaccine candidates receiving their license for use, also contained the aim of providing 6.6 million supply kits, necessary for administering the Covid-19 vaccine(s).Footnote 109

On 21 September 2020, Johnson & Johnson announced the commencement of its own large Phase III clinical trial of the J&J-Covid-19 vaccine candidate. It was, thereby, pointed out that the J&J-vaccine had as huge advantages that the vaccine did not need to be frozen and that it concerned a single shot vaccine, implying that there would only be a need for a single administration, instead of two. These two characteristics combined made the J&J-vaccine much easier to administer than, e.g., its mRNA counterparts. The announcement also indicated that the clinical trials were to include no less than 60,000 trial participants, making the J&J-trial phase the largest Phase III trial of any of the Covid-19 vaccines being tested at the time.Footnote 110

Until then, the EU had been playing a very passive role with regard to the purchasing of Covid-19 vaccine candidates (cf., furthermore, Sect. 9.4), as a further consequence of which it was running months behind the United States that had at the time already entered into several purchasing agreements with a variety of vaccine producers. Finally, on 8 October 2020, the EU managed to enter into an own purchasing agreement with Johnson & Johnson. This agreement concerned the purchasing of 200 million doses of the J&J-vaccine. In light of the forementioned characteristics of the J&J-vaccine, it was also especially appealing to COVAX that itself managed to secure 500 million doses of the J&J vaccine.Footnote 111

However, only a few days later, more precisely on 12 October 2020, Johnson & Johnson announced its own decision to suspend the phase III (called “TOGETHER”) trial of its Covid-19 vaccine. This decision was taken because one of the test subjects had fallen ill for reasons unclear. The J&J-enterprise further elaborated upon the matter by explaining that adverse events that temporarily halt the proceeding of the testing of a vaccine, were not uncommon and did by no means imply that the clinical trials were not being conducted in a sufficiently safe manner. The J&J-enterprise, furthermore, announced that it would continue to study its one-dose regimen, which at the time remained unique among the leading vaccine candidates. J&J also announced that it would soon start with ENSEMBLE 2, a study that had been designed for testing a two-dose version of the J&J-vaccine.Footnote 112

On 23 October 2020, AstraZeneca and Johnson & Johnson announced that they each would rekindle the clinical trials of their respective Covid-19 vaccine candidates, after both—each on its own accord—had stopped the trials shortly before because of safety concerns. Johnson & Johnson had stopped its clinical trial on 11 October 2020, while the test subject that had been partaking to AstraZeneca’s trial to fall ill afterwards, had in the meantime been diagnosed with a neurological condition.Footnote 113

On 28 October 2020, CMS established new rules for insurance coverage. These rules dealt with what Medicare would pay hospitals for Covid-19 treatments, but also provided guidelines in light of the general policy objective announced by the Trump administration that the Covid-19 vaccinations would be at zero cost for the American population.Footnote 114

On 9 November 2020, Pfizer and BioNTech released data from their Covid-19 vaccine candidate trials which indicated that their vaccine was 90% effective.Footnote 115 On 16 November 2020, this positive Covid-19 vaccine news continued with Moderna’s similar announcement that the Moderna Phase III trials had indicated that its vaccine candidate had been reducing the risks associated with Covid-19 by 94.5% in the test subjects to whom the Moderna vaccine had been administered.Footnote 116

Also on 16 November 2020, on CNBC’s program “Squawk Box”, US Health Secretary Alex Azar declared that the FDA would move “as quickly as possible” to grant the Pfizer-BioNTech and Moderna Covid-19 vaccine candidates approval for emergency use, provided that it would appear that the data with regard to the clinical trials of both vaccines would warranted such an emergency use authorisation. At the time, the applications for approval with regard to both these mRNA vaccines had been completed, with Azar further declaring that FDA teams were cooperating with both vaccine producing enterprises to “remove any unnecessary bureaucratic barriers.”Footnote 117

On 18 November 2020, it was announced that the Phase III trials of the Pfizer-BioNTech vaccine, to which nearly 44,000 test subjects had partaken, had indicated that the Pfizer-BioNTech Covid-19 vaccine was 95% effective.Footnote 118 This implied that the Pfizer-BioNTech Covid-19 vaccine was as effective as the vaccines against shingles and measles. Pfizer and BioNTech, hence, announced that they were ready to request FDA approval within days, implying that it became likely that the distribution of the Pfizer-BioNTech vaccine could still start before the end of the year 2020.Footnote 119 The submittal to the US FDA of the request for an emergency use authorization (EUA) with regard to the Pfizer-BioNTech vaccine then followed on 20 November 2020. This made Pfizer and BioNTech the first enterprises to apply for such authorisation in the United States with regard to a Covid-19 vaccine.Footnote 120

On 23 November 2020, further testing results with regard to the Oxford-AstraZeneca vaccine were announced. According to these, it appeared that when AstraZeneca’s Covid-19 vaccine was administered as a half dose, followed by a full dose at least a full month later, the vaccine appeared to be 90% effective. The main advantages of this vaccine were also highlighted. It, more in particular, appeared that the AstraZeneca Covid-19 vaccine would be far easier to preserve, transport, distribute and scale up than the mRNA vaccines, with AstraZeneca, furthermore, declaring that it would be able to produce up to 200 million doses before the end of 2020, and 700 million by the end of Q1 2021.Footnote 121

On 2 December 1920, the United Kingdom became the first Western country to approve a Covid-19 vaccine. On said date, the United Kingdom’s competent authority was, more in particular, the first in the West to license the Pfizer-BioNTech Covid-19 vaccine candidate. This also made the Pfizer-BioNTech Covid-19 vaccine the first mRNA vaccine in history to be licensed for human use.Footnote 122

On 8 December 2020, AstraZeneca and Oxford published a joint scientific paper with regard to the phase III clinical trials of the Oxford-AstraZeneca Covid-19 vaccine. From this paper, it appeared that, although the Oxford-AstraZeneca vaccine would protect people against Covid-19, there were still many unanswered questions with regard to the trial results. Nevertheless, the vaccine’s low production cost and ease of storage kept making it an attractive solution for responding to the Covid-19 pandemic, especially for the EU (as motivated by its austerity policy; cf., furthermore, Sect. 9.4.3). The first countries that subsequently would grant an emergency authorization to the Oxford-AstraZeneca Covid-19 vaccine were the United Kingdom and Argentina, which happened on 30 December 2020. Since then, several other countries followed suit. On 3 January 2021, India approved its own version of the Oxford-AstraZeneca called “Covishield” that was to be manufactured on a large scale by the Serum Institute of India.Footnote 123

On 10 December 2020, an advisory committee of the US FDA gave a positive advice with regard to the Pfizer-BioNTech Covid-19 vaccine. Said vaccine was, moreover, the first of the Covid-19 vaccines obtaining such a positive advice.Footnote 124 One day after the committee’s positive advice, on 11 December 2020, the full FDA granted approval for an emergency use authorization (EUA) for the Pfizer-BioNTech vaccine. This also implied that shipments of the vaccine could start. It was, furthermore, announced that the vaccination of healthcare laborers would already begin in the days to follow.Footnote 125 Since then, the Pfizer-BioNTech Covid-19 vaccine has received emergency approval in several other territories as well, including Canada, the EU and a variety of other countries.Footnote 126

On 10 December 2020, the New England Journal of Medicine published the results of Pfizer’s and BioNTech’s Phase III trials. From this, it appeared that the Pfizer-BioNTech vaccine “was 95% safe and effective in protecting against Covid-19 in people 16 years and older”. The FDA simultaneously published a further analysis indicating that the Pfizer-BioNTech Covid-19 vaccine was considered safe and that it already provided a strong protection against Covid-19 within 10 days upon administration of a first dose, regardless of the recipient’s race, weight or age. On 17 February 2021, the New England Journal of Medicine would publish a further (preliminary) report showing that the Pfizer-BioNTech Covid-19 vaccine remained effective in protecting against the Covid-19 virus variants that had some time before been found in the United Kingdom and Brazil (and that, at the time, were referred to as the UK variant and the Brazilian variant of the Covid-19 virus, respectively). However, the preliminary report added that the Pfizer-BioNTech Covid-19 vaccine might be less effective in providing protection against the South African variant of the Covid-19 virus, with the authors of the report adding that further research was necessary with regard to the matter.Footnote 127

Shortly after the Pfizer-BioNTech Covid-19 vaccine received a FDA granted EUA, the Moderna Covid-19 vaccine candidate would become the second Covid-19 vaccine to receive such a EUA in the United States. The Trump administration had already acted in a pro-active manner by, on 11 December 2020, having purchased an additional 100 million doses of Moderna’s Covid-19 vaccine candidate.Footnote 128 Finally, on 17 December 2020, the same FDA advisory panel that only a week before had delivered a positive advice with regard to the Pfizer-BioNTech Covid-19 vaccine, met again and this time reached the conclusion that the Moderna vaccine was both safe and would benefit people aged 18 and older. The vote with regard to the Moderna vaccine was 20-0, with one abstention.Footnote 129 The day after, on 18 December 2020, the US FDA issued its second EUA with regard to a Covid-19 vaccine. This also allowed for the start of shipments of the Moderna Covid-19 vaccine.Footnote 130

On 23 December 2020, the Trump administration placed a purchasing order for an additional 100 million doses of the Pfizer-BioNTech Covid-19 vaccine.Footnote 131

On 28 December 2020, Novavax announced that it would begin its own Phase III clinical trials, named “PREVENT-19”, to test its Covid-19 vaccine candidate (which had been given the temporary name NVX-CoV2373). Said Phase III trials were to be conducted among 30,000 volunteers residing in both Mexico and the United States.Footnote 132

On 30 December 2020, Covid-19 contamination cases in the United Kingdom were surging. This helps explaining why, on said date, UK regulators were proceeding extremely fast in approving the Oxford-AstraZeneca Covid-19 vaccine, with as further name “AZD1222”, as safe and beneficial for people aged 18 and over.Footnote 133

As the year ended on 31 December 2020, the US CDC reported that already approximately 2.8 million people residing in the United States had received a first shot of a Covid-19 vaccine. The day before, on 30 December 2020, about 14 million doses of the Covid-19 vaccines had already been distributed throughout the United States, out of a total of 20 million doses allocated.Footnote 134

On 16 February 2021, the WHO provided a recommendation with regard to the Oxford-AstraZeneca Covid-19 vaccine allowing for its emergency use in adults 18 years of age and older. Brazil gave full approval to the Oxford-AstraZeneca Covid-19 vaccine on 13 March 2021.Footnote 135

Shortly before, on 14 February 2021, AstraZeneca had announced that it would start clinical trials of its Covid-19 vaccine in children as young as six years old.Footnote 136 Meanwhile, in the United States, AstraZeneca had filed a report in which it demonstrated that millions of doses prior to its Phase III trials conducted among US volunteers, had demonstrated that the Oxford-AstraZeneca Covid-19 vaccine was safe and delivered protection against Covid-19. By then, the Biden administration had already secured enough of the Oxford-AstraZeneca Covid-19 vaccines as well, so that it would be accessible for all adults who wanted it by May 2021. However, a combination of a lack of regulatory approval (which the United States had still not granted with regard to the Oxford-AstraZeneca Covid-19 vaccine by 15 May 2021) and the fact that the United States had, nevertheless, acquired a huge stockpile of this vaccine as well, implied that the role of AstraZeneca’s Covid-19 vaccine in the US vaccination campaign remained uncertain. In addition, the United States had also been acquiring a more than sufficient stockpile of the Pfizer-BioNTech and Moderna Covid-19 vaccines, while it had also been preparing to start using the Johnson & Johnson vaccine. So it did not come as a real surprise when, on 18 March 2020, the United States announced that it would send millions of doses of its Oxford-AstraZeneca Covid-19 vaccine stockpile to its neighbouring countries Mexico and Canada. Meanwhile, AstraZeneca and Oxford University were still continuing to do research on the vaccine’s safety and efficacy.Footnote 137

On 17 February 2021, the “New England Journal of Medicine” published a preliminary report with regard to the Moderna Covid-19 vaccine, showing that the vaccine remained effective in protecting against the Covid-19 variant of the virus that had been first found in the United Kingdom and that was, therefore (at the time), referred to as the “UK variant” of the Covid-19 virus. However, the said preliminary report also indicated that the Moderna Covid-19 vaccine might be less effective in protecting against the South African variant of the Covid-19 virus, with the authors of the report however noting that further research on the matter was still needed.Footnote 138

On 24 February 2020, the US FDA delivered an analysis confirming a previous report from the hand of Johnson & Johnson itself that had stated that the J&J Covid-19 vaccine was safe and effective in preventing Covid-19. Based on trials conducted in the United States, the J&J-report had indicated that the J&J Covid-19 vaccine was 72% effective in preventing Covid-19, and 85% effective in preventing severe disease in all regions. The report, furthermore, pointed out that the J&J Covid-19 vaccine had been 64% effective in preventing the disease in South African trials, which was higher than previously reported.Footnote 139

On 25 February 2021, the journal “The Lancet” published two (then) new studies that had been conducted in Great Britain, showing that the Pfizer-BioNTech Covid-19 vaccine already offered strong protection after a single dose of the vaccine. These results confirmed earlier research on the Israeli vaccination campaign, the latter having indicated that the Pfizer-BioNTech Covid-19 vaccine had in Israel been 85% effective in protecting vaccinated people against Covid-19 within 15–28 days of a first dose only. It was argued that these (and similar) research results could give governments around the world more leniency in expanding their vaccination campaigns by delaying the administration of the second dose.Footnote 140

On 27 February 2021, Johnson & Johnson announced that the FDA had issued an EUA with regard to its single-dose Covid-19 vaccine. In technical terms, the J&J Covid-19 vaccine was approved “for use under an EUA for active immunisation to prevent coronavirus 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)” in people aged 18 years and older.Footnote 141 On 11 March 2021, the EMA similarly granted a conditional, temporary approval to the Johnson & Johnson Covid-19 vaccine. This, moreover, concerned the fourth Covid-19 vaccine that the EMA recommended for use in the European block of member states.Footnote 142

Also on 11 March 2021, Pfizer and BioNTeach announced the preliminary study results from the Israeli rollout of its vaccine. In this, it was suggested that that the Pfizer-BioNTech Covid-19 vaccine was even effective in preventing Covid-19 transmission. The companies, moreover, declared that their Covid-19 vaccine was 97% effective in preventing symptomatic cases of Covid-19, and 94% effective in preventing asymptomatic infections. These research results were, furthermore, supported by a “Mayo Clinic study”. The latter study had indicated that the mRNA Covid-19 vaccines manufactured by, on one hand, Pfizer-BioNTech and, on the other hand, Moderna had significantly reduced asymptomatic Covid-19 transmission in the United States.Footnote 143

On 12 March 2021, the WHO issued an emergency use listing to the Johnson & Johnson Covid-19 vaccine, which allowed for the acceleration of its approval by more countries. The enterprise itself announced that it would be targeting a total production of one billion doses throughout 2021.Footnote 144

By 23 March 2021, a total of more than 60 (other) Covid-19 vaccines were still undergoing the three-step clinical trial process that is required before their producers would be able to ask for a regulatory approval, with many of them having commenced the three trial phases simultaneously.Footnote 145 By the same date, Pfizer and BioNTech had entered into several agreements with the US government that guaranteed the latter a supply of an additional 300 million doses of the vaccine by 31 July 2021.Footnote 146

In April 2021, Pfizer and BioNTech issued a new research report showing that their vaccine was 91% effective in preventing Covid-19 disease. The report cited updated research results that included data from more than 12,000 people fully vaccinated for a duration of at least 6 months.Footnote 147

On 3 May 2021, it was announced that the US FDA was preparing for the approval of the Pfizer-BioNTech’s Covid-19 vaccine with regard to adolescents aged between 12 and 15 years. This approval for usage of the Pfizer-BioNTech Covid-19 vaccine on youngsters came highly anticipated, after Pfizer and BioNTech had themselves reported in March 2021 that, from a clinical trial, it had appeared that their Covid-19 vaccine had appeared to be safe and effective and to produce robust antibody responses in 12–15 year olds. It was thereby expected that licensing the vaccine for the age group of young people between 12 and 15 years old would boost the US immunisation campaign and help allay parents’ fears about protecting their children against Covid-19. Around the same time, Moderna and Johnson & Johnson were also testing their Covid-19 vaccines on children aged between 12 and 18. Furthermore, both Pfizer and Moderna had launched trials with even younger children, aged six months to 11 years. Both enterprises had indicated that they hoped to be able to start vaccinating children under 11 by early 2022.Footnote 148

On 7 May 2021, the Pfizer and BioNTech pharmaceutical partnership began its application with the US FDA for obtaining a full approval of the Pfizer-BioNTech Covid-19 vaccine. By that date, there had already been more than 170 million doses of the Pfizer-BioNTech Covid-19 vaccine dispensed throughout the United States under the in December 2020 obtained EUA. The two enterprises indicated that they had started the application procedure for full approval by submitting a so-called “Biologics License Application” (abbreviated as “BLA”).Footnote 149 Under full licensure, it was expected that the enterprises would be able to market the vaccine directly to Americans and that employers and schools would be less reluctant in making vaccination a condition for maintaining employment or for retaining school attendance. Full licensure was also expected to help convincing parts of the population that had been reluctant to vaccinate.Footnote 150

On 10 May 2021, US regulators approved the Pfizer-BioNTech Covid-19 vaccine for use in children as young as 12 years old. This decision implied that the FDA had decided to include children aged 12 to 15 years in the already granted EUA, with the two vaccine manufacturers however indicating that they had started the full approval process with regard to this age group as well.Footnote 151

Table 9.2 gives an overview of some characteristics of the main vaccines in March 2021.

Table 9.2 Main vaccines in March 2021a

9.3.1.4 Problems with AstraZeneca’s and Johnson & Johnson’s Regulatory Authorisation in the United States and Elsewhere

9.3.1.4.1 Regulatory Issues with AstraZeneca’s Covid-19 Vaccine

By February 2021, COVAX (cf. Sect. 9.3.1.3) had finally began delivering millions of doses of the AstraZeneca Covid-19 vaccine to low- and middle-income countries. It was the enterprise’s intent to supply these countries with Covid-19 vaccine doses based on a projected annual production capacity of two billion doses. However, after millions of people had received the vaccine, a major concern emerged. More in particular, in South Africa, a small trial with regard to the Oxford-AstraZeneca Covid-19 vaccine indicated that it might not protect people, in a sufficient manner, against the B.1.351 variant of the Covid-19 virus, which had become predominant in the country.Footnote 152 As a result, on 7 February 2021, South Africa halted all plans to further distribute an additional one million doses of the Oxford-AstraZeneca Covid-19 vaccine.Footnote 153

Meanwhile, on 22 March 1921, Oxford University and the Anglo-Swedish company AstraZeneca had become the fourth team to provide results from a large-scale Phase III trial with regard to their Covid-19 vaccine that could result into the FDA issuing a EUA for a vaccine against Covid-19 in the United States. (Cf. Sect. 9.3.1.3) AstraZeneca had indicated that, according to a 32,000-person trial—which had included volunteers from the United States, Chile and Peru—its vaccine had shown 79% efficacy against Covid-19 with any symptoms. AstraZeneca had also claimed that the Oxford-AstraZeneca Covid-19 vaccine was 100 per cent effective against severe Covid-19. However, on that same night, the US National Institute of Allergy and Infectious Diseases made the surprising announcement that experts overseeing the trial had stated their concern that AstraZeneca might have included outdated data in its trial, possibly resulting in an incomplete picture of efficacy data.Footnote 154 Shortly afterwards, on 25 March 2021, AstraZeneca managed to present the full results of the primary analysis of its US Phase III clinical trials, this time indicating that the Oxford-Astrazeneca Covid-19 vaccine was 76% (instead of the original 79%) effective in protecting against Covid-19, and 100% effective for providing protection against severe cases. AstraZeneca’s new study, moreover, did not show an increased risk of blood clots or other serious safety concerns.Footnote 155 (On the risks regarding blood clots or similar side effects, cf. Sect. 9.3.1.4.3).

In the meantime, at first the Oxford-AstraZeneca Covid-19 vaccine alone, but ultimately also the Johnson & Johnson Covid-19 vaccine, started to pose several major problems in Europe, including problems regarding the regulatory approval required for their (continued) use. After major uncertainties about the age categories for which the Oxford-AstraZeneca Covid-19 vaccine was—or was not—suitable, followed by major discussions between the EU and AstraZeneca about huge delivery delays—which caused the already slackening European vaccination campaign to be even delayed further (cf., furthermore, Sect. 9.4.3)–, as of the second half of March 2021, there also appeared to be major issues regarding serious side effects of the Oxford-AstraZeneca Covid-19 vaccine (limited in number, but large in consequences). In addition, the conflicting attitudes between the EMA—which kept proclaiming that the Oxford-AstraZeneca Covid-19 vaccine was sufficiently safe, and that its advantages outweighed its possible risks—and the medical regulators of some of the EU member states, made it impossible for the general public to still estimate the sufficient degree of effectiveness and safety of the vaccine, resulting in a crisis of confidence that endangered the EU vaccination campaign even further.

A major, underlying problem was that, driven by an extreme degree of neoliberal austerity, the EU had, in the fall of 2020, focused its purchasing policy largely on the two cheapest Oxford-AstraZeneca and Johnson & Johnson Covid-19 vaccines, and to a much lesser extent on the two more expensive, albeit more effective Pfizer-BioNTech and Moderna mRNA based vaccines. When later it appeared that AstraZeneca made its deliveries to the United Kingdom a priority, and that Johnson & Johnson would be delivering its vaccines much later than originally planned, the EU vaccination campaign started already running behind schedule early in 2021. These delays would, moreover, determinate the EU vaccination campaigns until late April 2021 (cf. Sect. 9.4.3.10) By contrast, in some of the countries that had bet on the more expensive Pfizer-BioNTech and Moderna Covid-19 vaccines—including Israel and the United States, besides several Arab oil producing countries—the vaccination campaigns made more progress. Probably for this reason, the EMA—backed by the regulatory authorities of certain EU member states—was not readily inclined to revert the approvals with regard to the use of the Oxford-AstraZeneca Covid-19 vaccine, even after several people had died because of side effects.Footnote 156

However, some of the EU Member States gradually distanced themselves from the Oxford-AstraZeneca Covid-19 vaccine.Footnote 157

Preliminary researchFootnote 158 published on 20 April 2021 by a German team that had been focusing their research on unusual blood clots in people who had received the Oxford-AstraZeneca Covid-19 vaccine suggested that a number of components of the vaccine may indeed have been contributing to bloods clots in very rare cases. The conclusion of the research was that:Footnote 159

ChAdOx1 nCoV-19 vaccine constituents (i) form antigenic complexes with PF4, (ii) EDTA increases microvascular permeability, and (iii) vaccine components cause acute inflammatory reactions. Antigen formation in a proinflammatory milieu offers an explanation for anti-PF4 antibody production. High-titer anti-PF4 antibodies activate platelets and induce neutrophil activation and NETs formation, fueling the VITT prothrombotic response.

Professor Andreas Greinacher from the University of Greifswald, moreover, indicated that the proteins and other molecules in the Oxford-AstraZeneca Covid-19 vaccine produced “complexes” that, for some people, caused the immune system to overreact, ultimately leading to blood clots.Footnote 160 Greinacher, furthermore, expressed his belief that the risk of blood clotting could be reduced by removing the proteins that remain in vaccines after the manufacturing process and by reducing the levels of an additive named EDTA. However, Greinacher also stressed that vaccine producers would need to consider with great care what changes could be made to their vaccines without affecting their overall safety and efficacy.Footnote 161

9.3.1.4.2 Regulatory Issues Concerning the Johnson & Johnson Vaccine

The Johnson & Johnson (J&J) Covid-19 vaccine received an EUA from the FDA on 28 February 2021, after which Johnson & Johnson could begin distributing doses of its vaccine throughout the United States.Footnote 162 (Cf. Sect. 9.3.1.3.)

However, on 13 April 2021, the FDA urged states to temporarily stop using Johnson & Johnson’s Covid-19 vaccine “out of an abundance of caution”, after six women in the United States had developed a rare blood clotting disorder that resulted in the death of one woman and the critical condition of another.Footnote 163 Johnson & Johnson itself responded to the news with a statement in which it indicated that, while “no clear causal relationship” had been identified between the blood clots and its vaccine, the enterprise would be working closely together with the regulatory authorities in order to evaluate all relevant data.Footnote 164

Dr Anne Schuchat, at the time senior deputy director of the CDC, added to this explanation that people who had received the Johnson & Johnson Covid-19 vaccine more than a month earlier, had a very low risk of developing blood clots, but that people who had received the Johnson & Johnson Covid-19 vaccine within the previous two weeks should remain alert to any symptoms, such as severe headaches, abdominal pain, leg pain or shortness of breath. According to Schuchat, blood clotting usually occurs within on and three weeks after being administered the vaccine, with median time frame being nine days.Footnote 165

The impact of the mandatory pause in Johnson & Johnson’s goal of delivering 100 million doses in the United States by the end of May 2021 was at the time still unclear, as the company has already before faced manufacturing problems after a facility run by Emergent BioSolutions had ruined 15 million doses of the vaccine.Footnote 166

Meanwhile, on 20 April 2021, the EMA similarly announced that it had also found a plausible connection between Johnson & Johnson’s Covid-19 vaccine and rare cases of unusual blood clotting disorders, “very similar” to those that had in some cases occurred after the administration of the Oxford-AstraZeneca Covid-19 vaccine. At the same time, the EMA recommended that a warning be added to the Johnson & Johnson Covid-19 vaccine’s product information, while stressing that the benefits of the vaccine still outweighed its risks.Footnote 167 The EMA’s announcement of 20 April 2021 came as the European Commissioner responsible for the EU vaccine procurement had expressed his continued confidence that the 27 EU Member States would have enough doses of Covid-19 vaccines in order to fully vaccinate 70% of their adult population by mid-July 2021,Footnote 168 although in reality the EU vaccination campaign had been progressing slowly compared to the one of the United States and the United Kingdom. (Cf. Sect. 9.4.3.1.)

According to scientific information and analytics provided by the company “Airfinity”, the suspension of the Johnson & Johnson Covid-19 vaccine could delay efforts to inoculate most people in the EU by more than two additional months. Not being able to use the Johnson & Johnson vaccine, was more in particular expected to push the timeline for vaccinating 75% of the population back into December 2021, compared with an earlier expected date of 30 September 2021.Footnote 169 With regard to the United States, a lack of the Johnson & Johnson Covid-19 vaccine could push back reaching the 75% threshold to 17 September 2021, from an earlier expectation of 22 July 2021.Footnote 170 In the meantime, reports in the week between 13 April 2021 and 20 April 2021, suggested that the United States could decide to lift its suspension of the Johnson & Johnson Covid-19 vaccine on 22 April 2021, although possibly with restrictions for some age/gender groups.Footnote 171

Concerns over the Johnson & Johnson Covid-19 vaccine were similar to earlier concerns over the Oxford-AstraZeneca in March 2021, when several European countries had temporarily suspended its use because of unusual blood clots that had occurred in a small proportion of the people to whom the vaccine had been administered (cf. Sect. 9.3.1.4.1).Footnote 172 In addition to the above-mentioned eight cases in people who had been administered the Johnson & Johnson Covid-19 vaccine, all in the United States, the EMA reported about 287 similar incidents in people who had been administered the Oxford-AstraZeneca Covid-19 vaccine, 142 of them in Europe. In contrast, the figures on the Pfizer-BioNTech and Moderna Covid-19 vaccines only amounted to 25 and 5 respectively.Footnote 173 It was indicated that, with regard to the number of people who had been administered the latter two Covid-19 vaccines, the number of unusual clotting events observed so far were “lower than what we would expect in the general population”.Footnote 174

The vaccination programme of the EU had already been suffering severely from a wide variety of supply shortages and logistical problems for all possible vaccines at the beginning of 2021 and was finally picking up some speed by the end of April 2021, which helps explaining why the EU did not feel alarmed by the problems with the Johnsons & Johnson Covid-19 vaccine, and simply ordered 200 million extra doses.Footnote 175

However, Johnson & Johnson’s problems were far from over. E.g., on 22. April 2021, a US FDA inspection report of 4 April 2021 revealed that unsanitary conditions and other problems at a Johnson & Johnson manufacturing facility in Baltimore, Maryland, had been responsible for the destruction of over 15 million doses of the Johnson & Johnson Covid-19 vaccine. The FDA declared that the facility operated by Emergent BioSolutions—one of the Johnson & Johnson production companies—had “not [been] maintained under clean and sanitary conditions”.Footnote 176

In addition, on 3 May 2021, Denmark announced that it would not include the Johnson & Johnson Covid-19 vaccine in its further national vaccination campaign, referring to the various concerns about serious side effects, involving blood clots.Footnote 177 The exclusion from the Danish vaccination campaign of the Johnson & Johnson Covid-19 vaccine—which had accounted for about one third of Denmark’s prospected supply of Covid-19 vaccines—was expected to delay the country’s vaccination campaign by four weeks. However, the health authority still indicated that it could reassess the use of both the Johnson & Johnson and Oxford-AstraZeneca Covid-19 vaccines in case the situation would still change.Footnote 178 At that time, of the 5.8 million inhabitants of Denmark, 11.5% had been fully vaccinated against Covid-19, while a further 23.4% had received a first dose of a Covid-19 vaccine.Footnote 179

In contrast to the position taken by Denmark, on 10 May 2021, German Health Minister Jens Spahn announced that Germany would make the Johnson & Johnson’s Covid-19 vaccine available to all adults, regardless of age or pre-existing health condition, as part of a two-pronged strategy to counter the reluctance of older people to receive viral vector-based vaccines. The Minister explained that anyone who wished to receive the Johnson & Johnson Covid-19 vaccine, would be able to do so on a single occasion, provided they were fully informed of the extremely low risk of a rare blood clotting disease associated with the vaccine.Footnote 180

9.3.1.4.3 Other Effects of Regulatory Issues Related to the Oxford-AstraZeneca and Johnson & Johnson Covid-19 Vaccines

The potential risk of blood clots from the Oxford-AstraZeneca and Johnson & Johnson Covid-19 vaccines would afterwards continue to prompt different policy responses across Europe: E.g., the French government retained confidence in the Oxford-AstraZeneca Covid-19 shot, at the same time announcing it would also start using the Johnson & Johnson Covid-19 vaccine.Footnote 181

Nevertheless, by mid-April 2021, Denmark was not the only Scandinavian country that had developed serious doubts about one of the Covid-19 vaccines. At the moment that Denmark announced its decision that its vaccination campaign would go ahead without the Oxford-AstraZeneca Covid-19 vaccine (cf. Sect. 9.3.1.4.1), Sweden said that it planned to pause its own roll-out of the Covid-19 vaccine produced by Johnson & Johnson.Footnote 182 Finland announced that it would continue to restrict the Oxford-AstraZeneca Covid-19 vaccine to people aged 65 and over, adding that it could possibly provide a second dose from another manufacturer to people who had already been administered a shot with the Oxford-AstraZeneca Covid-19 vaccine, and that it was preparing a plan on how to continue its vaccinations.Footnote 183

Most other EU countries decided to resume vaccinations with the Oxford-AstraZeneca Covid-19 vaccine, but a dozen, including France, Germany, Italy and Spain, decided to restrict its use to people over 55, 60 or 65.Footnote 184

9.3.1.5 Interval and Mixed Dosing in Relation to the Need for a Third Dose and Regular Booster Injections

In the EU, given the shortages of Covid-19 vaccines at the start of the Member States’ vaccination campaigns early-2021, scientists began to look for ways to manage shortages, e.g., by adjusting the dosing intervals of the vaccines.

As it became considered vital to roll out vaccinations more rapidly in order to protect as many people as possible and to reduce the possibility of Covid-19 virus spread, solutions had to be found to the disastrous management of the Covid-19 vaccine processing by the EU’s responsible bureaucrats (cf., furthermore, Sects. 9.4.3.3 and 9.4.3.4). In order to achieve such a more rapid roll-out of the vaccination campaigns and given the limited number of doses available, the interval between doses 1 and 2 of the Covid-19 vaccines that require two doses, was hence widely discussed within the context of the EU/EEA, as well as by the WHO Strategic Advisory Group of Experts on Immunisation (abbreviated as “SAGE”). Before, the Covid-19 vaccine product information as recommended by the EMA, had indicated that the second dose of the BioNTech-Pfizer Comirnaty vaccine had to be administered three weeks (or 21 days) after the first jab. For the interval between the first and the second dose of the Moderna Covid-19 vaccine, 28 days were deemed advisory. However, in response to the extreme Covid-19 vaccine shortages the EU/EEA were facing, the WHO came up with new recommendations that the interval between the two doses of the Pfizer-BioNTech and Moderna Covid-19 vaccines could be expanded to 42 days (or 6 weeks). Similarly, with regard to the Oxford-AstraZeneca Covid-19 vaccine, the EMA had initially granted conditional approval for the use of the vaccine under the recommendation that the interval between the two doses of said vaccine would amount to four to twelve weeks. Here, the sudden new insight became that greater vaccine efficacy would be obtained by prolonging the interval between the first and the second dose of the vaccine, and that a single dose of the Oxford-AstraZeneca Covid-19 vaccine would be sufficiently effective for 90 days after the administration of the first shot of the vaccine. As a result, the WHO SAGE interim recommendations on the administration of the Oxford-AstraZeneca Covid-19 vaccine started advising that the second dose would best be administered between 8 and 12 weeks after the first jab. This was motivated under a purportedly increased immunogenicity in case of a prolonged interval between doses.Footnote 185

According to the same regulators, new evidence had also emerged on the efficacy of the different Covid-19 vaccines after the administration of a single dose.Footnote 186 Other evidence on the dosing of the Covid-19 vaccines referred to by the ECDC dealt with the number of doses of a Covid-19 vaccine that people who had already been infected with Covid-19 in the past (still) needed.Footnote 187 Mathematical modelling was used to estimate the impact of changing the dose interval.Footnote 188

Given the fact that all available Covid-19 vaccines target the Covid-19 virus’ spike protein to induce immunity, the possibility of using a mixed vaccination schedule, by administering a second dose that was based on a different Covid-19 vaccine product than the first dose, were also explored. It was considered that such a mixed schedule could, potentially, contribute to better protection, as well as adding more flexibility to vaccine deployment.Footnote 189

In mid-April 2021, when most people in the European Union still had no clear idea when they would receive their first jab of a Covid-19 vaccine, and European and British scientists were beginning to play with ideas of intervals and dose mixes to cope with vaccine shortages, the United States in contrast started to prepare for the possibility that a so-called booster—or third—shot might be needed between nine and 12 months after the first jab of a Covid-19 vaccination. As the topic of post-vaccination immunity got further investigated, it became clear that booster shots would most likely be needed, although there was not yet a clear insight about the ideal interval between the second jab and such a booster jab. It was, moreover, soon assumed that annual revaccination could become necessary, depending on the further behaviour of the variants of the Covid-19 virus.Footnote 190 Initial data had, in any case, indicated that the Covid-19 vaccines developed by Moderna and by the cooperating partners Pfizer and BioNTech retained most of their efficacy for a period of at least six months, although it was not known how much longer. Although it seemed that the protection provided by the mRNA Covid-19 vaccines would last well beyond these six months, the rapid spread of the already existing variants of the Covid-19 virus, as well as others that might still emerge in the future, added to the likelihood that regular booster shots would become necessary (as regarding annual flu vaccines).Footnote 191

9.3.1.6 Ethical Considerations of the Catholic Church

Once some of the Covid-19 vaccines were getting ready for use, i.e., in November-December 2020, a debate started to emerge within the Catholic Church whether some of the Covid-19 vaccines were sufficiently compliant with the Church’s teachings. This was because the development, but also the testing, of some of the Covid-19 vaccines relied on cell material (notably cell lines) from aborted fetuses. This was in particular the case for the Oxford-AstraZeneca and Johnson & Johnson Covid-19 vaccines, as regards the development, production, and testing of these vaccines, and for the Pfizer-BioNTech and Moderna Covid-19 vaccines, as regards the testing of the vaccines.Footnote 192

As of December 2020, this matter came to the attention of several church authorities, whereby the distinction between, on one hand, the vaccines which were deemed to be most in contradiction with the church doctrine (so especially the Oxford-AstraZeneca and Johnson & Johnson Covid-19 vaccines), and, on the other hand, vaccines which were to a lesser extent deemed in contradiction which church doctrine (notably the Pfizer-BioNTech and Moderna Covid-19 vaccines) was explicitly acknowledged.Footnote 193

In this, church authorities seemed to rely on a “lesser” or “more” evil doctrine, whereby:

  1. (1)

    The bigger evil concerns the use of abortion-derived cell lines in the manufacturing and/or development of vaccines.

  2. (2)

    The lesser evil concerns the use of such cell lines only in the (confirmatory) test phase (in order to get approval) of the vaccines, and not in the research, development and production of the vaccines.

Already in the leading encyclical “Evangelium vitae” by Saint John Paul II, a clear position had been taken against the use of (tissue, or material from) aborted fetuses for medical purposes.

Thus, the encyclical determines:Footnote 194

63. This evaluation of the morality of abortion is to be applied also to the recent forms of intervention on human embryos which, although carried out for purposes legitimate in themselves, inevitably involve the killing of those embryos. This is the case with experimentation on embryos, which is becoming increasingly widespread in the field of biomedical research and is legally permitted in some countries. Although “one must uphold as licit procedures carried out on the human embryo which respect the life and integrity of the embryo and do not involve disproportionate risks for it, but rather are directed to its healing, the improvement of its condition of health, or its individual survival”, it must nonetheless be stated that the use of human embryos or fetuses as an object of experimentation constitutes a crime against their dignity as human beings who have a right to the same respect owed to a child once born, just as to every person.

This moral condemnation also regards procedures that exploit living human embryos and fetuses-sometimes specifically “produced” for this purpose by in vitro fertilization-either to be used as “biological material” or as providers of organs or tissue for transplants in the treatment of certain diseases. The killing of innocent human creatures, even if carried out to help others, constitutes an absolutely unacceptable act.

In a formal letter from the Vatican (more precisely from the “Pontificia Academia pro vita”) regarding vaccines based on aborted fetal material dated 9 June 2005, the position of the Vatican had even been made more clear.Footnote 195 This letter constituted a response to a question addressed at the time to His Eminence Pope Benedict XVI, then still a cardinal. In summary, the position of that letter (clearly building on “Evangelium vitae”) was that the development and use of vaccines which rely on aborted fetal material is an “evil” thing (= “evil” in terms of Catholic teaching), and that participation in this evil increases the more knowledge and insight one has with regard to the matter.Footnote 196

It was hereby explicitly acknowledged that, e.g., doctors have a duty, if an alternative vaccine is available (which is not based on material from an aborted fetus), to work to ensure that this vaccine is used (even in their attitude towards the government):

Therefore, doctors and fathers of families have a duty to take recourse to alternative vaccines (if they exist), putting pressure on the political authorities and health systems so that other vaccines without moral problems become available. They should take recourse, if necessary, to the use of conscientious objection with regard to the use of vaccines produced by means of cell lines of aborted human fetal origin. Equally, they should oppose by all means (in writing, through the various associations, mass media, etc.) the vaccines which do not yet have morally acceptable alternatives, creating pressure so that alternative vaccines are prepared, which are not connected with the abortion of a human fetus, and requesting rigorous legal control of the pharmaceutical industry producers.

The letter of 9 June 2005, furthermore, speaks of a “duty of the physician”, as well as of the householder, to invoke a fundamental conscientious objection in the event that the use of such a troubled vaccine is at stake.

See, e.g., explicitly footnote 14 of the June 9, 2005, letter:

Such a duty may lead, as a consequence, to taking recourse to “objection of conscience” when the action recognized as illicit is an act permitted or even encouraged by the laws of the country and poses a threat to human life. The Encyclical Letter Evangelium Vitae underlined this “obligation to oppose” the laws which permit abortion or euthanasia “by conscientious objection”.

One of the general conclusions of the 9 June 2005 reached in the letter implies that there is a grave responsibility to use alternative vaccines, and to make a conscientious objection to those vaccines which cause moral problems.

The matter was readdressed in a 2008 Congregation for the Faith-statement “Dignitas personae”,Footnote 197 dating back to the era of Pope Benedict XVI, in which the following was stated on the subject:

In this regard, the criterion of independence as it has been formulated by some ethics committees is not sufficient. According to this criterion, the use of “biological material” of illicit origin would be ethically permissible provided there is a clear separation between those who, on the one hand, produce, freeze and cause the death of embryos and, on the other, the researchers involved in scientific experimentation. The criterion of independence is not sufficient to avoid a contradiction in the attitude of the person who says that he does not approve of the injustice perpetrated by others, but at the same time accepts for his own work the “biological material” which the others have obtained by means of that injustice. When the illicit action is endorsed by the laws which regulate healthcare and scientific research, it is necessary to distance oneself from the evil aspects of that system in order not to give the impression of a certain toleration or tacit acceptance of actions which are gravely unjust. Any appearance of acceptance would in fact contribute to the growing indifference to, if not the approval of, such actions in certain medical and political circles.

In light of these official Church teachings, shortly after the first Covid-19 vaccines were reported about in medical journals and in the press, several US Catholic bishops expressed their viewpoints on the morality of the Covid-19-vaccines in an open letter dated 14 December 2020 (entitled “a letter to the faithful from the Colorado bishops on COVID-19 vaccines”).Footnote 198 The letter, published on the website “Denver Catholic,” reminded that Catholics have a duty to use vaccines that respect human life, when available. The bishops, while describing the vaccines for Covid-19 “necessary and urgent,” also state that “a good end cannot justify evil means”Footnote 199:

In the case of the Pfizer and Moderna COVID-19 vaccines, their use is morally acceptable since neither company used fetal cell lines from an aborted baby at any level of design, development, or production. However, we must also acknowledge that these two vaccine options are not untouched by abortion, as both relied on fetal cells from an aborted baby for one of the confirmatory lab tests. In our current circumstances, when better options are not available, the use of the Pfizer and Moderna vaccines remains a morally valid option. On the other hand, vaccines such as AstraZeneca-Oxford use aborted fetal lines in design, development, production, and testing, and therefore are not a morally valid option because better options are available.

Catholics have the duty to use vaccines that respect human life, when they are available. We are thankful that many of the companies and countries working to protect human life and health from COVID-19 are also considering the ethical development and trials of their vaccines.

The letter of 14 December 2020 clearly opposed the use of the Oxford-AstraZeneca and Johnson & Johnson Covid-19 vaccines, to the extent that there are (ethically speaking) better alternatives available (e.g., the Moderna and Pfizer-BioNTech Covid-19 vaccines).

However, the US bishops did not have the final word in the matter. In a more recent statement of the Vatican itself of 21 December 2020, a slightly more liberal approach to the matter was consideredFootnote 200:

In this sense, when ethically irreproachable Covid-19 vaccines are not available (e.g., in countries where vaccines without ethical problems are not made available to physicians and patients, or where their distribution is more difficult due to special storage and transport conditions, or when various types of vaccines are distributed in the same country but health authorities do not allow citizens to choose the vaccine with which to be inoculated) it is morally acceptable to receive Covid-19 vaccines that have used cell lines from aborted fetuses in their research and production process.

This new position of the Vatican seemed to imply a slight step back with regard to the previously elaborated Church doctrine going back to “Evangelium vitae”.

This relaxation was specifically justified in light of the Covid-19-pandemic.

In a news report from “Vatican news”, this “step back” was explained as followsFootnote 201:

The “Note on the morality of using some anti-Covid-19 vaccines” recalls three previous pronouncements on the same topic: one from the Pontifical Academy for Life (PAV) in 2005; the CDF Instruction Dignitas Personae in 2008; and, another note from the PAV in 2017.

(…)

Therefore, argues the note published on Monday in summing up the Instruction of 2008, “when ethically irreproachable Covid-19 vaccines are not available”, it is “morally acceptable to receive Covid-19 vaccines that have used cell lines from aborted fetuses in their research and production process.

In other words, there was no longer a “total” or “absolute” condemnation of vaccines that rely on cell lines from aborted fetal material in their research and development phase, although they may only be used if there are no less ethically compromised alternatives available.

Otherwise put, even in the new statement of 21 December 2020, (as in the 2005-doctrine itself), the idea that one should preferentially fall back on the less ethically compromised vaccines remained expressed. From this, it can be inferred that a “gradation” was (still) at play, even in the 21 December 2020 statement (which was, in essence, what the position of the US bishops of 14 December 2020 amounted to). In this regard, the 21 December 2020 statement keeps considering vaccines that rely on cell lines from aborted fetal material in their research and development phase as (ethically) less valid, which implies that their use should preferably be avoided if other alternatives are available. Vaccines that have only used aborted tissue in the testing phase (such as the Pfizer-BioNTech and Moderna Covid-19 vaccines) were hereby, as such, not explicitly mentioned in the 21 December 2020 statement, and were, hence, not subject to the same moral judgement as vaccines that do rely on cell lines from aborted fetal material in their research and development phase (notably the Oxford-AstraZeneca and Johnson & Johnson Covid-19 vaccines).

From this, it seems to follow that the 21 December 2020 statement does not represent a complete caesura with the Episcopal Letter (from the hand of the above-mentioned US Bishops) of 14 December 2020, since the 21 December 2020 statement also reflects greater moral judgment against vaccines that rely on cell lines from aborted fetal material in their research and development phase, than against vaccines that do not.

One of the major differences between the two approaches seems to be that the Episcopal letter of 14 December 2020, mentions the several Covid-19 vaccines by name, which is not the case in the Vatican statement of 21 December 2020. A second difference seems to regard the fact that in the Episcopal letter of 14 December 2020, the availability of alternative vaccines which, in their research and development phase, do not rely on cell lines of aborted foetal material, is an axiom (= it is acknowledged, in an outspoken manner, that such alternative vaccines do exist, notably the Pfizer-BioNTech and Moderna Covid-19 vaccines, which is why they are also mentioned by name in the letter), to which the Vatican’s statement of 21 December 2020 only refers as a hypothetical possibility (which is somewhat strange, to the extent that, at the time the statement was made, vaccines that do not rely on cell lines from aborted fetal material in their research and development phase, already existed). A third difference is that the 21 December 2020 statement is somewhat more lenient regarding the logistical problems (e.g., transportation and preservation) posed by the ethically superior vaccines (i.e., the Pfizer-BioNTech and Moderna Covid-19 vaccines). Also on this point, the 21 December 2020 statement seems to make a concession to the earlier church statements and positions.

It is, however, noteworthy to mention that the Vatican itself purchased the Pfizer-BioNTech Covid-19 vaccine, which was then also used to vaccinate the two popes (Francis I and Benedict XVI).Footnote 202 It was also announced that all inhabitants and further personnel of the Vatican would all be vaccinated with the Pfizer-BioNTech Covid-19 vaccine. In other words, the Vatican itself clearly chose for the Pfizer-BioNTech Covid-19 vaccine, entirely in line with the gradation contained in its own statement of 21 December 2020, which stipulates that to the extent that less objectionable alternatives are available, a vaccine based on cell lines of aborted tissue in the production or development phase should preferably not be chosen. As a result, the Vatican’s purchasing and vaccination behaviour was also, de facto, fully in line with the statement of the US bishops of 14 December 2020, which allows e.g., the use of the Pfizer-BioNTech Covid-19 vaccine, but rejects e.g., the Oxford-AstraZeneca Covid-19 vaccine.

It is, however, not only the American bishops who raised questions of conscience. This was also the case for, e.g., the Australian archbishop Anthony Fisher, in an opinion piece of 4 August 2020 already.Footnote 203 In doing so, the Australian archbishop nicely summarized the possible positions any person, but especially a Catholic, may assume:

Of course, many people will have no ethical problem with using tissue from electively aborted fetuses for medical purposes.

Others may regard the use of a cell-line derived from an abortion performed back in the 1970s as now sufficiently removed from the abortion itself to be excusable.

But others again will draw a straight line from the ending of a human life in abortion, through to the cultivation of the cell-line, to the manufacture of this vaccine. They won’t want to be associated with or benefit in any way from the death of the baby girl whose cells were taken and cultivated, nor to be thought to be trivializing that death, nor to be encouraging the fetal tissue industry.

I, for one, don’t think it would be unethical to use this vaccine if there is no alternative available. To do so would not be to co-operate in any abortion occurring in the past or the future. But I am deeply troubled by it.

In summary: (1) a first group of people will be completely unconcerned. (2) A second group will point out that the cell lines used date back to the 1970s and that this provides a ground for exculpation. (3) But others will continue to feel that the matter at hand should not be trivialized. The Australian archbishop arrived at a position of his own that is very much in line with the teachings of the 2005 church letter: using the compromised vaccines only in the absence of alternatives, in addition to a continued call for medical science to work to develop alternatives. However, in the approach of the Australian archbishop, the idea is echoed that it is ultimately a question of (individual) conscience.

That the issue remained very much alive may be shown, e.g., by various Church positions that continued to emerge, also after the Vatican Declaration of 21 December 2020. Again, these several statements repeatedly resonate the “gradation idea” (= only falling back on vaccines that contain an aborted cell line in the production and/or development phase, if no other options are available).Footnote 204

Even in the further course of 2021, the debate was still ongoing with, e.g., on 14 April 2021, Poland’s Episcopate bioethical team declaring that the use of the Oxford-AstraZeneca and the Johnson & Johnson Covid-19 vaccines raised “serious moral opposition”, because their technology is linked to lines of cells derived from aborted foetuses.Footnote 205

9.3.2 Medicines and Treatments for Covid-19

9.3.2.1 General

According to Fadel et al., given that there does not exist a real treatment for the Covid-19 disease, the basic clinical management of Covid-19 consists mainly of providing supportive care, supplemental oxygen and mechanical ventilatory support. Adjunctive therapy with immunomodulatory agents that target the inflammatory cytokine storm that may occur has also often been resorted to.Footnote 206

Since the emergence of Covid-19, several pharmaceuticals have been, or are being tested for safety and efficacy as possible treatments for Covid-19. These include corticosteroids, the antiviral nucleotide analogue “remdesivir”, systemic interferons and in particular interferon β-1a, monoclonal antibodies against components of the immune system, such as interleukin-6 (IL-6) and IL-4, other immune modulators and antibodies against components of SARS-CoV-2.

On its website, the Harvard Medical School gives an insightful overview mentioning most of these drugs. As we ourselves have, obviously, no medical expertise whatsoever, this overview, complemented by findings of other researchers and/or authors, has been used as a basis for the exploration of these medicines mentioned below, in full acknowledgment of the authorship of the researchers and institutions referred to in the footnotes.

9.3.2.2 Rest and Hydration

According to the Harvard Medical School, for people with Covid-19 who are recovering at home, the main medical advice is to get enough rest, although one does no not necessarily have to stay in bed. People with Covid-19 are also recommended to stay hydrated. To reduce fever and relieve pain, acetaminophen has been advised.Footnote 207

9.3.2.3 Antiviral Drugs

9.3.2.3.1 General

According to the Harvard Medical School, an antiviral drug should be able to address the part of a virus’ life cycle necessary for its reproduction. Moreover, an antiviral drug should be able to destroy a virus without killing the human cell the virus occupies. A specific problem is that viruses reproduce very rapidly, as a result of which they have many opportunities to mutate (= i.e., to change their genetic information) with each new generation (cf. Sect. 1.1.2). This implies that a virus may soon develop resistance to drugs or vaccines that before were still effective.Footnote 208

9.3.2.3.2 Ibuprofen and Acetaminophen

According to the Harvard Medical School, a variety of French doctors initially advised against the use of “ibuprofen” (e.g., Motrin, Advil, besides many generic versions) for treating Covid-19 symptoms. Said French doctors based their opinion on reports concerning otherwise healthy people who had contracted Covid-19 and had started taking an NSAID (short for a “non-steroidal anti-inflammatory drug”) to relieve their symptoms, and then developed serious illness, including pneumonia. However, said reports were only containing observations but were not the result of scientific research. The WHO itself initially recommended the use of “acetaminophen”, rather than “ibuprofen”, for helping to bring the fever and the pain associated with Covid-19 infection down. Later, the WHO changed its opinion and said that both “acetaminophen” and “ibuprofen” could be used. Due to this variety of cautionary opinions, some doctors remained concerned about NSAIDs. For this, it became a general guideline to choose using acetaminophen first, for a total dose that should not exceed 3000 milligrams per day.Footnote 209

9.3.2.3.3 Remdesivir

On 29 April 2020, data from a US National Institutes of Health (NIH) trial demonstrated that Remdesivir (a drug produced by the company “Gilead Sciences”) gave better results than a placebo for treating Covid-19. It, more in particular, had appeared that patients with advanced Covid-19 and lung involvement who had been given the antiviral had a 31% faster recovery time, amounting to about 4 days.Footnote 210 Shortly after these trial data were published, on 1 May 2020, the US FDA granted an EUA for using Remdesivir as a treatment against Covid-19.Footnote 211

On 22 October 2020, the FDA granted a full approval for using Remdesivir in order to treat Covid-19. The drug got approved to treat adults and children 12 years of age and older and weighing at least 88 pounds, provided they had been hospitalized with Covid-19. The FDA based its decision on the finding of clinical trials that had indicated that in these patients, Remdesivir could modestly speed up recovery time.Footnote 212 However, interim results appearing from the SOLIDARITY trial, an RCT—short for “randomized controlled trial”—that had compared four medicines with a control treatment in 405 hospitals in 30 countries, indicated that Remdesivir had had no effect on mortality in 2743 patients, compared with 2708 controls.Footnote 213

On 25 June 2020, the EMA’s Committee for human medicines (CHMP) recommended that Remdesivir would be granted a conditional marketing authorisation for the treatment of Covid-19 patients suffering from pneumonia and who are in need of supplemental oxygenation. On 3 July 2020, the European Commission acted on this recommendation by the EMA, by granting a conditional marketing authorisation to Remdesivir for the treatment of Covid-19 in adults and adolescents aged 12 years and above suffering from pneumonia and requiring supplemental oxygenation. At the same time, the EMA announced that it would continue to monitor the results of the SOLIDARITY trial. Meanwhile, the FDA itself issued a new warning against the use of Remdesivir in combination with hydroxychloroquine.Footnote 214

On 29 June 2020, Gilead Sciences set the price of Remdesivir at USD 520 per vial. With regard to the United States, this implied that for a 6-vial treatment, the typical treatment would be USD 3120 per patient for those with private insurance.Footnote 215

Critics of the price setting—such as the consumer group Patients for Affordable Drugs (abbreviated as “PAD”)—quickly pointed out that taxpayers’ money had been used for funding the trial from which the usefulness of Remdesivir for treating Vovid-19 had appeared through the National Institute of Allergy and Infectious Diseases.Footnote 216 PAD also referred to earlier government funding when the drug had in the past been tested for fighting Ebola.Footnote 217 Another group, the Pacific Business Group on Health, which represents employer concerns, similarly declared in a statement sent to The American Journal of Managed Care (abbreviated as “AJMC”) that it had “serious concerns” about the price, citing the ICER analysis and taxpayer-funded research support.Footnote 218 The group was quoted as saying:

It is another unfortunate example of drug manufacturers taking advantage of their monopolies to set prices at whatever level they want. It’s also a worrisome indicator that they will exploit the COVID pandemic to maximize their profits at the expense of patients. The bottom line is that this adds to the financial burden on employers and their employees and families, many of whom are already struggling from the impact of the COVID pandemic,” the group said.

By 24 August 2020, it appeared from a global, multi-centre study that Remdesivir showed little effect on patients hospitalised with Covid-19. The results of this study were published in JAMA and indicated that there were no significant differences with regard to the duration of the need for providing supplemental oxygen and of the hospitalization period itself between the intervention group that had been given Remdesivir and the control group that had only been provided with standard care.Footnote 219 When it granted full approval to the drug on 22 October 2020, the FDA did not mention the WHO trial in its assessment of the risks and benefits of Remdesivir for treating Covid-19, simply stating that an NIH-supported trial to support approval had been considered better for assessing recovery time than the WHO trial.Footnote 220

9.3.2.3.4 Baricitinib

In November 2020, the US FDA issued an EUA for the use of Baricitinib, in combination with Remdesivir, in Covid-19 hospitalised adults and children aged 2 years and older who are in need respiratory support. However, it was pointed out that there was not yet sufficient evidence to support the use of this treatment, instead of, e.g., dexamethasone, with or without remdesivir.Footnote 221

9.3.2.3.5 Lopinavir and Ritonavir

Lopinavir and ritonavir are antiretroviral drugs of the protease inhibitor class. They are usually used in combination to treat HIV infection.Footnote 222

From an RCT studying the use of lopinavir and ritonavir in 199 Covid-19 patients in China, it appeared that there had not been a statistically significant favourable effect on the clinical outcome or mortality in Covid-19 patients, compared to a control group of Covid-19 patients who had only received standard care. Similarly, the UK RECOVERY trial, which had enrolled 1616 Covid-19 patients on lopinavir-ritonavir and had compared the findings on these patients with the findings about 3424 other Covid-19 patients who had only been given standard care, did not identify any benefit of the use of lopinavir-ritonavir on survival, clinical course or duration of hospital stay of Covid-19 patients. However, it was pointed out that the study did not include a sufficient number of Covid-19 patients on invasive mechanical ventilation for allowing to study the effect of lopinavir-ritonavir in this category of patients. The reason why the latter group of Covid-19 patients had not been included in this study was that it had been too difficult to administer the drugs to these patients. The WHO SOLIDARITY trial had, in contrast, simply dropped the lopinavir-ritonavir arm of its research after an interim analysis of trial results.Footnote 223

9.3.2.4 Immunosuppressive/Anti-Inflammatory Drugs

Tocilizumab is an anti-inflammatory drug normally used to treat arthritis.Footnote 224

From the so-called “BACC Bay Tocilizumab trial”, i.e., a randomised, double-blind, placebo-controlled trial with regard to 243 Covid-19 patients in the United States, it appeared that tocilizumab had not been found effective for preventing intubation or death in moderately ill hospitalised patients suffering from Covid-19. However, on 19 November 2020, investigators that had conducted another RCT, entitled the REMAP-CAP trial, during a press release announced that the early analysis of the data of their trial pointed out that treatment with tocilizumab was effective in reducing death and the duration of time spent in intensive care in critically ill patients suffering from Covid-19.Footnote 225

More recent research has shown even more encouraging results about the use of the anti-inflammatory drugs tocilizumab and sarilumab. From a trial that run in six countries, including the United Kingdom, and that involved around 800 ICU patients, it appeared that these drugs reduced the number of Covid-19 related deaths from 36% to 27%. In a similar manner, it appeared from the RECOVERY study that tocilizumab enforced the life-saving effects of dexamethasone. From this research, it hence appeared that tocilizumab (and sarilumab) reduces inflammation, a symptom of Covid-19 that can flare up in Covid-19 patients and cause damage to a variety of organs, including the lungs. Based upon these studies, it was suggested that doctors could start administering tocilizumab and sarilumab to a Covid-19 patient who, although receiving dexamethasone, are still deteriorating and in need of intensive care.Footnote 226 According to said researchers, the combination of using tocilizumab and dexamethasone should reduce the risk of death by about one third for Covid-19 patients put on oxygen support and by half for patients put on ventilators.Footnote 227 However, the downside of this treatment is that it is not cheap, amounting to a cost price of around £500 per patient, in addition to the £5 price ticket for the dexamethasone treatment. But the benefits of using the drugs are clear—and involve a cost that is less than the cost per day of an ICU bed amounting to about £2000.Footnote 228

9.3.2.5 Corticosteroids

Around the world, many doctors, including in the United States, resorted to treating very sick Covid-19 patients with corticosteroids. This method has, moreover, been used since the early beginning of the Covid-19 pandemic. It is believed that such a treatment makes biological sense for Covid-19 patients who have developed a so-called “hyperimmune response” (also referred to as “a cytokine storm”) to the viral infection. In these cases, it is an overreaction to the Covid-19 virus of the immune system itself that starts damaging the patients’ organs, including the lungs, which may ultimately lead to the patient’s death. Dexamethasone and other corticosteroids (e.g., prednisone, methylprednisolone …) are powerful anti-inflammatory drugs. They have as further advantage that they are easily available and inexpensive. The NIH Covid-19 treatment guidelines, hence, started recommending the use of dexamethasone in selected Covid-19 patients hospitalised with severe Covid-19 illness.Footnote 229

9.3.2.6 Monoclonal Antibody Treatments

9.3.2.6.1 Overview

In the United States, three monoclonal antibody treatments for Covid-19 received an EUA from the FDA. All three treatments were allowed to be used to treat adults and outpatient children over 12 years of age who have tested positive for Covid-19 shortly before, who only show mild to moderate symptoms and who are at risk of developing more severe symptoms or of being hospitalised. This may include people over 65 years of age, obese people and people suffering from certain chronic diseases.Footnote 230

These monoclonal antibodies are man-made versions of antibodies that the human body naturally produces to fight invaders, such as the Covid-19 virus. All three FDA-approved monoclonal antibody treatments attack the spike protein of the Covid-19 virus, making it more difficult for the virus to attach and enter human cells. The three monoclonal antibody treatments that have received said EUA are “bamlanivimab”, manufactured by Eli Lilly; a combination of “casirivimab” and “imdevimab”, manufactured by Regeneron; and a combination of “bamlanivimab” and “etesevimab”, again manufactured by Eli Lilly.Footnote 231

Monoclonal antibody treatments must be administered intravenously in a clinic or hospital. However, these treatments have not been not approved for patients already hospitalised with Covid-19 or receiving oxygen therapy. They have not shown any benefit for these patients and could lead to more serious outcomes.Footnote 232

9.3.2.6.2 Regulatory Approvals

It was not until 23 June 2020 that researchers for the first time announced that they had discovered an antibody cocktail that uses antibodies directed at different parts of the spike that gives the Covid-19 virus its crown. The scientists found that the antibodies could be distinguished into two distinct groups, with each group targeting different regions of the viral spike. This made said researchers suggest that the battle against the Covid-19 virus should be fought on separate fronts, much like the one against HIV and some forms of cancer.Footnote 233

On 29 September 2020, Regeneron published the results of a study containing Phase I, II and III trials, still ongoing at the time, showing that its proposed monoclonal antibody treatment for Covid-19, entitled “REGN-COV2”,Footnote 234 was linked to several beneficial effects, amongst which quicker recovery, a reduced viral load, and the need for fewer medical visits.Footnote 235

On 9 October 2020, the Trump administration signed a USD 486 million agreement with AstraZeneca to develop an antibody treatment for Covid-19, which called for the HHS and the DOD to cooperate with the company for initiating the late-stage development and large-scale production of AstraZeneca’s own cocktail of two monoclonal antibodies, called AZD7442, which showed the potential to treat and/or prevent the Covid-19 disease.Footnote 236

On 9 November 2020, the FDA issued an EUA for Eli Lilly’s bamlanivimab.Footnote 237

On 23 November 2020, the FDA granted a EUA for the antibody treatment for dealing with Covid-19 that was made by Regeneron. This also concerned the antibody cocktail that had been administered to President Donald Trump when he was admitted to hospital during his battle against Covid-19 in early October 2020. (Cf., furthermore, Sect. 2.5.4.7.)Footnote 238

Almost six months later, on 6 May 2021, the newspaper The Guardian reported that three antibody drugs were under continuous review by the EMA: the above-mentioned Regeneron antibody combination, a similar Celltrion monoclonal antibody, and the monoclonal antibody cocktails from Eli Lilly, which were said to show evidence of reducing the risk of Covid-19 related hospitalization and death by 87%. While the Regeneron and Celltrion drugs had not yet been given marketing authorization, EU member states had been given permission by the EMA to use them on patients not requiring oxygen and at high risk of progressing to severe illness. An EMA review was also expected to start within days of a fourth antibody cocktail named Sotrovimab and produced by GlaxoSmithKline.Footnote 239

9.3.2.7 Convalescent Plasma

According to the Harvard Medical School, when people recover from Covid-19, their blood contains natural antibodies that their body has produced in order to fight the Covid-19 virus and help them recover from the disease. These antibodies can then be found in plasma, a component of the blood. Convalescent plasma—literally referring to plasma taken from the blood of recovered Covid-19 patients—has been used for more than a century already to treat a variety of diseases, ranging from measles and polio to chickenpox and SARS. Its safety has been widely recognised.Footnote 240

On 23 August 2020, the FDA issued an EUA with regard to the use of convalescent plasma in hospitalised patients suffering from Covid-19.Footnote 241

However, the donation of blood for retrieving convalescent plasma has in the United States been subjected to several severe criteria. Such a person donating blood must first have tested positive for Covid-19 himself. He must then have recovered and be symptom-free for 14 days. He must, moreover, be free of Covid-19 disease at the time of plasma collection. He must finally still have sufficiently high levels of antibodies in his blood plasma. In addition, the donor and the patient to whom the plasma will be administered must also have compatible blood types. Once plasma has been retracted, it will then be screened for other infectious diseases, such as HIV.Footnote 242 Plasma donation must not weaken the donor’s immune system or make him (or her) more susceptible to reinfection with the Covid-19 virus.Footnote 243

It has, furthermore, been indicated that each plasma donor produces enough plasma to treat one to three Covid-19 patients.Footnote 244

At the time of the announcement of the EUA, the treatment was still under debate, with some experts doubting whether all patient populations could benefit from the therapy, amongst others due to a purported lack of data on its effectiveness. Meanwhile, White House press secretary Kayleigh McEnany had referred to it as a therapeutic breakthrough.Footnote 245 The European Commission, in collaboration with the EU/EEA Member States, the European Blood Alliance (EBA), ECDC and other health professionals, similarly developed guidelines on the collection, testing, processing, storage, distribution and controlled use of convalescent plasma for the treatment of patients with Covid-19. The European Commission also set up an open-access EU/EEA database in order to collect data on CCP donations and patient outcomes after transfusions.Footnote 246

9.3.2.8 Steroids

By 3 September 2020, three studies reported that low-cost corticosteroids were the most effective treatment (at that date) for severe cases of Covid-19. From these studies, it had more precisely appeared that the use of systemic corticosteroids could reduce the risk of death in people hospitalised with Covid-19 by a third, compared to patients having received usual care or placebo only.Footnote 247

A steroid can be used as a drug to the extent that it may help reducing inflammation by mimicking the anti-inflammatory hormones produced by the body itself. The beneficial effect usually consists of dampening the body’s immune system.Footnote 248 A Covid-19 infection triggers inflammation as the body tries to fight the virus that causes the infection. But sometimes the human immune system may go in overdrive. This overdrive reaction can prove lethal, in which it ends up attacking the body’s own cells. Some steroids can calm this effect.Footnote 249

Steroids that, to some extent, have been shown effective against Covid-19 include (the already referred to) “dexamethasone” and “hydrocortisone”. It has, more precisely, appeared that these steroids may reduce the risk of death by a third for Covid-19 patients on ventilators, and a fifth for those on oxygen.Footnote 250

However, it has, furthermore, been pointed out that dexamethasone is only suitable for people already hospitalized with Covid-19 and put on oxygen or mechanical ventilation, in other words the sickest Covid-19 patients. In contrast, the drug does not seem work in people only showing milder symptoms of the Covid-19 infection, in which cases suppressing the immune system cannot be helpful.Footnote 251

Research has, furthermore, shown that with regard to Covid-19 patients on oxygen, steroid treatment could prevent one in five deaths.Footnote 252 Another advantage of steroid treatment is that it is cheap. Treatment with dexamethasone costs only about £5.40 per day per patient, with patients suffering from Covid-19 being in need of treatment for up to 10 days. The drug is, in addition, widely accessible. As it was first manufactured in 1957 and became available for use in the early 1960s, the drug has in most territories run out of patent protection. This implies that a wide variety of pharmaceutical enterprises can manufacture the drug.Footnote 253

9.3.2.9 Interferon Beta

In January 2021, some UK hospitals decided to launch a large-scale trial of a new treatmentFootnote 254 aimed at preventing patients suffering from Covid-19 from developing a serious illness. The new treatment involves inhaling a protein called “interferon beta”. This is a protein which the body itself produces when it has a viral infection. Hopes were that inhaling interferon beta would stimulate the immune system and prepare the cells to fight the Covid-19 virus.Footnote 255 Initial research results already have suggested that the treatment may help reducing the risk of a Covid-19 patient from being hospitalised and developing serious illness, which could itself increase the need of ventilation, by up to 80%.Footnote 256

In the course of 2020, there had already been conducted a Phase II clinical trial of the treatment, with promising results. From this Phase II clinical trial, it more in particular had appeared that, when receiving treatment with interferon beta, the chances of a Covid-19 patient of being hospitalised for Covid-19 treatment because of serious illness—e.g., in order to receive ventilation—were reduced by almost 80%. Moreover, patients who had received treatment with interferon beta had been two to three times more likely to recover to the point where their daily activities were no longer compromised by their illness. The Phase II trials had also found a very significant reduction in breathlessness among Covid-19 patients who had been given the treatment. Finally, the average duration of a hospital stay for Covid-19 patients who had been given the new drug, had been reduced by a third, from an average of 9 to 6 days.Footnote 257 However, the trial sample of this first study had been small, consisting of only 100 patients, so that further testing was considered necessary before interferon beta could be approved for use. This resulted into a new “phase III” trial, in which a much larger group of test subjects were participating. It was more specifically announced that this Phase III trial would involve over 600 patients in 20 countries. In addition, as had been the case in the previous Phase II trial, half of the participants to the Phase III would receive the drug, the other half a placebo. The new trial was due to finish early summer 2021. If the results would appear to be as good as those of the previous Phase II trial, it was expected that approval to use the drug in Covid-19 patients in the United Kingdom and other countries would follow shortly thereafter.Footnote 258

9.3.2.10 Hydroxychloroquine

9.3.2.10.1 The Science

Hydroxychloroquine is a drug that is mainly used for treating malaria, besides some other inflammatory diseases, including lupus and rheumatoid arthritis. The drug is inexpensive and readily available.Footnote 259

Initial reports stemming from China and France on the use of the drug to treat Covid-19 had been promising. These earlier reports had, more in particular, suggested that patients suffering from severe Covid-19 symptoms had improved more rapidly when given hydroxychloroquine.Footnote 260 However, in a paper that was published in JAMA December 2020, researchers, in contrast, reported that, in comparison to Covid-19 patients that had been given a placebo, hydroxychloroquine did not provide a clinical benefit to adults being hospitalised with Covid-19 respiratory disease. As a result, NIH treatment guidelines started to recommend against the use of hydroxychloroquine for treating Covid-19 in both inpatients and outpatients.Footnote 261

9.3.2.10.2 The Politics

Clearly, hydroxychloroquine has gotten famous because it was one of the (unproven) treatments for Covid-19 endorsed by President Donald Trump on numerous occasions. Since this clearly shows what the man is capable of, let us first see what he had to say about using hydroxychloroquine to treat Covid-19 in March-April 2020 by literally referring to his own words:Footnote 262

  1. (1)

    On 19 March 2020, Trump had for the first time announced that the FDA was on a fast-track of approving a number of unproven Covid-19 treatments, including hydroxychloroquine, which he said has “been around for a long time so we know if things don't go as planned it’s not going to kill anybody.”

  2. (2)

    On 20 March 2020, despite the fact that NIH Director Dr Fauci had declared that “the answer is no” upon having been asked if hydroxychloroquine is an effective Covid-19 treatment, Trump had still said “we ought to give it a try,” adding, “I feel good about it. That’s all it is, just a feeling, you know.”

  3. (3)

    On 21 March 2020, Trump had referred to a paper that had later been ripped apart by experts, when tweeting that “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine”. Trump had, moreover, also said that the drugs should be “put in use IMMEDIATELY. PEOPLE ARE DYING, MOVE FAST, and GOD BLESS EVERYONE!”

  4. (4)

    On 30 March 2020, after having pointed to a trial of hydroxychloroquine on Covid-19 patients in New York (from which it would appear that the drug was useless for treating patients suffering from the Covid-19 virus), Trump had said that the country would have a “good idea” if the drug was effective in “the next three days.”

  5. (5)

    On 3 April 2020, Trump had said the following: “Hydroxychloroquine, I don’t know. It’s looking like it’s having some good results. I hope. That would be a phenomenal thing.”

  6. (6)

    On 5 April 2020, Trump had said: “I’m not acting as a doctor, but there are some good signs,” and “We don’t have time to take a couple years and test it out, we have people dying today as we speak,” while also asserting “it doesn’t kill people.”

  7. (7)

    On 7 April 2020, it was revealed in the press that, on one hand, Trump had small and distant financial links to Sanofi, an enterprise that produces hydroxychloroquine,Footnote 263 and, on the other hand, that dark money groups had been pushing Trump to publicly support the drug.

  8. (8)

    On 14 April 2020, while having a meeting with recovered Covid-19 patients, some of whom were reported to have taken hydroxychloroquine, Trump praised the drug as “an unbelievable malaria pill. Unbelievable lupus pill”. Trump had, in addition, come up with the remarkable statement that, if a different president than himself would have been the one promoting the drug, “people would say, ‘Gee, isn’t that smart?’”

  9. (9)

    On 5 May 2020, Biomedical Advanced Research and Development Authority Director Rick Bright alleged that he had been demoted because of his resistance to Trump’s promotion of the unproven drug.

  10. (10)

    On 18 May 2020, after a period of silence that came after studies from which it had appeared that hydroxychloroquine is ineffective for treating Covid-19 and after the FDA had issued a warning against a too wide use of the drug, Trump surprised the public by stating that he himself had been taking hydroxychloroquine for “about a week and a half” with “zero symptoms,” furthermore reiterating “what do you have to lose?”, besides slamming a further VA (short for “the Department of Veteran Affairs”) research report that had indicated the drug as ineffective for treating Covid-19 as “very unscientific.”

  11. (11)

    On 19 May 2020, Trump felt a further need for defending his earlier promotion of the drug, saying that he “worked with doctors,” referring to the above-mentioned VA study as a “Trump enemy statement” and as a “false study”, and incorrectly denying the existence of an FDA warning against use of hydroxychloroquine for treating Covid-19 patients.

  12. (12)

    On 20 May 2020, Trump announced that he would be finishing his still ongoing hydroxychloroquine regimen in “a day or two.”

A few days after President Donald Trump had repeatedly proclaimed that the malaria drug hydroxychloroquine was suitable for preventing and treating Covid-19, it was reported that the number of medical prescriptions for the drug skyrocketed, in spite of the majority of the scientific evidence pointing out his error.Footnote 264

9.3.2.11 Medication for Blood Clots

It has been pointed out that practically all Covid-19 patients that require admittance to hospital for Covid-19 treatment, have to be administered medication to help prevent blood clots. Physicians usually prescribe low-dose heparin or enoxaparin. However, for some Covid-19 patients, e.g., those that have already formed blood clots or are at high risk of developing them, this does not suffice. These patients may need full doses of anticoagulants.Footnote 265

9.3.2.12 Vitamins

According to the Harvard Medical School, there is some evidence that suggests that vitamin D may help protect against contamination and severe symptoms of Covid-19. It has, more in particular, appeared that people with low levels of vitamin D may, in general, be more susceptible to upper respiratory tract infections. From a further meta-analysis, it in addition has appeared that people taking vitamin D supplements, particularly those who had low vitamin D levels, are less likely of developing acute respiratory tract infections than those who do not. It is believed that vitamin D may protect against Covid-19 in two ways. Firstly, it may help strengthen the body’s natural defences against viruses and bacteria in general. Secondly, it may help prevent an exaggerated inflammatory response to the Covid-19 virus itself, which has been shown to contribute to severe disease in some people contraction Covid-19.Footnote 266

Some critically ill patients suffering from Covid-19 have been treated with high doses of vitamin C administered intravenously. The hope was that administering vitamin C in such a manner would speed up patient’s recovery. However, there is no clear scientific evidence whatsoever that such a treatment could be effective for dealing with Covid-19 infection. It is, hence, in no way considered a standard part of treatment of Covid-19 patients. As regards prevention, there is also no clear evidence that taking vitamin C may help prevent contracting the Covid-19 virus.Footnote 267

9.3.3 Covid-19 Tests

9.3.3.1 General

According to Duncan, there are Covid-19 tests that test for current Covid-19 infection and Covid-19 tests that test for past Covid-19 infection. Based on this criterion, two main types of Covid-19 tests may be distinguished: diagnostic Covid-19 tests that look for active Covid-19 virus infection in bodily fluids such as mucus or saliva,Footnote 268 and blood tests that test for antibodies—evidence that the immune system of the body has already encountered the Covid-19 infection in the past.Footnote 269 Antibody tests are not used to diagnose a current Covid-19 infection.Footnote 270

The choice of the right test mainly depends on the purpose of the test, i.e. the reason for and circumstances of testing, e.g., to confirm (or deny) an active infection with Covid-19, to identify asymptomatic or pre-symptomatic people who may be transferring the Covid-19 virus, or to determine whether a person has ever had Covid-19. This at the same time implies that there does not exist a single testing approach that is suitable for all needs and for solving all problems.Footnote 271

9.3.3.2 Molecular tests: RNA—PCR

Molecular tests (also known as “RNA” or “PCR” tests) are usually considered the most sensitive for detecting active Covid-19 infection. The results of such molecular tests are usually very accurate. These tests are, moreover, especially recommended in case a person is suspected of having contracted Covid-19. These tests are also useful to meet a burden of proof for a variety of reasons, such as when a person needs to prove to an employer or a HEI that they are not infected with Covid-19 before returning to the working floor or to the classroom.Footnote 272

Molecular tests are also referred to as “PCR tests”, with “PCR” being short for “polymerase chain reaction”, a reference to the laboratory technique that is used for detecting the genetic material of the Covid-19 virus. The results of such a PCR test may be available within the time frame of a few minutes to several days or more, depending on whether the sample that is taken for testing is analysed on site or sent to an external laboratory.Footnote 273 In most cases, the test is taken at a health centre by a health professional who will collect a bit of mucus from a person’s nose or throat, by using a specialised swab. Nasopharyngeal swabs are hereby considered the gold standard for taking such a mucus sample.Footnote 274

Some molecular testing is based on using saliva, which people may find more comfortable. This is, e.g., the case with most home test kits that allow people to collect their own sample of mucus or saliva, and then send it to a laboratory for overnight analysis. The advantage of these home testing kits is that they are easy to use and less burdensome than the long-swabs tests usually resorted to in health facilities.Footnote 275

On 9 May 2020, the US FDA expanded the approval of saliva-based testing for detecting Covid-19 infection; an EUA for this purpose was granted to a test developed by Rutgers Clinical Genomics Laboratory. The test that had been developed by this company allows people who cannot visit an official testing centre, to be tested at home. The groups of people for whom such at-home testing may be relevant, include those who are at home because they are ill, quarantined or at high risk of Covid-19 infection due to age or co-morbidities.Footnote 276 The test developed by Rutgers Clinical Genomics Laboratory had, moreover, already before been cleared under a so-called “umbrella” EUA with regard to high-complexity molecular LDTs that had allowed for the use of self-collected saliva samples gathered through Spectrum Solutions LLC’s SDNA-1000 Saliva Collection Device.Footnote 277

On 15 August 2020, the FDA issued another specific EUA, this time for “SalivaDirect”, a test that had been developed by researchers at the Yale School of Public Health and that was considered to be less invasive than standard nasal swabs tests. The principle of the Yale test is that, based upon shorter waiting times that have no negative impact on the sensitivity of the test, laboratories can run 90 test samples which are collected in sterile containers, in less than 3 hours. The test has as further advantages that it is inexpensive and that it provides comparable results as tests based upon nasal swabs.Footnote 278

On 26 August 2020, the FDA granted another specific EUA for a portable rapid test for Covid-19 that provides test results in less than 15 min. This test was designed to be used in specific settings that may need having test results rapidly available, such as workplaces and schools.Footnote 279

9.3.3.3 Antigen Tests

Antigen(ic) tests look for a piece of the Covid-19 virus envelope, while molecular tests rather aim at detecting a nucleic acid (such as RNA) belonging to the Covid-19 virus.Footnote 280 Antigen tests are a type of diagnostic test also referred to as “rapid test”, because the turnaround time is much faster than an RNA test. The test is also cheaper to produce. Therefore, antigenic tests are often resorted to for screening large numbers of people at the same time, e.g., at airports and similar settings.Footnote 281

From the patient’s point of view, the antigen test works in much the same manner as a molecular test. The antigen test also starts with a health professional taking a mucus or saliva sample from the back of the nose or throat of the person to be tested. But instead of having to wait for testing results for days, an antigen test can lead to a result in an hour or less. If an antigen test provides a positive testing result, it is probably accurate. The problem with antigen tests however is that they are more likely to miss an active Covid-19 infection. This implies that in case a person tests negative while still experiencing Covid-19-like symptoms, it is advisable to order a molecular test anyway, in order to rule out a false negative provided by the antigen test.Footnote 282

9.3.3.4 Antibody Tests

Antibody tests (also referred to as “serology” or “blood” tests) look for antibodies against the Covid-19 virus.Footnote 283 The main disadvantage of a Covid-19 antibody test is that it cannot diagnose an active Covid-19 infection. Instead, it can only indicate whether a person has been infected with Covid-19 at some point in the past, even if this happened several months ago. Moreover, antibodies do not become detectable until at least a few days after the start of a Covid-19 infection, implying that the antibody tests are not useful for making a rapid Covid-19 diagnosis (even in people with symptoms).Footnote 284

Upon completion of this book, there were not yet FDA-approved home antibody tests available. In contrast, antibody tests have to be performed by a health care provider who will have to take a blood sample (through either a finger prick or a blood draw from a vein in the arm). The vast majority of such antibody tests are, therefore, performed in a central laboratory, while the test results may take a few days to process.Footnote 285 The accuracy of antibody tests varies depending on the test itself and on the moment of testing within the period of the Covid-19 infection.Footnote 286

Antibody testing is, in addition, not recommended until at least 14 days after the onset of the symptoms related to Covid-19. The reason for this caution is that when an antibody test is taken too early—while the patient’s immune system is still in the process of building up its defences—it may not give a sufficiently accurate result. Therefore, it can be advisory to conduct an antibody at the same time as a viral test, e.g., when a person is at an advanced stage of the Covid-19 disease. An antibody test can also help to confirm a diagnosis of multisystemic inflammatory syndrome in children, a condition that has been linked to Covid-19.Footnote 287

9.4 Vaccination Campaigns

9.4.1 General

When during the last months of 2020 the news broke that several of the Covid-19 vaccines were not only ready for use, but also relatively (e.g., the Oxford-AstraZeneca Covid-19 vaccine) to very (e.g., the Pfizer-BioNTech Covid-19 vaccine and the Moderna Covid-19 vaccine) effective, this raised great hope throughout the Western world that by the summer of 2021, most people would be vaccinated, with a prospect that society would start functioning—more or less—normal again.

For the average European, the months of January-March 2021 quickly tempered the initial enthusiasm: It soon appeared that the producers of the Covid-19 vaccines that were ready for use and had (at least temporary) been approved by the regulatory agencies of the Western countries in which they were to be deployed—more precisely (1) the Pfizer-BioNTech Covid-19 vaccine, (2) the Moderna Covid-19 vaccine, (3) the Oxford-AstraZeneca Covid-19 vaccine and, shortly after, (4) the Johnson & Johnson Covid-19 vaccine–, appeared to hardly make any deliveries to the EU member states, while at the same time, in various other countries, such as Israel, the United States, the United Kingdom, the United Arab Emirates and Chile, the vaccination campaigns appeared to make rapid progress.

This difference in treatment between the various countries can be traced back in large part to a completely failed European policy with regard to the procurement of the Covid-19 vaccines during the second half of 2020.

Once again it became clear how much more the EU is committed to the neoliberal principles that determine its functioning, including the classical EU austerity and the respect for public procurement rules (with its basic principle of haggling on prices), rather than looking out for the wellbeing of its citizens. The result of all these bad policy choices was disastrous: while several other Western or Western-oriented countries soon had a prospect of achieving group immunity by the summer of 2021,Footnote 288 the EU was not even at a 15%-vaccination threshold by Easter 2021. This had no cause other than a mismanagement at the top-level of the EU decision-making bodies and of the national governments of the EU member states that had blindly swallowed the EU lead. And EU citizens were once again the victims of the political games that the leading EU elite are so fond of playing.

As Maçães has phrased it:Footnote 289

With the arrival of the vaccines, state competition took a new form, but not a milder one: an ugly global race for enough doses in which the losers are denied a quick path out of the pandemic. Suddenly, the laggards from the previous iteration of the game seemed for the first time to be ahead. The United Kingdom was the first jurisdiction to approve the new vaccine and quickly pulled ahead of other large, advanced economies in the race to vaccinate its population, a rare pandemic success for the country.

The United States followed, with the European Union falling behind, but none could match the success of Israel. In just two weeks in December the state succeeded in vaccinating close to 20% of its citizens, leading the world by a very large measure and drawing on its origins as a tightly knit small nation fighting for survival. The country is now very close to the 70% mark that experts deem enough to put an end to infection growth.

Around the same time, the European vaccination policy was named a “complete fiasco” by none other than European Parliament member and former Belgian Prime Minister Guy Verhofstadt. (Cf., furthermore, Sect. 9.4.3.1) From this, it appeared that while most of the Covid-19 vaccines were produced in Europe, most of this production had been exported to non-European countries, where mass vaccinations had already been carried out, while the European population remained largely unserved. This imbalance between production and distribution was made even more aberrant, when considering that the development of the Covid-19 vaccines had been partly financed by European institutions.

As a result of this huge shortage of vaccines in the EU member states, vaccination campaigns in practically all European countries—except for the United Kingdom—were experiencing immense delays: Only a limited number of at-risk groups (especially the elderly residing in nursing homes), in addition to (some of) the staff of care institutions and (some of) the medical professionals had at the time Guy Verhofstadt formulated his criticism, been served with a Covid-19 vaccine.

The situation was even more perverse in light of the fact that the vaccines destined for export also turned out to be the highest-performing vaccines (notably the Pfizer-BioNtech Covid-19 vaccine and the Moderna Covid-19 vaccine, with an overall effectiveness of 95% and 94.5% respectively), while the EU had for its own use, to a large extent, opted for the much cheaper, but also less effective Oxford-AstraZeneca Covid-19 vaccine, with an (at the time) estimated effectiveness ranging between 60% to 80% according to a variety of sources contradicting each other on this matter.

The foregoing, manifest imbalance between local production and the unavailability for use on the EU market, already in the course of February 2021, inevitably caused fear that the Covid-19 pandemic on the European continent was to last much longer than in other territories, such as Israel, the United States and the United Kingdom. On a practical level, this implied that while some other Western countries were gradually achieving to have a sufficiently large part of their population vaccinated by the summer of 2021, most European countries were likely to lag several months behind.

In the following Sects. 9.4.2, 9.4.3 and 9.4.4, we shall look in more detail at the course of the Covid-19 vaccination campaigns in the United States, the EU and the United Kingdom, with special attention to examining what has gone wrong at the EU level with regard to the procurement of the Covid-19 vaccines.

9.4.2 Vaccination in the United States

9.4.2.1 December 2020: Successful Start of the American Vaccination Campaign (Notwithstanding a Vaccination Mistrust of a Substantial Part of the American Population)

By the end of December 2020, the United States started administering the first Covid-19 vaccines, notwithstanding the fact that misinformation and conspiracy theories pervaded a large part of the general public. Indeed, already in a survey dated October 2020, 25% of the respondents indicated that they would not get a Covid-19 vaccine when it would become available.Footnote 290 According to another source, this percentage may even have amounted to 40%.Footnote 291

Several causes for this vaccination reluctance among a large part of the American population have been suggested.Footnote 292

There is in the first place a large anti-vax community. These people are in principle opposed to vaccination, as in their opinion, no vaccine can ever be safe.Footnote 293

Secondly, there was a faction of the American population that hat started peddling conspiracy theories about the Covid-19 vaccines in particular. According to one such conspiracy theory, the Covid-19 diseased has been caused by 5G cell towers, implying that a vaccine would be useless against it. A second conspiracy theory holds that the vaccines are a plot by the Bill and Melinda Gates Foundation—or alternately, by Elon Musk—aimed at injecting microchips into the American people, and by extension into the world population (in order to gain planet domination, or to eradicate a part of humanity). The latter (absurd) theory even made Bill Gates himself respond.Footnote 294

However, most people in the vaccine hesitancy camp were said to have more rational objections, in most cases being worried enough not to want to be at the head of the line for a new vaccine. One such worry sounded that the vaccines had come about too quickly, raising doubt whether they had been tested in a sufficient manner. A similar concern was about the side effects of the vaccines (e.g., the allergic reaction “anaphylaxis”, or the partial facial paralysis “Bell’s palsy”, or blood clots), notwithstanding the fact that the odds of getting one of these side effects are extremely small.Footnote 295

Even demographics were reported to play a role. As with so much else that is going on in the United States, opinion on Covid-19 vaccination got to a large extent determined by political affiliation.Footnote 296 The Gallup organization which started tracking Covid-19 vaccine attitudes by alignment with a political party since July 2020, e.g., found that Democrats were consistently more willing of getting vaccinated for Covid-19 than Independents or Republicans.Footnote 297 Figure 9.3 presents a schematic representation of Americans’ willingness to be vaccinated for Covid-19 by political assignation, as measured in 2020.

Fig. 9.3
figure 3

Americans’ willingness to be vaccinated for Covid-19 by political assignation [Source: Brenan (2020)—Copyright © 2021 Gallup, Inc. All rights reserved. Reprinted with permission]

Age also appeared to play a role. With regard to this criterium, it appeared that willingness for receiving a Covid-19 vaccine generally tracked age-determined susceptibility to the Covid-19 disease itself.Footnote 298

But on no other criterium was the difference between willingness and unwillingness to receive a Covid-19 vaccine starker than on race and ethnicity. From one of the polls, it had, e.g., appeared that 83% of the in said poll surveyed Asian-Americans had indicated their intent to receive a Covid-19 vaccine, compared to 63% among those belonging to the Latinx community and 61% among White people. In Black American respondents, the numbers were said to completely “fall off the table”, with just 42% of surveyed Black Americans having declared their intent to be vaccinated.Footnote 299 Figure 9.4 gives a schematic representation of Americans’ willingness to be vaccinated against Covid-19, by subgroup, as measured in 2020.

Fig. 9.4
figure 4

Americans’ willingness to Be Vaccinated Against Covid-19, by subgroup [Source: Brenan (2020)—Copyright © 2021 Gallup, Inc. All rights reserved. Reprinted with permission] (Answering the question “If an FDA-approved vaccine to prevent coronavirus/COVID-19 was available right now at no cost, would you agree to be vaccinated?” - % Yes-answers)

Notwithstanding these objections of large groups of the American population, the vaccination campaign went ahead as of December 2020, starting with the administration of the at the time two (EUA) approved vaccines, namely the Pfizer-BioNTech and Moderna Covid-19 vaccines.Footnote 300

9.4.2.2 Progress of the Covid-19 Vaccination Campaign in February and March 2021

By February 2021, on average 1.6 million Covid-19 vaccine doses were administered on a daily basis.Footnote 301

Health workers were reported to have handed out 61.2 million doses of a Covid-19 vaccine between 20 January 2021—when Joe Biden had become the new American president—and 1 March 2021. That pace was reported to be high enough to beat Biden’s initial goal of 100 million Covid-19 vaccine shots during his first 100 days in office and was falling just shy of his revised goal of 150 million shots.Footnote 302 It was at the time also reported that the pace would even accelerate with the approval of a third Covid-19 vaccine from Johnson & Johnson.Footnote 303

As of 2 March 2021, the United States reported 28,403,416 Covid-19 cases, with a total of 513,071 Covid-19 related deaths. According to one source, by then, already 54,035,670 people had been given a first dose of a Covid-19 vaccine, which made President Joe Biden start expressing his hopes that the country would reach herd immunity by the summer of 2021.Footnote 304

By 3 March 2021, according to another source, around 80.5 million Covid-19 vaccine doses had been administered, with 15.9% of the population having received at least one dose of a Covid-19 vaccine.Footnote 305 This implied that at least 52.9 million Americans had received at least one dose of the Pfizer-BioNTech or Moderna Covid-19 vaccines. Overall, 27 million, or just under 8% of the American population, had been fully vaccinated. Alaska was in lead of all states, with 14% of its population fully vaccinated, while Utah ranked last with only 6% of its population fully vaccinated.Footnote 306 The vaccination effort was, moreover, reported to prioritize older Americans. As of 3 March 2021, 13.4 million people aged 75 and older, or 60% of everyone in this age group, had received at least a single Covid-19 vaccine dose. Additionally, 6.8 million, or 30% of the age group, had been fully vaccinated.Footnote 307

9.4.2.3 March 2021: President Joe Biden’s Further Vaccination Efforts

While in March 2021, in the Member States of the EU, due to lack of Covid-19 vaccine supplies, the vaccination campaign was suffering huge delays (cf. Sects. 9.4.3.1 and 9.4.3.2), in the United States, after the flying start as of the end of December 2020 and after Joe Biden had taken office as new president on 20 January 2021, the vaccination campaign accelerated even further.

From a press briefing of 10 March 2021, it appeared that the United States had just received more supplies of the Pfizer-BioNTech and Moderna’s Covid-19 vaccines, good for more than 20 million doses to be sent out to states, tribes, territories, and pharmacies. It was, furthermore, announced that the United States was on the verge of procuring an additional 100 million doses of the Johnson & Johnson Covid-19 vaccine.Footnote 308

By that date, the United States had purchased enough Covid-19 vaccine doses for serving every adult living in the country. In addition, approximately 75% of the Covid-19 vaccines that had already been distributed to states, had effectively been administered.Footnote 309 By the same date, more than 90 million Americans had received one or two jabs of a Covid-19 vaccine, with an estimated 61 million Americans having received at least one dose and an estimated 32 million Americans having been fully vaccinated.Footnote 310 The White House also reported that in the period between June 2020 and January 20, 2021, there had been a seven-day average of 890,000 Covid-19 vaccine shots per day. By 20 March 2021, the United States averaged above 2 million shots per day.Footnote 311

On the day President Joe Biden entered office, 8% of the American people over 65 had been inoculated for Covid-19. By 10 March 2021, that percentage had already risen to 60.Footnote 312 It was even reported that on 9 March 2021, Alaska became the first state to make the Covid-19 vaccines available to all people over the age of 16.Footnote 313

On Monday, 8 March 2021, the CDC for the first time issued guidance on social activities that fully vaccinated people would be able to safely resume, with limited risks for themselves and others. E.g., fully vaccinated people were allowed to meet other fully vaccinated people in small groups, without having to wear a face mask or without having to distance themselves from one another physically. Fully vaccinated people were also given permission to start visiting unvaccinated people belonging to another household, without wearing face masks or having to physically distance themselves, as long as no one in the unvaccinated household was at high risk of serious illness from Covid. Finally, fully vaccinated people did no longer need to be quarantined or tested after contact with a Covid-19 contaminated person, as long as the fully vaccinated person himself remained asymptotic after such a contact had taken place.Footnote 314

On 11 March 2021, President Joe Biden declared that he would urge states to make a Covid-19 vaccine available to all American adults by no later than 1 May 2021. The Biden administration had already previously indicated that the United States had acquired enough of the Covid-19 vaccines to inoculate every adult American citizen by the end of May 2021. By that time, the Biden administration had committed nearly USD 20 billion to the Covid-19 vaccine rollout programme, as part of the USD 1.9 trillion Covid-19 rescue package that the Biden administration had proposed in January 2021 and that had been signed into law by President Biden on 11 March 2021.Footnote 315

By 19 March 2021, more than 115 million doses of a Covid-19 vaccine had been administered throughout the United States, while the United States had managed to distribute more than 151 million Covid-19 vaccine doses.Footnote 316

On 23 March 2020, the rollout of the American Covid-19 vaccination campaign even gained further momentum. There were then, on average, more than 2 million doses of a Covid-19 vaccine administered on a daily basis. This was in part due to the increased supply of Covid-19 vaccines, resulting from the EUA that had been granted to the Johnson & Johnson Covid-19 vaccine, which helped accelerate the rollout on the basis of three EUA approved vaccines instead of two.Footnote 317 In the meantime, states remained the ones responsible for making the practical decisions about vaccine implementation, with most of them having defined eligibility to first include frontline laborers, such as those employed by the healthcare industry, and people aged 65 and over. A handful of states had already expanded eligibility to include people belonging to even younger age groupsFootnote 318

9.4.2.4 25 March 2021: New Vaccination Targets

On 25 March 2021, Joe Biden held his first official press conference as President of the United States.Footnote 319

During the press conference, President Biden announced his additional efforts to (1) further accelerate the US Covid-19 vaccination campaign, (2) ensure that all American individuals and communities would obtain access to a Covid-19 vaccine, and (3) especially expand access to the Covid-19 vaccines to the most affected and at-risk communities throughout the country. It was, furthermore, announced that, with funding largely provided under the American Rescue Plan (cf. Sect. 4.4.3), the US Department of Health and Human Services (HHS) would invest nearly USD 10 billion for increasing access to the Covid-19 vaccines and for ensuring a better distribution of the vaccines among communities of colour, rural areas, low-income populations and other underserved communities, as part of the federal Covid-19 response policy.Footnote 320

President Biden also highlighted that “equity”Footnote 321 was one of his top policy priorities. This included the setting up of federally run community-based Covid-19 vaccination centres in the most affected areas of the United States, sending Covid-19 vaccines directly to local pharmacies and community health centres that had to serve vulnerable population groups in a disproportionate manner, launching hundreds of mobile clinics in order to reach people where they are, and creating the “Covid-19 Health Equity Task Force”.Footnote 322

The announcements of 25 March 2021 included:Footnote 323

  1. (1)

    A USD 6 billion investment in community health centres for expanding access to the Covid-19 vaccines among underserved communities.

  2. (2)

    Extending eligibility for the Covid-19 vaccines to people served by community health centres.

  3. (3)

    An investment of USD 3 billion to build confidence in the Covid-19 vaccines.

  4. (4)

    The launching of a partnership for the Covid-19 vaccination of dialysis patients.

  5. (5)

    An investment of USD 330 million in community health workers.

As of 7 April 2021, a total of 225,294,435 Covid-19 vaccines had been delivered to the United States, of which 171,476,655 had been effectively administered. Table 9.3 provides an overview of the status of the Covid-19 vaccinations at that date.Footnote 324

Table 9.3 Number of vaccine doses administered on 7 April 2021a

By 2 May 2021, according to information provided by the CDC, the number of Americans fully vaccinated against Covid-19 exceeded 101 million. More than 43% of Americans had by then received at least one dose of a Covid-19 vaccine.Footnote 325

9.4.2.5 Biden’s Approval Rating in Mid-April 2021

By mid-April 2021, the rapid roll-out of the Covid-19 vaccination programme, together with the USD 1.9 billion Coronavirus relief programme (cf. Sect. 4.4.3), helped assure President Biden a high approval rating as he was approaching his 100th day in presidential office.Footnote 326

This appeared from a poll that had been organized by the Pew Research Center.

For its research, the Pew Research Center had surveyed 5109 American adults throughout April 2021. These were all members of the Pew Research Center’s American Trends Panel (ATP) and had been recruited to be representative of the general population by gender, race, ethnicity, party affiliation, education and other categories.Footnote 327

It resulted from this survey that President Joe Biden received the support of 59% of the people surveyed in the Pew study. The Pew Research Center also made a comparison of Joe Biden’s performance to that of other recent presidents with regard to their first days in the White House. From this comparison, it appeared that after 100 days in office of his first and only term as president, Donald Trump had an approval rating of just 39%. In contrast, twice-elected President Barack Obama had a 61% approval rating in the month of April after his first term instalment, while Obama’s immediate predecessor, President George W. Bush, was at 55%. Ronald Reagan had been the one with the highest approval rating at the same stage, more precisely at 67%.Footnote 328

According to the Pew study, while a new immigrant crisis on the US southern border manifested itself as a nearly test of Biden’s determination, the issue of illegal immigration had overtaken Covid-19 as the issue Americans considered “a very big problem”.Footnote 329

In the April 2021 Pew survey, a clear majority—more precisely consisting of 72% of the surveyed respondents—had rated the Biden administration’s Covid-19 vaccine rollout as “good” (43%) or “excellent” (29%). A majority of 67% of the surveyed respondents had, moreover, given their approval to Biden’s coronavirus aid programme, including 36% who had indicated it as “very good”.Footnote 330 Remarkably, the 72% presidential approval rating with regard to the federal Covid-19 vaccination programme included a majority of Republicans and Republican-leaning voters at age 55.Footnote 331 Still, deep partisan divisions remained over Biden’s ratings on a variety of other policy issues. A total of 81% of the Republicans, or those who lean Republican, generally disapproved of Biden’s overall presidency, while 93% of the Democrats or those who lean Democratic, generally approved. According to the Pew Research Center, this pointed to a wide partisan divide within the American society.Footnote 332

9.4.2.6 Vaccination of the US Health Sector

According to another survey,Footnote 333 released on 6 April 2021, at the beginning of March 2021, only just over half (52%) of the American frontline healthcare laborers indicated that they had been administered at least one dose of a Covid-19 vaccine, amongst which 42% who had received both doses. This implied that no less than 48% of the frontline laborers employed in the healthcare sector in the United States had not yet received a single dose of a Covid-19 vaccine. These numbers were considered astounding to the extent that healthcare laborers who had to deal with patients, including patients suffering from Covid-19, were among the highest priority groups for access to the Covid-19 vaccines.Footnote 334

According to the same survey, the majority of healthcare professionals employed in hospitals (66%) and outpatient clinics (64%) indicated that they had been administered a Covid-19 vaccine. These relatively high figures were in contrast to the far lower figures concerning healthcare laborers employed elsewhere. The percentages of healthcare laborers having been administered a Covid-19 vaccine employed elsewhere amounted to 52% for those working in doctors’ surgeries, to 50% for those employed in long-term nursing homes or assisted living facilities, and to only 26% for home healthcare laborers. Similarly, around seven in ten (68%) of healthcare laborers involved in everyday diagnosing and treating patients, such as (general-practice) physicians or nurses, indicated that they had been administered a Covid-19 vaccine, compared to only around four in ten of healthcare laborers involved in administrative tasks (44%) or in assisting with more practical patient care, such as bathing, feeding, cleaning, exercise, and housekeeping (37%).Footnote 335

There again appeared to be huge differences based upon race. Only 39% of black and 44% of Hispanic frontline healthcare laborers had indicated that they themselves had been administered a Covid-19 vaccine, compared to 57% of the white healthcare laborers. These figures were said to reflect the similar disparities in vaccine uptake rates based upon race among the national adult population of the United States.Footnote 336 (Cf. Sect. 9.4.2.1.)

From the survey, it appeared that worries about the safety and efficacy of the Covid-19 vaccines had been among the main factors for explaining why a lot of the American, frontline healthcare laborers had indicated not yet taking a Covid-19 vaccine. Of the 48% of healthcare laborers who had indicated not yet taking a Covid-19 vaccine, 82% had said that they were concerned about potential side effects of the vaccines. 81% had indicated that they considered that the Covid-19 vaccines were too new and that they wanted to wait and see how the vaccines would work for other people. In addition, about two-thirds (i.e., 65%) had indicated that they did not trust the American government for ensuring the safety and efficacy of the vaccines. It was thereby pointed out that these concerns of the unvaccinated healthcare laborers again mirrored those living among the general American population.Footnote 337

9.4.2.7 Prognosis on Herd Immunity

Notwithstanding the huge success of the US vaccination campaign in the period between December 2020 and April 2021, many scientists and experts, already soon after the US vaccination campaign had started, had issued warnings that the United States was not likely to reach group immunity in 2021, or perhaps not even in 2022. This was due to many reasons, including the high levels of vaccine hesitancy in the country, besides the fact that the Covid-19 virus was still globally widespread, which led to new variants (and to a fear that there would follow others).Footnote 338

According to Glenza, herd immunity rates change based on (1) how contagious a given virus is, (2) the efficacy of available vaccines, (3) the number of people who receive the vaccine, and (4) the propensity of the virus to evolve, (5) among other factors.Footnote 339

The virus that causes Covid-19 (or “Sars-CoV-2”), is subject to the same pressures as e.g., measles, albeit having a serious of elements playing in its advantage. First, a worldwide and ongoing circulation of the Covid-19 virus gives it millions of opportunities to mutate, evolve and eventually evade vaccine conferred immunity. Very high vaccination rates have been able to prevent this phenomenon in measles. That is why experts refer to the Covid-19 immunization campaign as “a race between vaccines and variants”, implying that the Covid-19 vaccines must be distributed and administered quickly enough in order to tamp down on variants. Otherwise, as explained by Glenza, a vaccine may become nothing more than a static solution to a moving target.Footnote 340

Further, the Covid-19 virus is still a novel virus. Unlike measles, scientists are uncertain how long immunity (provided by either earlier contamination or a Covid-19 vaccine) will last, though for natural immunity it could be as short as a few months. Therefore, already early 2021, many experts started believing that already vaccinated people will continue to need either boosters, or variant-specific vaccines, in the future.Footnote 341 (Cf. Sect. 9.3.1.5.)

A third factor is that even before more contagious “escape variants” of the Covid-19 virus were identified, such as the B.117 variant first discovered in the United Kingdom (cf. Sect. 1.1.2), the United States was still facing a very difficult task in achieving herd immunity, due to the fact that when the vaccination campaign had started, there was not yet a vaccine available for roughly 20% of the American population—notably children.Footnote 342 That is precisely why in May 2021, both Pfizer-BioNTech and Moderna applied for a EUA that would allow their vaccines to be used on children (cf. Sect. 9.3.1.3).

High levels of vaccine hesitancy and continued inequities in how the vaccines are distributed, could, furthermore, continue to contribute to localized outbreaks of the Covid-19 virus, especially in areas where inoculation rates are lower.Footnote 343

Health inequality was expected to amplify the impacts of vaccine hesitancy even more. Some conservative regions with the highest rates of vaccine hesitancy tended to have worse overall health, weaker public health infrastructure and higher overall levels of poverty and poor housing, which could make Covid-19 spread in this region even worse.Footnote 344 (On the further impact of these determinants of health inequality, cf., furthermore, Chap. 10.)

By May 2021, it was feared that the “new normal” was going to depend on where a person lives and how local officials would decide to implement or ignore public health measures.Footnote 345

9.4.3 The EU’s (initially) Failed Vaccination Strategy

9.4.3.1 A Wrong Sense of Solidarity as the Starting Point of the EU’s Failed Vaccination Strategy

Already in March 2020, the EU had reached the decision in principle to base the vaccination strategy of its Member States on a vague principle of (European) solidarity.

However, it would soon appear that the EU Commission’s strategy of joint vaccine procurement turned out to be disastrous, with national leaders of EU Member States soon afterwards starting to accuse the EU of having been too bureaucratic, too limiting to its members and simply too slow in procuring Covid-19 vaccines,Footnote 346 as a result of which, at a moment when several other Western countries were starting, at high speed, to vaccinate their respective populations, the EU Member States did not yet have access to a supply of the Covid-19 vaccines that would have allowed for the vaccination of only their risks groups. Hence, while from January to March 2021, several other countries, such as Israel, the United States, the United Kingdom, Saudi-Arabia and Chile, were very successful in deploying their vaccination strategies, in EU countries, the population remained confronted with continued severe lockdown measures due to a third wave of the Covid-19 pandemic (cf. Sect. 2.4.3), besides with a shortage of vaccines.

As already mentioned before (cf. Sect. 9.4.1), this even made none other than European Parliament member Guy Verhofstadt, at the end of February 2021, sound the alarm bell through an emotional outcry which he shared in a video posted on his Facebook page. According to the information that Guy Verhofstadt shared, while (about) 75% of the world’s production of vaccines against the Covid-19 virus took place in Europe, only 4% to 6% of European citizens had received their first shot of a Covid-19 vaccination. It appeared that, even though Europe was the world leader in the production of the Covid-19 vaccines, there was an acute shortage of vaccines in almost every European country (the United Kingdom that had just before left the EU, excepted), resulting in a huge vaccination backlog. By contrast, several non-European countries had mass access to the most performing Covid-19 vaccines. E.g., according to press reports, by the end of February 2021, Israel had already been administering a Covid-19 vaccine to large parts of its adult population. In the United States, around 20% of the population had already been vaccinated, and in the United Kingdom almost 30%. In the United States, the Covid-19 vaccination coverage achieved was, moreover, (almost) entirely based on the two (at the time) best performing vaccines, namely the Pfizer-BioNTech and Moderna Covid-19 vaccines. On 26 February 2021, the US press even reported that, on a single day, no less than 2.2 million vaccinations had been administered throughout the United States.Footnote 347

Hence, as so many of the EU’s neoliberal policies (such as, before in history, the liberalization of the banking market and the energy market in the 1990s, which had turned out to be advantageous for big market players, but disastrous for the general consumer’s interestsFootnote 348), also its Covid-19 vaccination strategy turned out to be a disaster. More specifically, the EUs decisions to (1) prioritize process and price over reasonable progress, and to (2) put a purported form of “solidarity” between EU countries ahead of giving individual governments sufficient room to manoeuvre, would turn out to hold back an adequate Covid-19 response throughout the EU’s Member States during the first months of 2021. As a result, the EU vaccination strategy that was supposed to be a powerful demonstration of European solidarity, an affirmation of the EU single market’s purchasing power and an ethical stand against the by US President Donald initiated “vaccine nationalism”, soon resulted in a rollout that would leave the EU lagging far behind more successful countries such as Israel, Saudi-Arabia, the United Kingdom and the United States,Footnote 349 and that would be described by even some of the EU’s leading politicians themselves as an utter fiasco.

As a result of a number of poor EU policy decisions regarding the procurement of the Covid-19 vaccines, EU countries thus simply stood by when, already at the end of December 2020, the United States and the United Kingdom bought, approved, and started injecting Covid-19 vaccines at a high tempo. Under the rhetoric of having agreed upon on lower prices and a purported higher accountability for drug makers, next to ensuring shots for the whole of the EU, European delays in delivery only caused tensions among EU member countries resentful about the trade-offs, while the European population was throughout Q1 2021 completely left in the dark on the questions if and when they would ever get access to a Covid-19 vaccine jab.Footnote 350

The emergence of this—in the words of Guy Verhofstadt—“disastrous” take off of the European vaccination strategy as of the end of December 2020, moreover, came hardly as a surprise. On the contrary, during the entire first year of the global Covid-19 vaccine race, the EU had continuously been one or more steps behind: its move to start securing vaccine Covid-19 vaccine doses for itself came only after warnings that the United States had already started monopolizing production output. Its deliberative approaches to regulatory approval would leave EU citizens lagging behind the United States and the United Kingdom when it came to getting access to the Covid-19 vaccines—at a moment when delays were counting in lost lives.Footnote 351 As the EU shamefully discovered, wielding the market power and moral authority of 27 sovereign nations—with different budgets and perspectives on risk—, while at the same time complying with neoliberal policy principles (such as “austerity”) and technical procedures (such as the “public procurement” procedure), implied moving far more slowly than the one-and-done competition.Footnote 352

9.4.3.2 March-May 2020: Choosing Prestige Over Common Sense and Efficiency

The EU’s decision of deploying a joint vaccine procurement strategy, purportedly, started when the EU leadership began realizing that then US President Donald Trump and his coronavirus task force were already in March 2020 sitting together with a group of pharmaceutical executives in order to secure US access to the Covid-19 vaccine candidates which, at the time, were not even ready yet.Footnote 353

This would result in a new policy deployed by the EU Commission to start working together to inoculate not just citizens in every EU country, but the entire world.Footnote 354 Solidarity was thereby not only expected of EU member states regarding one another, but towards the entire world. This was a noble vision, but in light of the monopoly positions of the vaccine-producing enterprises rather naïve. This would, moreover, but a year later prove to be yet one more lost gamble with the lives of the European population.

As a result of the foregoing, instead on starting to secure Covid-19 vaccine candidates in progress, shortly after US President Donald Trump had announced a freeze on the US funding of the WHO, the Commission von der Leyen instead hosted a big fundraiser campaign. This campaign took place on the initiative of the EU, together with the UN and other big philanthropy players, on 4 May 2020, and would ultimately garner almost USD 8 billion, loosely earmarked for research on treatments and tests of Covid-19 vaccine candidates.Footnote 355 However, the USD 8 billion would be spent without any guarantee that the EU itself would benefit from its generosity in getting priority access to the Covid-19 vaccines, when ready.

This policy approach, not hindered by much insight on how the private pharmaceutical market in practice functions, regretfully implied that, rather than taking the immediate health interests of the European population at heart, the EU Commission purportedly noble goals in the end would prove to be fatal for getting quick access to the Covid-19 vaccines, when ready.

The United States itself wisely abstained from participating in the prestigious event. Instead, on 15 May 2020, President Trump formally launched his USD 10 billion “Operation Warp Speed”. The goal of this programme of the Trump administration was to invest in experimental Covid-19 vaccine candidates and to make their development speedily enough in order to be able to deliver 300 million doses to the American people by January 2021.Footnote 356 This strategy of the Trump administration would less than a year later prove highly beneficial for Trump’s successor, President Joe Biden who, as a result, immediately after entering the presidential office in January 2021, could continue the by then already initiated American vaccination program by having a seemingly monopolized access to the two most performant Covid-19 vaccines, namely the Pfizer-BioNTech and the Moderna Covid-19 vaccines which were by then ready for use. (Cf. Sect. 9.3.1.3.)

9.4.3.3 June 2020: The EU’s New Vaccine Strategy—Choosing Stinginess Over Human Lives and Economic Sense

In May 2020, the vaccination race was just beginningFootnote 357 and it should have been clear already then that, as far as a speedy access to the Covid-19 vaccines was concerned, the bets were far more on Trump’s business-driven sense of reality, than on von der Leyen’s idealistic yet unworldly attitude.

Already before, when it came down to securing medical supplies during the early months of the Covid-19 pandemic, the EU had not acquired a great track record. On the contrary, during the early days of the Covid-19 crisis, EU countries had unilaterally closed their borders and accused each other of hoarding precious personal protective equipment (PPE), so that it did not reach the places where it was most needed. (Cf. Sects. 2.3 and 2.4) Brussels’ response had been the deployment of a system meant to wield the purchasing power of 37 countries—the EU27 and 10 of their neighbours—for buying face masks and ventilators, besides a variety of medical equipment, which in part helps explain why these remained unavailable for the common European during the entire first months of the Covid-19 pandemic (except for buying face masks themselves on the private market at extremely high prices).Footnote 358 One of the main problems in all of this had been EU bureaucracy itself. E.g., before it could place an order, the EU Commission had to wait for each EU country to sign the purchasing agreement. Some countries, fed up with the endless back and forth, thus simply went ahead and purchased medical items on their own.Footnote 359

The same strategy was initially deployed as part of the EU’s vaccination program, which turned out to be just as disastrous.Footnote 360

What the EU especially underestimated was that its bureaucratic logic was no match for the working principles of the private, pharmaceutical market (although the neoliberal set-up of the latter had, to a large extent, been made possible thanks to the free market reforms of the EU itself; cf. Sect. 9.2). Thus, vaccine procurement presented a formidable challenge, with EU bureaucracy having to deal with a bewildering array of Covid-19 vaccine producing candidates, including pharmaceutical enterprises—all driven by the pursuit of profits, and none of which had yet produced a deliverable end product.Footnote 361

Meanwhile, some EU countries had decided to stop waiting for the EU Commission to strike a deal. E.g., France and Germany initiated talks with Moderna separately. By mid-April 2020, Paris and Berlin were even reported working together on a bilateral basis for buying Covid-19 vaccines.Footnote 362

Eventually, after having regrouped the EU27 Member States, the EU27 health ministers signed off on a EU Commission plan to buy the Covid-19 vaccines on their behalf, on 12 June 2020.Footnote 363

In parallel, the separate Franco-German initiative continued to make progress and had invited both The Netherlands and Italy to join its select buyers’ club. This initiative proved relatively successful, as by 13 June 2020 the “quartet”—also known as the “Inclusive Vaccine Alliance”—announced that it had reached an agreement for 300–400 million doses of the Oxford-AstraZeneca Covid-19 vaccine.Footnote 364 However, some small EU countries saw this elect initiative as a threat.Footnote 365 E.g., the then Belgian Health Minister Maggie De Block denounced the deal between the Vaccine Alliance and Oxford-AstraZeneca as the result of an “unreasonable” decision that would hurt everyone.Footnote 366

Shortly before, on 1 June 2020, Health Commissioner Stella Kyriakides had presented what could be called the “new EU vaccine plan”. Rather than continuing negotiations with vaccine producers by going back and forth to get approvals from each individual EU country, the European Commission came up with the idea of reusing a mechanism called the “Emergency Support Instrument”. This concerned a very rarely used tool that would allow Brussels to buy Covid-19 vaccines directly and without a further need of signatures from the individual EU Member States, for an initial amount of EUR 2.1 billion. Once approved by the central EU authorities, the Covid-19 vaccines would then be distributed among the EU countries in accordance with the size of their population.Footnote 367 In addition, the von der Leyen Commission also strengthened the firepower of “DG SANTE”, an until then relatively low-profile EU procurement service that had little real authority, but that would be granted the responsibility for the actual negotiations with drug and vaccine producing enterprises.Footnote 368

After the plan was approved by all 27 EU member countries, the four countries belonging to the Vaccine Alliance decided to close shop, allowing the European Commission to resume its own exclusive negotiations with “Johnson & Johnson” and “Oxford-AstraZeneca”, two producers of Covid-19 vaccines that would ultimately prove less effective than the Pfizer-BioNTech and Moderna Covid-19 vaccines that the European Commission initially neglected, but on which the United States was focusing.Footnote 369

The strategy for implementing the new Covid-19 vaccine plan was that, rather than one drug producing enterprise negotiating with 27 governments, the EU would wield its full market power, leaving drug producers in the dark about what terms were being agreed to with their competitors.Footnote 370 This new strategy, as conceived by the EU Commission, was even made public in a “Communication from the Commission” of 17 June 2020. This communication was named “EU Strategy for COVID-19 vaccines” (COM/2020/245 final)Footnote 371 and stressed the importance of a both global and European solidarity:

This is not only a European challenge, it is also a global one. All regions of the world are affected. The spread of the virus has shown that no region is safe until the virus is under control everywhere. In addition to it being in their clear self-interest to do so, high-income countries have a responsibility to accelerate the development and production of a safe and effective vaccine and make it accessible for all the regions of the world. The EU recognises this task as its responsibility.

To this end, the EU is leading the global effort for universal testing, treatment and vaccination by mobilising resources through international pledging and by joining forces with countries and global health organisations through the Access to Covid-19 Tools (ACT) Accelerator collaborative framework. The Commission will continue to support this global mobilisation and collaboration.

As part of the effort to help protect people everywhere and EU citizens in particular, the Commission is proposing an EU strategy to accelerate the development, manufacturing, and deployment of vaccines against COVID-19.

The strategy has the following objectives:

  • Ensuring the quality, safety and efficacy of vaccines.

  • Securing timely access to vaccines for Member States and their population while leading the global solidarity effort.

  • Ensuring equitable access for all in the EU to an affordable vaccine as early as possible.

The strategy rests on two pillars:

  • Securing sufficient production of vaccines in the EU and thereby sufficient supplies for its Member States through Advance Purchase Agreements (APAs) with vaccine producers via the Emergency Support Instrument (ESI). Additional financing and other forms of support can be made available on top of such agreements.

  • Adapting the EU’s regulatory framework to the current urgency and making use of existing regulatory flexibility to accelerate the development, authorisation and availability of vaccines while maintaining the standards for vaccine quality, safety and efficacy.

With regard to the joint purchasing strategy, the EU Commission’s approach was made crystal-clear:Footnote 372

Joint action at EU level is the surest, quickest and most efficient way of achieving that objective. No Member State on its own has the capacity to secure the investment in developing and producing a sufficient number of vaccines. A common strategy allows better hedging of bets, sharing of risks and pooling investments to achieve economies of scale, scope and speed.

An important step towards joint action between Member States has already been taken in the formation of an inclusive vaccine Alliance by France, Germany, Italy, and the Netherlands. This alliance was formed to pool the national resources of those countries and secure fair access to vaccine supplies for the European population. The current proposal builds on the important groundwork undertaken by that Alliance.

In order to scale this approach up to cover the whole EU, the Commission proposes to run a central procurement process, which creates a number of important advantages. In particular, all EU Member States will be able to benefit from an option to purchase vaccines via a single procurement action. This process also offers vaccine producers a significantly simplified negotiation process with a single point of contact, thus reducing costs for all. Centralising vaccine procurement at EU level has the merit of speed and efficiency by comparison with 27 separate processes. A truly European approach would avoid competition between Member States. It creates solidarity between all Member States, irrespective of the size of their population and their purchasing power. A pan-EU approach will increase the EU’s leverage when negotiating with industry. It will also enable us to combine the scientific and regulatory expertise of the Commission and the Member States.

A common EU approach will always respect the principle of subsidiarity and Member States’ competences in health policy: vaccination policies remain in the hands of Member States.

In other words, at a moment in time when US President Donald Trump, as befitting to a conniving businessman, had already concluded far-reaching agreements with several of the Covid-19 vaccine candidate developing enterprises, the EU itself was still mainly in its usual rhetoric phase, without yet any concrete action to improve the health and safety of its citizens.

All of the above would prove not to be of much help in securing a fast access to the Covid-19 vaccines, rather on the contrary, although the importance of proceeding fast had at the same time been explicitly recognized in the Commission communication of 17 June 2020, which stated:Footnote 373

Against that background, it is essential that all 27 EU Member States have access to a vaccine as early as possible. The same applies to the Member States of the European Economic Area (EEA).

The practical leadership of the EU-wide Covid-19 vaccine purchases was then entrusted to EU director-general for health policy Sandra Gallina, a former Italian translator.Footnote 374 In the Covid-19 vaccine negotiations on behalf of the EU, EU bureaucrat Gallina and her team would soon start putting great importance on three things: (1) a wide selection of potential vaccines, (2) low prices per dose, and (3) the principle that drug makers would bear legal responsibility if anything went wrong.Footnote 375 This approach was, moreover, in line with the guidelines that the EU Commission itself had put forward in its June 17, 2020 communication:Footnote 376

The aim of the negotiations is to conclude Advance Purchase Agreements with individual companies under the best possible conditions. These APAs will specify a number of details with respect to expected payments (such as payment amounts, schedule and financial structure), delivery details of the vaccine if and when successful (such as price per person vaccinated, quantity of vaccines and delivery timeline after approval) and any other relevant conditions (such as production capacity in the EU, possible availability of production facilities for the manufacturing of other vaccines or medicines in case of failure, or liability arrangements).

A speedy conclusion of procurement contracts was not the top priority of the Gallina task force; neither was securing quick delivery of the Covid-19 vaccines as of the respective dates on which they would, eventually, be ready. This, notwithstanding the communication of the EU commission of 17 June 2020 had explicitly mentioned otherwise.Footnote 377

The EU, moreover, mainly went after the cheaper vaccines, notably the Oxford-AstraZeneca and Johnson & Johnson Covid-19 vaccines, as opposed to the more expensive mRNA vaccines developed by BioNTEch-Pfizer and Moderna, and this notwithstanding the fact that the latter had a much higher effectiveness.Footnote 378

Precisely this stinginess later motivated the pharmaceutical enterprises to give priority to countries that had been willing to pay a higher price for the (more performant) mRNA vaccines (such as Israel and the United States). Perhaps even more ironic has been the fact that, while the EU had announced that its procurement policy emphasized concerns about vaccine quality and safety, including related liabilities to be granted by the Covid-19 vaccine producers, the EU would, ultimately, bet mostly on purchasing the two Covid-19 vaccines—notably the Oxford-AstraZeneca and Johnson & Johnson ones—that would cause the most problems with side effects, e.g., due to blood clots, from March 2021 on. (Cf. Sect. 9.3.1.4) In fact, when the latter problems surfaced in March-April 2021, the EMA would consistently downsize these problems, proclaiming that the risks posed by the Oxford-AstraZeneca and Johnson & Johnson Covid-19 vaccines did not outweigh the benefits of their continued use in the EU vaccination campaign. There was, in other words, by April 2021, not much left of the earlier concerns about product liabilities, unless in the form of meaningless EMA recommendations that the possibility of side effects should be mentioned on the package inserts of both vaccines. These were of course hardly read by anyone, to the extent that most of the vaccinations in EU Member States were administered by doctors or nurses, either in hospitals, home practices or vaccination centres, of course without the administrators of the vaccines making their packaging available to the vaccinees, let alone offering the rows of vaccinees standing in line to get a jab, the opportunity to first attentively read said package inserts.

In the period January-April 2021, delivery problems with the cheaper Oxford-AstraZeneca and Johnsons & Johnson Covid-19 vaccines, would result into immense delays of the EU vaccination campaign, even to the extent that the EU was afterwards forced to initiate court proceedings against AstraZeneca for breach of contract with regard to the performance of its delivery obligations. (Cf. Sect. 9.4.3.10.)

The failure of European bureaucracy in swiftly procuring enough Covid-19 vaccines would thus appear from two main levels, on the one hand, from a complete unfamiliarity with the working methods of the pharmaceutical sector and, on the other, from a very naive view on how the economy functions by assuming that small savings on the price of the (cheap) Covid-19 vaccines would ever be able to outweigh the damages that the European economy continued to suffer due to the delays in vaccinations.Footnote 379

Be this as it may, the EU Commission’s negotiations with the producers of the more efficient mRNA vaccines kept dragging on. Apparently, Covid-19—and the many lives it costs, next to the detrimental economic impact of the continued lockdown measures throughout the EU—did not lend any sense of urgency to the negotiation talks of the EU bureaucrats who, moreover, felt no need of making sure that the EU would have sufficient access to the more efficient mRNA vaccines as well. All negotiation talks were, furthermore, held virtually, adding an intangible complication to the whole ordeal.Footnote 380

Because of these factors, talks with Pfizer-BioNTech and Moderna, proved especially thornyFootnote 381 (as a result of which, by January 2021, the mRNA vaccines would hardly be accessible in the EU countries who, since then, saw it necessary to try and explain to their population that the much cheaper Oxford-AstraZeneca and Johnson & Johnson-vaccines were more than good enough for European use, notwithstanding a wide variety of concerns about their safety and side-effects).Footnote 382

9.4.3.4 Being the Last in Entering Into Contracts with the mRNA-Vaccine Producers, But Still Being Proud of It

When BioNTech-Pfizer had reported efficacy results of their Covid-19 vaccine higher than 90 percent on 9 November 2020 (cf. Sect. 9.3.1.3), and, moreover, promised to soon send their available testing and trial data to the European regulators, the EU Commission projected calm. Next, Moderna had reported efficacy rates higher than 90 percent on 16 November 2020 (cf. Sect. 9.3.1.3). In response, the United Kingdom made a deal with Moderna on that same day. But again, the EU Commission’s Gallina task force showed no urgency to speed up its negotiation processes.Footnote 383

On 17 November 2020, it seems that the US biotech company Moderna had lost its patience, when it had deemed it necessary to warn the EU countries that further dragging out negotiations to purchase its very promising Covid-19 vaccine, would ultimately slow down deliveries, and that, to the extent that several other countries had already signed deals, the latter were (obviously) bound to get priority. At the time, Moderna had just announced that its experimental mRNA Covid-19 vaccine promised to be almost 95% effective in protecting people from Covid-19, thus further boosting hopes of an end to the Covid-19 pandemic, only shortly after Pfizer-BioNTech had released similar promising findings about their own Covid-19 vaccine a while before (cf. Sect. 9.3.1.3). Moderna, furthermore, explained that while already since the summer of 2020, it had engaged in fierce discussions with the EU Commission about the EU buying 80 million doses of its Covid-19 vaccine, still no contract had been signed by 17 November 2020. In the meantime, Moderna had already signed agreements to provide its Covid-19 vaccine to Canada, Japan, Israel, Qatar and the United Kingdom. Moderna thereby pointed out that there was a lot of red tape involved in getting a deal with the EU, while, by contrast, it took just two weeks to cement a deal on providing the vaccine to Canada from the time the two sides had started talks to the signing of a contract.Footnote 384 Already then, it became clear that the EU would not be among the first to receive the Moderna Covid-19 vaccine deliveries when it would ultimately be ready, after having obtained the necessary regulatory approvals).Footnote 385

At the same time, also the United States had been showing far more eagerness to make a deal with Moderna. As explained before (cf. Sect. 9.4.3.2), already on 2 March 2020, Moderna and other Big Pharma executives had been meeting in The White House with (then) US President Donald Trump. By April 2020, the United States had already paid USD 500 million to bankroll Moderna’s clinical trials. Moderna received, on the whole, USD 2.5 billion in US government financial support under the notorious “Operation Warp Speed”, the initiative that the Trump administration had unveiled on 15 May 2020, to establish a close cooperation between the US federal government and the vaccine industry for developing a vaccine that would put a stop the Covid-19 pandemic. While for Moderna, Operation Warp Speed had proven to be one of the most efficient forms of support in the development of its Covid-19 vaccine, the EU from its side had merely committed to a lot of idle talk.Footnote 386

The result of all this was that, the United States would be able to start using the Moderna Covid-19 vaccine by the end of 2020, while the EU had not yet shown a concrete willingness to place an order.Footnote 387

Eventually, the purchase agreement between the EU and Moderna would get signed on 25 November 2020.Footnote 388 At that moment, most of the other (non-EU) Western countries had already weeks before signed their own Moderna purchasing contracts. As Moderna had already pointed out on 17 November 2020, the consequence of this would be that the EU would be the last to receive Moderna-deliveries, which helps to explain the slow start of the Covid-19 vaccinations in the EU member countries as of January 2020, while in many other Western countries, millions of doses of the Covid-19 vaccines had been administered already.

Moreover, the EU was similarly late in purchasing the BioNTech-Pfizer Covid-19 vaccine which was also purchased in November 2020. Again, the United Kingdom had acted more quickly, having bought its BioNTech-Pfizer Covid-19 vaccine supplies already in July 2020. Pfizer had offered the EU 500 million doses in the same month, but Brussels had simply turned the proposal down, deeming it too expensive.Footnote 389

As a result of all this, the United Kingdom had also reached a basic “deal in principle” with AstraZeneca 3 months earlier than the EU, and its later purchasing contract itself came with sharper teeth, although the EU would later keep stressing that it had signed its actual purchasing agreement a bit earlier than the United Kingdom (namely on 27 August 2020, while the UK’s actual purchasing agreement with AstraZeneca was dated on 28 August 2020—one day after the EU agreement).Footnote 390

The EU, hence, took in some cases months longer than the United Kingdom and the United States to sign purchasing agreements with the Covid-19 vaccine producers. Making matters even worse, the EMA, a body by definition particularly receptive to the precautionary principle that plays such a dominant role in EU policy-making, would later also take its time to approve the first vaccines. Its first approval bioNTEch-Pfizer Covid-19 vaccine came some weeks after the one granted by the United Kingdom, and ten days after the one granted by the United States.Footnote 391

According to Nicolas Bouzou, head of a Paris-based advisory firm called “Asterès”, the EU had simply made its orders too late and only focused on price, seemingly considering that getting access to the Covid-19 vaccines was not a priority. For Bruno Maçães, a political scientist at Washington DC’s Hudson Institute and former Portuguese secretary of European affairs, there was in the summer of 2020 simply “no sense of urgency” at the side the EU.Footnote 392

Maçães expressed this concern as follows:Footnote 393

There is a lot that went wrong with the European Commission’s vaccination strategy. But before everything else, there was complacency. Back in the summer, the predominant feeling in Brussels and many European capitals was that the virus could be controlled through savvy policy measures. The contrast with the health calamity in the United States made European officials forget that the pandemic was in fact a state of emergency requiring a decisive approach to vaccination. Instead, most believed that vaccines would eventually be needed to root out the problem, but the process could be conducted against the background of a waning pandemic, at least in Europe. There was no urgency in signing the necessary contracts with the most promising manufacturers, with protracted haggling over prices further delaying the process.

We now know that time was of critical importance and that the sooner procedures could be tested and perfected, the sooner a high yield of vaccine doses could be expected. The lack of urgency was also reflected in the attempt to bring a number of exogenous considerations into the process. For many months the European Union seemed more interested in scoring political points on solidarity, market power and negotiating clout than in focusing laser-like on the task at hand: getting as many vaccines as fast as possible into the arms of its citizens. It was easy to see all these problems coming. They were like bad omens and they kept piling up.

(…)

During a pandemic, it makes a vital difference whether vaccines are available now or in two months’ time, both in terms of saving lives and resuscitating the economy.

This was never understood in Brussels, with the Commission insisting it had secured billions of doses but forgetting to consider when these doses would be available. Even in normal times, being able to lead in key technological areas will sooner or later be translated into more visible forms of global power.

Surprisingly, EU bureaucrats themselves would continue to perceive their actions as a huge success. They kept on showing great confidence that the terms of the EU Commission’s procurement contracts were robust in best serving the interest of the European consumers and their pocketbooks. European bureaucrats were particularly proud that they had managed to drive down prices for the Covid-19 vaccines lower than their counterparts in Washington.Footnote 394

There could have hardly been a more alienated way of reasoning at the EU policy level, since as a result of this completely unworldly stance, the vaccination campaign in EU countries would run into months-long delays, as of January 2021.Footnote 395

9.4.3.5 Lack of Awareness That, Ultimately, the European Population Would Have to Pay the Price for the EU’s Many Mistakes in Procuring the Covid-19 Vaccines

In our opinion, the EU purchasing strategy was a severe debacle. It was deeply callous of the EU to reason that savings of a few million euros could ever weigh up against the loss of lives that every delay in starting the vaccination campaign implied. Moral objections aside, it was also mind-bogglingly naive to strike a bargain which would be immediately wiped out by the massive, economic losses from the continuation of the lockdowns (cf. Sect. 2.4.3), at a time when countries such as Israel and the United States already would be able to start functioning relatively normally again.

At the beginning of 2020, the European population could start to see for themselves how badly they fared under the policy choices the EU had made. The (at the time prevailing) prospect that most of the EU population would, at best, only have access to the less effective Oxford-AstraZeneca Covid-19 vaccine (where it remained for a long time unclear whether this vaccine was still sufficiently effective from a certain age threshold, next to protecting against certain mutations/variants of the Covid-19 virusFootnote 396) caused a great concern among a large part of the EU population, with even those first summoned to receive the Oxford-AstraZeneca jab refusing to show up. Incidentally, among those who refused the Oxford-AstraZeneca Covid-19 vaccine, was a large proportion of healthcare workers themselves.Footnote 397

The EU and the national authorities of several of the EU Member States responded to this hesitancy with regard to the Oxford-AstraZeneca Covid-19 vaccine by means of a campaign of persuasion (worthy of a dictatorial regime), increasingly—and against all facts—advocating that the Oxford-AstraZeneca Covid-19 vaccine, in reality, did not exhibit any of the flaws reported previously, which, of course, has been but another factor of distrust for many.

As phrased by FranklinFootnote 398:

The European Union is now waking up to what it needlessly missed out on. Worried EU governments are now desperately reassuring their populations that the Oxford AZ vaccine is safe and effective. The French have just relaxed the restriction on the vaccine’s use among the over 65s. The Germans are likely to follow suit. Thomas Mertens, head of Germany’s expert panel on vaccine use, has promised an “update” to the current regulations. He was at pains to point out that the existing restriction were never about safety concerns and added that “somehow the whole thing went kind of badly wrong.” Yeah, “somehow”.

In Flanders (Belgium), public policy was during some time even such that people who refused the Oxford-AstraZeneca Covid-19 vaccine would not be given any other choice (i.e., a “take it or leave it”-principle),Footnote 399 with the Flemish government not even appearing to have questioned how such an approach related to some of the fundamental rights guaranteed by the ECHR, which imply a minimum protection with regard to the right to integrity of the human body, in addition to an elementary right to a full and adequate medical treatment.Footnote 400

9.4.3.6 Further Comparison with the Approach of the United Kingdom and the United States

How delusional can policymakers and bureaucrats get?

Convinced that by, supposedly, having negotiated with the Covid-19 vaccine manufacturers in a “hard”, rather than a swift and efficient manner, they had done the EU citizen (and by extension the European economy) a huge favour (notably by having obtained the lowest possible prices for the Covid-19 vaccines), European policymakers and bureaucrats then also tried to get the ((Br)exiting) United Kingdom behind the EU vaccination policy choices. The European Commission thus offered the United Kingdom the chance to join its disastrous Covid-19 vaccine procurement programme, but London—already having to deal with the harsh reality of Brexit—wisely turned down the offer. Instead, the United Kingdom simply signed its own purchasing agreements. In addition to purchasing the Oxford-AstraZeneca developed Covid-19 vaccine, the UK government also signed deals for procuring the Covid-19 vaccines developed by BioNTech-Pfizer and—shortly after the release of the preliminary trial data—from Moderna as well.Footnote 401

But where the United Kingdom would really get ahead of the EU in the Covid-19 vaccination race was in approving the actual deployment of the several Covid-19 vaccines.

By 20 November 2020, BioNTech-Pfizer had already submitted its request to obtaining an EUA to the US FDA.Footnote 402 (Cf. Sect. 9.3.1.3) Given the EU’s own apparent complete lack of interest in making the mRNA Covid-19 vaccines available within the EU as soon as possible, BioNTech-Pfizer waited until 1 December 2020 to submit a similar application to the EMA (short for the “European Medicines Agency”).Footnote 403 However, the United Kingdom wisely chose to pre-empt both the US and EU supervisory agencies, thus becoming the first Western country to give a formal green light to a Covid-19 vaccine, by dispensing some of the requirements under the formal application procedure. More in particular, the UK Medicines and Healthcare products Regulatory Agency, already on 2 December 2020, gave a temporary approval to the BioNTech-Pfizer Covid-19 vaccine, based simply on the report about the Phase III trial data with regard to this vaccine it had earlier received.Footnote 404 A few days later, a first dose of the BioNTech-Pfizer Covid-19 vaccine, outside the scope of trial testing, was administered in the United Kingdom (cf. Sect. 9.4.4). It was for many observers clear that this would have been impossible without Brexit, which according to some also indicated a differences in priorities that prevailed on the two different sides of the Channel.Footnote 405

At about the same time, the US FDA—11 days ahead of the EU EMA—also rushed to give a EUA to the BioNTech-Pfizer Covid-19 vaccine.Footnote 406 Eleven days would under normal circumstances be considered an insignificant delay in the land of drugs regulation. However, against the background of a raging global pandemic, lost days very likely equalled thousands of lost lives,Footnote 407 as well as huge economic damage.Footnote 408

Being one of the United States’ biggest pharmaceutical enterprises, Pfizer itself had not received any form of financial support under the Trump administration’s Operation Warp Speed. However its partner (and actual developer of the BioNTech-Pfizer Covid-19 vaccine), BioNTech, had itself received a loan from the EIB, besides actual financial support from the German government. One could have thus expected that BioNTech-Pfizer would first have turned to the EU for getting a regulatory approval on the use of their vaccine. However, most probably in the light of Pfizer’s own bad experiences in its contract negotiations with the EU, the New York-based enterprise Pfizer wisely chose to coordinate the clinical trials needed for getting regulatory approval in close cooperation with the US supervisory agency FDA—rather than with the EU supervisory agency EMA—as well as with Germany’s own vaccine regulator, the Paul Ehrlich Institute.Footnote 409 This at the same time helps explaining why the request for (temporary) approval of the BioNTech-Pfizer Covid-19 vaccine was first made in the United States. In the end, the US FDA granted an EUA for the BioNTech-Pfizer Covid-19 vaccine on 11 December 2020, which was just three weeks after the two enterprises had submitted their application. The EMA granted a similar temporary permission some 10 days later. (Cf. Sect. 9.3.1.3.)

Notwithstanding the fact that it took the EMA one day less than the FDA to make its decision between the date of the formal application and the ultimate decision, it was clear that, by then, the EU had not only lost the Covid-19 vaccination race with regard to the procurement of the Covid-19 vaccines, but also with regard to granting the necessary regulatory approvals, adding a further cause to the fact that the Covid-19 vaccines, by early 2021, were much less available in the EU than in the United States, besides a variety of other countries that had all been much quicker in responding to the challenges posed by the ongoing Covid-19 pandemic itself in relation to the rapid development of functional Covid-19 vaccines.Footnote 410

9.4.3.7 Late Start of the Vaccination Campaign in the EU and Problems with Supply Shortages

In early 2021, political leaders across the European continent began to protest about the delays of the EU vaccination campaigns.Footnote 411 Worse still, it appeared that EU citizens were mostly denied access to the most effective Covid-19 mRNA vaccines that could slow the epidemic on the continent and save their lives.Footnote 412

Vaccinations within the EU slowly began on 26 December 2020, when three EU countries—Hungary, Germany and Slovakia—had rushed to accept the European Commission mission’s invitation to begin inoculating people as of 27 December 2020).Footnote 413 This was almost 2 weeks after the first Covid-19 vaccinations had been administered in the United States and almost three weeks after pictures of the first woman being vaccinated with the BioNTech-Pfizer Covid-19 vaccine by the UK National Health Service had been released to the world’s media.Footnote 414 (Cf., furthermore, Sect. 9.4.4.2.)

Notwithstanding the delays and clearly not in the least embarrassed about the many mistakes that had been made during the negotiations and the procurement process for acquiring the Covid-19 vaccines, European Commission’s mission chairwoman, Urusla von der Leyen, was surprisingly quick to call the coordinated deployment a “true European success story”, although many other politicians, let alone the EU citizens themselves, did not share this over-enthusiastic assessment.Footnote 415

Given the terms of the agreed upon purchase agreements, and even though the initial EU order for doses of the BioNTech-Pfizer Covid-19 vaccine had been double that of the United States, it soon got clear that the cooperating vaccine producers had planned to deliver the purchased doses of their Covid-19 vaccine at a much faster rate to the United States than to the EU itself. Pfizer thus explicitly committed to deliver 200 million doses of the BioNTech-Pfizer Covid-19 vaccine to the United States by the end of July 2021, for which Pfizer would resort to the production that it accomplished through its American factories, while the EU itself was not even guaranteed that it would receive this same number by the end of September 2021.Footnote 416 Moreover, at the beginning of 2021, supply disruptions started to occur which BioNTech and Pfizer completely passed on the EU, while deliveries to the United States largely continued as agreed upon. When on 15 January 2021 Pfizer-BioNTech thus announced that they would have to reduce supplies of the vaccine to some countries for a few weeks in order to upgrade their plants to be able to produce doses more quickly, it was mainly the EU that was affected by this measure, while the vaccination campaign in the United States itself could go ahead as planned.Footnote 417

Deliveries to the EU by Moderna were even worse, as Moderna itself had already warned around the middle of November 2020. Moderna’s Covid-19 vaccine had ultimately been approved on a temporary basis by the EU EMA on 6 January 2021, several weeks after the US FDA had granted the Moderna Covid-19 vaccine a EUA for use within the United States.Footnote 418 Most probably due to the experiences that Moderna had endured during its negotiations with the EU, Moderna from the outset announced a limited supply to the EU throughout 2021, committing only 10 million doses of its Covid-19 vaccine for delivery to the EU throughout Q1 2021.Footnote 419

When, on 22 January 2021, AstraZeneca as well announced that deliveries of its Covid-19 vaccine to the EU would not be a top priority, the European vaccination campaign was down and out before it even began, and would remain so until the end of April 2021.Footnote 420

At the same time, it appeared from preliminary customs data that millions of Covid-19 vaccines produced on EU soil, had simply been exported from the EU to Britain, Canada, Israel and China. Britain, Israel and Canada all declared that they received their doses of the BioNTech-Pfizer Covid-19 vaccine exclusively from EU countries. Britain also declared that it received doses of the Oxford-AstraZeneca Covid-19 vaccine from the EU, notwithstanding the fact that AstraZeneca had two operational production plants on British soil.Footnote 421 So, while, on the receiving end, the EU was facing huge delivery problems with regard to all three main Covid-19 vaccines—bearing in mind that the Johnson & Johnson Covid-19 vaccine was at the time not yet ready—it nevertheless allowed a massive export of Covid-19 vaccines produced within the EU itself to other territories, in this manner denying its own citizens access to the life-saving product.

The afore-mentioned drastic announcements by the three main Covid-19 vaccine-suppliers the EU had been counting on, would eventually force health ministries all over the European continent to completely rewrite their vaccination plans throughout Q1 2021 and the month of April 2021,Footnote 422 with a single EU Member State, notably Hungary, even starting to look at Russia and China for deliveries of their own Covid-19 vaccines.

9.4.3.8 Criticism on the EU’s Stinginess

While throughout the months January-April 2021, panic over Covid-19 vaccine shortages in all EU member states mounted, many started questioning the EU Commission’s policy of having pursued low prices to the detriment of fast deliveries.Footnote 423

Israel, which at the time was taking the lead in inoculating its population, made no attempt at hiding the fact that its “whatever-it-takes approach” for acquiring the Covid-19 vaccines had involved shelling out more,Footnote 424 a strategy which had proven highly effective, to the extent that Israel soon became the country most likely to reach herd immunity because of its vaccination strategy.Footnote 425

The United Kingdom and the United States had, in a similar manner, also been willing to pay more per dose of the Covid-19 vaccines than the EU. Published figures about the prices paid for the Covid-19 vaccines indicate that the EU had been willing to pay less than USD 2 per dose of the Oxford-AstraZeneca Covid-19 vaccine, while the United States had been willing to pay around USD 4. When considering these figures, one has to bear in mind that the United States did not rely on the Oxford-AstraZeneca vaccine in their own campaign (nor did it intend to), while for the EU, the Oxford-AstraZeneca Covid-19 vaccine had at the time been indicated as the central piece of the EU vaccination campaigns. The United States had, phrased differently, been willing to pay the double for something it did not consider all that important. From the aforementioned data, it also appeared that the United States had negotiated a USD 20 price tag per dose for acquiring the BioNTech-Pfizer Covid-19 vaccine, and Israel even a price tag of more than USD 40 per dose. In contrast, the price that the EU had been willing to pay for a dose of the BioNTech-Pfizer Covid-19 vaccine only amounted to USD 15, which presents a further insight in the value the EU warrants to the lives of its citizens in comparison to less stingy countries.Footnote 426

On January 23, 2021, in a column named “Our worst policy error”, Wolfgang Münchau, the then-head of the London-based “Eurointelligence” think tank and a frequent critic of Brussels initiatives, gave the following assessment of the EU’s stinginess, in which he severely criticized the EU’s wrongheaded policy choice of prioritizing price over delivery.Footnote 427 Considering this opinion being so right on the money, it is hereafter quoted completely:Footnote 428

It looks like I might have been a bit premature when I predicted that austerity would go down as the EU’s worst policy error during my lifetime. In one sense this prediction from the time of the eurozone crisis will probably turn out to be correct.

Austerity triggered economic divergence that will be hard to reverse.

But the EU vaccine’s policy must be a close contender for that title. As of January 22, the EU had vaccinated only 1.89% of its population, whereas the UK vaccinated 9.32%. Moreover, the daily rate of increase is faster in the UK. UK vaccinations not only started earlier, but the gap is also still widening.

You can’t blame logistical errors. What happened is that the EU did not secure enough vaccines. That, in turn, slowed down the pass-through. The Commission’s headline numbers are not deliveries. Already in November, the head of Moderna warned that the EU was dragging out negotiations. AstraZeneca, which is distributing the Oxford vaccine, said deliveries to the EU will take longer than previously anticipated. Pfizer, which distributes the German BioNTech vaccine, is now warning the EU of supply bottlenecks because of problems with a production site in Belgium.

What happened here is that the EU did a Brexit trade deal with the pharma industry: it tried to lock in a perceived short-term price advantage at the expense of everything else. Instead of prioritizing the speed and security of supplies at any price, the EU prioritized the price. The EU paid 24% less for the Pfizer vaccine than the US, for example. For the Oxford/AstraZeneca vaccine, the price gap is 45%. The UK almost certainly paid a lot more. It is no wonder that the manufacturers are prioritizing orders on a first-come, first-serve basis, and from countries that pay the full price. The price difference is macroeconomically irrelevant. But if vaccine shortages lead to longer lockdowns, the indirect effect of that short-sighted policy will be massive.

At one point, the cost of this policy error will also be measurable in terms of human lives. This is not possible now because we don’t know the future spread of the virus. We know that the UK mutant has arrived on the continent but has not yet unleashed its full pandemic force. In the most benign scenario, the current lockdown might prevent the worst. In the worst-case scenario, the vaccination delay would be a calamity that could costs tens of thousands of lives.

So why did EU governments shift responsibility for vaccination procurement to the EU in the first place? Angela Merkel reasoned that it would have strained EU cohesion if Germany had procured privileged supplies of the BioNTech vaccine. What she did not consider is that the EU is ill-equipped for this task. To this day, the EU’s DNA is that of a producers’ cartel. Its priority is not to secure supplies but reduce costs and achieve some balance between French and German interests. Triangulation is what Brussels does for a living. Whatever-it-takes is not part of its culture.

On a broader perspective, the vaccine disaster is the culmination of a trend that started with the Maastricht Treaty. Until then, the EU did only a few things well: the customs union, the Schengen travel zone, and to a lesser extent, the single market. The EU’s competencies have progressively widened since, but the results are mostly disappointing. In the early 2000s, the EU obsessed about the Lisbon Agenda for structural reforms, which brought few concrete benefits. Nor did the Juncker investment programme a decade later. The vaccination disaster differs in only one respect: it will be blamed for the loss of human lives.

There will undoubtedly be calls for resignations. But for me, the more important issue is the conclusions EU citizens will draw from it. For starters, the EU has just provided a hindsight argument in favor of Brexit. The UK would not have proceeded with vaccinations as quickly if it had subjected itself to the same policy. The last thing the EU ever wants to do is give people a rational, non-ideological reason for Euroscepticism.

It has just done that.

In a similar manner, albeit a bit shorter, on the same date, Guntram Wolff, director of the Bruegel think tank in Brussels, tweeted the followingFootnote 429:

The EU spends less per vaccine shot than other industrial countries. This stingy approach cost lives. It’s incomprehensible, why budget line for vaccine purchases was so limited while lockdowns cost hundreds of billions. More financial incentives needed to boost production now.

To the extent that the EU Commission sacrificed speed for stinginess and solidarity, while at the same time trying to reach an understanding with the Covid-19 vaccine providers concerning possible liabilities, it remains an open question whether it got what it wanted.Footnote 430 For a supranational institution that prides itself on consistently prioritizing both economic interests and principles, this approach demonstrated a clear lack of insight into the basic dynamics of capitalist economies: when negotiating the purchase of Covid-19 vaccines, the EU was not on a buyer’s market. Speed was of the essence, as countries from all over the world vied for priority access in the vaccine queue, while it was also clear that production and supply of the Covid-19 vaccines would not be able to meet demand.Footnote 431 Also, the heavy-handed treatment of, e.g., manufacturer Moderna—cf. the public statement of the latter of 17 November 2020, quoted before at Sect. 9.4.3.4—apparently testified to little insight from the part of the EU on how to deal with suppliers of a scarce and vital product.

There has also been strong criticism regarding the poor quality of the EU vaccines purchasing task force itself which has been considered not being up to the task. Wheeldon has in this regard pointed out that, while the EU Commission is very good at negotiating things like trade deals, it traditionally did not have any competence whatsoever in matters as vaccines and vaccine contract negotiations which had in the past always been left to the Member States themselves. For some, the EU Commission, had mistakenly aggrandized its competence, although it was clearly not up to the job, lacking both the competent people and the experience for such an undertaking. By contrast, the United Kingdom had put a successful venture capitalist specialised in biosciences, notably Mrs Kate Bingham, at the head of its Covid-19 vaccine acquisition program. Bingham’s specific professional expertise was in purchasing vaccines and drugs, as well as in drawing up purchasing agreements with pharmaceutical enterprises, while none of that was the competence of Ursula von der Leyen or anyone within the Gallina task force.Footnote 432 (Cf. Sect. 9.4.3.3)

The policy choice of deploying an unqualified task force, which then moreover prioritized price above speed, caused great delays by December 2020. Further policy choices and austerity measures doomed all other attempts at a truly equal approach to the vaccination process,Footnote 433 both in terms of the relationship between the EU member states, as between individual European citizens.

Be this as it may, on 19 January 2021, when just over 5 million Covid-19 vaccines had been administered throughout the EU, the EU Commission still deemed it fit to announce targets according to which at least 80% of EU health laborers and the elderly above the age of 80 would be served with a Covid-19 vaccine by March 2021, and 70% of the EU adult population by the end of the summer of 2021. Moreover, while at the time hardly having received deliveries of the Covid-19 vaccines for itself, the EU announced that it would start donating excess doses of the Covid-19 vaccines to poorer countries.Footnote 434

There is little room for denying that, while, during the months of January and February 2021, the variety and the available numbers of Covid-19 vaccines in the United Kingdom were not as wide and big as they were across the Atlantic Ocean, but at the same time, no European country had vaccinated more people than the United Kingdom. If the United Kingdom had then still been a member of the EU, already on 22 January 2021, it would have been the only country on track to achieve the EU Commission’s goal of vaccinating 70% of the adult population by the summer of 2021 (and, hence, for once being among the best students of the EU class).Footnote 435 What is as clear is that the EU’s prioritizing price over speed has cost not only precious time, but also precious lives.

As Maçães has phrased it:Footnote 436

I now fear that the European Union will find itself in the impossible situation of having to prolong some of the existing restrictions beyond the summer, while both Britain and the United States start to normalize. That is the cost of the vaccine delays: a very high cost in lives, prestige and further economic losses. The current crisis has the potential to spiral out of control. The imperative was to reduce the risks of that happening, no matter what the immediate financial cost.

As the EU vaccine procurements came under increasing attack from all possible sides during the second half of January 2020, EU bureaucrats, Gallina in the lead, were still particularly notable for the fervour with which they continued to defend the EU’s strategic choices. In clear denial of all contradictory facts, Gallina said that she was still convinced that the EU was better off than Israel, the United Kingdom and the United States, pointing out that the EU had managed to “reserve” many different Covid-19 vaccines and had also managed to negotiate the best prices.Footnote 437 Gallina, in addition, argued that the EU was in the “top league” of Covid-19 immunization process worldwide, while denying that the Covid-19 vaccines rollout was hobbled by delays arising from the contracts with the vaccine producing pharmaceutical enterprises.Footnote 438 Gallina, furthermore, argued that, by the end of January 2021, the EU had already vaccinated more than 12 million people and that unfavourable comparisons with more successful countries such as Israel, at the time the world leader in Covid-19 inoculation, were not at all helpful.Footnote 439

However, the EU bureaucrats remained unable to answer the real questions regarding the extreme slowness of Covid-19 vaccine deliveries to the EU, throughout Q1 2021 and deep into April 2021.

In early February 2021, EU Commission President Ursula von der Leyen herself acknowledged that, when negotiating and signing the Covid-19 procurement agreements, the EU had been too optimistic about the rapid production and delivery of the Covid-19 vaccines, but also continued to emphasize that the joint purchase by Brussels had been the right strategy.Footnote 440 von der Leyen, furthermore, came up with the remarkable argument that “the battle against the virus is a marathon, not a sprint”.Footnote 441

This desperate defence of the EU’s strategic choices by both Von der Leyden and the chair of the vaccine procurement task force, however, had no impact whatsoever on the failure of the deliveries—and, hence, of the vaccine administrations—themselves.

As Franklin has assessed this attitude of the EU leadershipFootnote 442:

As an institution, the EU displays a pattern of behavior that in an individual would be diagnosed as petty narcissism. We all know the type of person: the character flaw isn’t obvious at first, but they soon give themselves away. In place of the usual give-and-take of a healthy human relationship, they think they’re doing you a favor just by allowing you to interact with them. Furthermore, you will be expected to pay for the privilege. This means abiding by their rules; having to guess what they want without being told; prioritizing your relationship with them above any other attachment. Resist their nonsense and you’ll be accused of being the unreasonable one.

9.4.3.9 In Between-Conclusions Regarding the EU’s Failed Covid-19 Vaccines Procurement Policy

In light of the foregoing, the EU policy of dealing with Covid-19 has failed in many ways and on many occasions.

Especially since the enactment of the 1992 Maastricht Treaty, the EU has committed itself heavily to implementing neoliberal doctrine. Already before the creation of the EMU, the emphasis on the interests of the trade, financial and industrial sectors have been high on the European Communities’ agenda, at the expense of other possible interests within the socio-economic sphere, such as care for the environmentFootnote 443 and public health (of which, incidentally, hardly any trace can be found in the European treaties), and certainly not in case these other socio-economic interests would collide with economic interests themselves.

As has been demonstrated throughout the previous Chapters of this book, the European neoliberal political agenda has during the past three to four decades increasingly, and on a wide variety of policy topics, determined the policy of the EU member states as well. The combined effect of submitting EU policy and the policy of the EU Member States to the doctrines of economic neoliberalism, has in times of Covid-19 proven to be especially detrimental.

Let us briefly summarize some of the findings of the previous Chapters about what this has implied for the European policy responses to Covid-19.

First, in full accordance with neoliberal logic, most EU Member States have during the past decades increasingly pursued an austerity policy in the field of healthcare. (Cf. Chap. 5) As a result, when Covid-19 hit Europe as of January 2021, little was left of any preventive health policy in most EU Member States, nor was there much to be seen thereof at the EU level itself, to the extent that the EU had no significant competences in this area. The combination of these two elements—a far-reaching austerity policy at the level of the EU Member States and the absence of significant competence, or even interest, regarding public health matters at the EU level itself—implied that, when Covid-19 reached the European territory in January 2020, both the EU itself, as its Member States, could only stand by and watch. There were, e.g., no EU institutions mandated to cope with a pandemic. Nor were there any stocks of protective or other medical equipment needed to combat such a health crisis available anywhere. This dearth of equipment ranged from ordinary facemasks for general use, to more advanced medical protection gear or equipment needed for the treatment of Covid-19 patients (such as, e.g., respirators). The leaders of certain European Member States would even bluntly lie to the public, explaining that face masks offered no protection against the Covid-19 virus anyhow, even while Asian countries, far more experienced in such health crises, generally relied on facemask wearing to combat coronavirus outbreaks. In addition, in many European countries, after decades of neoliberal austerity policy decisions in the field of healthcare, the capacity of the hospital sector turned out to be unable to cope with the large wave of Covid-19 contamination cases. In many EU Member States, this led to the most dramatic situations, including the systematic refusal of admitting members of the elderly population (in particular long-term nursing home residents) to hospitals, implying that they were left to die in their retirement home, or even at home, under the most appalling conditions. (Cf. Chap. 6) There was, furthermore, a complete lack of knowledge on how to respond to the Covid-19 pandemic, which resulted in completely wrong advice to the general public—such as statements that the Covid-19 outbreak was no worse than a seasonal flu or that face masks did not offer any protection whatsoever -, as well as in terms of failing to work out sound policy measures for several months after the outbreak of the pandemic. In the meantime, throughout the months of February and early-March 2021, the Covid-19 pandemic spread wildly throughout Europe, resulting in astronomical death rates, while in various Asian countries—but also in some countries of Oceania –, thanks to much more efficient government response, the Covid-19 pandemic was in many cases contained far more quickly. (Cf. Sect. 2.4.2.4) It is in this regard most significant that, even at a time after the WHO had already issued clear warnings about the seriousness of the situation, and after several cases of Covid-19 had already been identified on the European continent (by the end of January 2020), the EU would still continue for the next one and a half month to give absolute priority to all kinds of economic matters, in addition to the migrant problem and the EU relationship with Turkey, but did not deign itself to any significant action to combat Covid-19. As a result of this completely lax attitude on the part of the EU (in addition to numerous EU Member States), the Covid-19 virus had all this time free rein to spread across the entire European continent (besides Great Britain). The consequences have been correspondingly dire: already by the end of March 2020, the EU had the dubious status of being the Covid-19 pandemic’s centre of gravity.

Those who think that, after having learned these painful lessons, the EU would have been inclined to correct its past mistakes by embracing the quickly developed Covid-19 vaccines (cf. Sect. 9.3.1) and by aiming at acquiring them as quickly and efficiently as possible, would find himself again mistaken.Footnote 444

Faced with the negotiators of the Covid-19 vaccine producers who mainly envision a profit-making goal (cf. Sect. 9.2), EU officials tried to drive a hard bargain, as neoliberal doctrine equally teaches that every cent spent on the common good, e.g., on public health, is a waste of resources. Precisely this attitude is the reason why the EU negotiators would later proudly declare that they had managed to negotiate the lowest possible prices for the Covid-19 vaccines. (Cf. Sects. 9.4.3.3 and 9.4.3.4)

The combination of these elements has ensured that the EU, next to the EU Member States themselves (which had submitted to an unworldly principle of European solidarity on the subject of vaccine negotiations, apparently under the guise that the bulk purchaser would be able to negotiate a lower price) were among the last in the Western world to secure their contracts with the Covid-19 vaccine manufacturers, albeit at the lowest price. At least one of the vaccine producers, namely Moderna, explicitly warned that the actual vaccine deliveries would be based on a “first come, first served” logic (cf. Sect. 9.4.3.4), which should have led the EU to suspect that the actual deliveries would turn out to be problematic.Footnote 445

As Andreas Kluth wrote:

(…) the Eurocrats have unwittingly staged something like a parody of Brussels.

The EU was slow to strike deals and timid in the haggling. Its regulators took too long to approve vaccines that came on the market, including home-grown ones. Brussels then reacted badly to production shortfalls.

And thus, it happened.

When three of the most promising Covid-19 vaccines became available for distribution by the end of 2020, the EU (and with it, the EU Member States) could but observe how various other countries were getting off to a flying start with vaccinating their population, while the EU itself was barely receiving any deliveries. This also gave immediately rise to the suspicion that this situation would only come to an end after the entire population of the “first-in-line countries” would be vaccinated, with as result that, as the calendar year 2021 progressed, all hope that the entire European population would still be vaccinated in that same year, gradually diminished.

A far-reaching neoliberal policy has disrupted the population of the European continent on two levels: (1) On the one hand, by having to live under a regime that was completely unprepared for the arrival of a pandemic and, (2) on the other hand, by reaching the painful conclusion that even a health crisis of the size of a global pandemic, has, regretfully, not been able to motivate EU leadership to abandon the subordination of public healthcare to neoliberal economic principles.

Even Paul Krugman saw himself, on 18 March 2021, compelled to comment on the EU vaccination failure, in an opinion piece that appeared in The New York Times, in which Krugman wrote the following:Footnote 446

(…) at this crucial moment in the Covid-19 saga, when new vaccines finally offer a realistic prospect of returning to normal life, policy in the European Union has been marked by one bungle after another. Jabs in arms got off to a slow start: Adjusted for population, Britain and the U.S. have administered around three times as many doses as France or Germany. And the E.U. countries are still lagging, administering vaccines less than half as rapidly as we are.

Europe’s vaccination debacle will almost surely end up causing thousands of unnecessary deaths. And the thing is, the continent’s policy bungles don’t look like isolated instances, a few bad decisions made by a few bad leaders. Instead, the failures seem to reflect fundamental flaws in the continent’s institutions and attitudes — including the same bureaucratic and intellectual rigidity that made the euro crisis a decade ago far worse than it should have been.

The details of the European failure are complex. But the common thread seems to be that European officials were not just risk averse, but averse to the wrong risks. They seemed deeply worried about the possibility that they might end up paying drug companies too much, or discover that they had laid out money for vaccines that either proved ineffective or turned out to have dangerous side effects.

So they minimized these risks by delaying the procurement process, haggling over prices and refusing to grant liability waivers. They seemed far less worried about the risk that many Europeans might get sick or die because the vaccine rollout was too slow.

9.4.3.10 Aftermath

9.4.3.10.1 March 2021: Searching for a Scapegoat

According to information provided by the European Centre for Disease Prevention and Control, as of December 2020, all EU/EEA countries started to develop strategies or plans for the roll-out of the available Covid-19 vaccines. The majority of said countries thereby aimed at launching their national Covid-19 vaccination campaigns at the end of December 2020, shortly after the delivery of the first batches of the Comirnaty vaccine, i.e., the name for the Covid-19 vaccine developed by BioNTech-Pfizer. By February 2021, all EU/EEA countries also started administering the Moderna Covid-19 vaccine and the Oxford-AstraZeneca Covid-19 vaccine.Footnote 447

Vaccinations in the EU/EEA countries were to be rolled out in phases, with all EU/EEA countries starting with the inoculation of certain priority groups that had been selected based on their higher risk for developing severe Covid-19 disease. This mainly concerned the elderly and the residents of long-term nursing facilities. A second priority group were the healthcare laborers and certain other frontline workers.Footnote 448

At that time, ECDC and the WHO Regional Office for Europe jointly established a tracking system for collecting information on the roll-out of the Covid-19 vaccines in Europe, including data on the precise number of doses of the Covid-19 vaccines shipped to EU/EEA countries by the vaccine producing enterprises, as well as data on the exact number of Covid-19 vaccine doses administered to people divided by age group and other ranking criteria. The objective of this tracking system was to gather data on (1) the effectiveness of the vaccination campaigns at a national level in terms of delivering doses of the Covid-19 vaccines to the targeted priority groups; (2) the capacity of countries to deliver all available doses of the Covid-19 vaccines to the members of their population; and (3) the identification of any gaps in the Covid-19 vaccine deployment and vaccination campaign progress. As of 15 January 2021, these data were assembled through the European surveillance system (abbreviated as “TESSy”) and could be consulted on the ECDC website under the form of Covid-19 vaccine tracking tables.Footnote 449

Already at the beginning of February 2021, it started to become clear that the EU would be dealing with a cost of tens of billions of euros because of the delayed and chaotic roll-out of its Covid-19 vaccination campaigns, compared to countries where the vaccination campaigns were making rapid progress, such as the United States and the United Kingdom. It was then estimated by Bloomberg Economics that the ongoing need for lockdowns throughout the EU because of delayed inoculations, implied that the EU bloc’s economy was only functioning at about 95 per cent of its pre-Covid-19 pandemic level, equating to about 12 billion euros (USD 19 billion) per week of lost economic output.Footnote 450

At the time, the EU was already running weeks behind some of its peer countries in terms of Covid-19 inoculations, while at the same time proceeding at a much slower pace with scheduling new vaccination appointments. Unless the EU would, somehow by miracle, start to gain ground, it was expected to be compelled to maintain lockdowns, or similar Covid-19 containment measures, while the other major economies, notably those of the United States and the United Kingdom, would be able to fully return to work. Bloomberg estimated that a further vaccination delay of 1 to 2 months would imply economic losses of 50–100 billion-euro (USD 80 billion—USD 160 billion), while it was already then feared that the delays would be much longer than only 1–2 months.Footnote 451 These early calculations on the economic loss of the EU vaccination procurement failure highlighted the massive stakes for the EU Commission, which at the time, moreover, became entangled in a public discussion with vaccine producer AstraZeneca over supply delays and over threats that the EU would start imposing export restrictions for Covid-19 vaccines.Footnote 452 At the time, according to the Bloomberg Vaccine Tracker, the EU had been serving a mere 2.9 doses of the Covid-19 vaccines per 100 people, far under the 14.7 of the United Kingdom and the 10 of the United States.Footnote 453

As if all of this was not disastrous enough, as of February 2021, many further problems occurred with the Oxford-AstraZeneca Covid-19 vaccine. For the EU, the Oxford-AstraZeneca Covid-19 vaccine had from the beginning been an important component of its vaccination plans, despite the obvious disadvantages of the vaccine that were already clear when the EU went ahead with its procurements, most notably the fact that the efficacy rates of the Oxford-AstraZeneca Covid-19 vaccine were far under these of its mRNA counterparts, notably the Pfizer-BioNTech and Moderna Covid-19 vaccines, implying that being inoculated with the Oxford-AstraZeneca Covid-19 vaccine would for many people all over the world never be their first choice, further exacerbated by the fact that it was becoming clear that several of the clinical trials of the Oxford-AstraZeneca Covid-19 vaccine had been conducted in such a manner as to elicit further criticism. It later also appeared that the Oxford-AstraZeneca Covid-19 vaccine was less effective than the other Covid-19 vaccines for protecting against new variants of the Covid-19 virus. But the EU—which had convinced its Member States that a joint procurement of the Covid-19 vaccines was preferable to a scenario in which individual Member States would have competed one another for access to the scarce Covid-19 vaccine supplies—had made a huge bet on acquiring doses of the Oxford-AstraZeneca Covid-19 vaccine, most probably because it was the cheapest vaccine available on the market, and for the EU bureaucrats who were in charge of purchasing the Covid-19 vaccines, nothing else had mattered more than paying the lowest possible prices. (Cf. Sects. 9.4.3.3 and 9.4.3.4.)

Obviously, the EU’s big bet on the Oxford-AstraZeneca Covid-19 vaccine came before AstraZeneca had notified the European Commission that it would be unable to meet its initially promised deliveries of 270 million doses during the first half of 2021, and that it would only be capable of delivering around 100 million doses during said time period. Then, to make things even worse, in the second half of March 2021, news started to make the front pages about blood clots being found in several people to whom the Oxford-AstraZeneca Covid-19 vaccine had been administered. Vaccine politics are of an extremely sensitive nature. Already, all over the world, the Covid-19 vaccines had themselves been met with a lot of criticism and even suspicion, which was in particular the case for the Oxford-AstraZeneca Covid-19 vaccine, due to the fact that the vaccine was considered less effective than the mRNA Covid-19 vaccines. The United States had even still not granted an EUA to the Oxford-AstraZeneca Covid-19 vaccine. This explains why some countries reacted to the fact that side effects were reported about the Oxford-AstraZeneca Covid-19 vaccine by immediately putting its use to a halt, “out of an abundance of caution” and in order to prevent further undermining public confidence in the vaccine. Ironically, a wide variety of other EU countries then followed suit, which in turn hurt the public confidence in the Oxford-AstraZeneca Covid-19 vaccine even more. A notable exception was Belgium, usually not reluctant for brutalizing its population, that simply went ahead with administering the vaccine as if nothing was going on, even making an offer to purchase the stocks other countries would not be using any more.Footnote 454

These problems with the Oxford-AstraZeneca Covid-19 vaccine resulted in a complete crisis of confidence, which endangered the already troublesome EU vaccination campaign even more. Scepticism about the Oxford-AstraZeneca Covid-19 vaccine has since then persisted no matter what scientists said and was, moreover, bound to deepen even more. From a survey undertaken by “YouGov” around that time—by Matthew Smit announced under the headline: “Europeans now see AstraZeneca vaccine as unsafe, following blood clots scare“Footnote 455—, it more precisely appeared that less than half of the population of Spain, Italy, France and Germany deemed the Oxford-AstraZeneca Covid-19 vaccine safe. Ironically, as the EU mounted pressure to get a fair share of deliveries the of Oxford-AstraZeneca Covid-19 vaccine, just as fewer and fewer of EU citizens actually still wanted it.Footnote 456

With each additional headline about the Oxford-AstraZeneca Covid-19 vaccine, the EU’s reputation was dinged again. The EU has long been chastised as an undemocratic and bureaucratic behemoth, but as it kept struggling with acquiring sufficient vaccines, the EU was accused of gross incompetence as well. At the same time, the majority of EU citizens still did not get access to any of the vaccines, regardless their reputation of being good (namely the Pfizer-BioNTech and Moderna Covid-19 vaccines), or second-rate and even dangerous (notably the Oxford-AstraZeneca Covid-19 vaccine).Footnote 457

For all their struggles with Covid-19 vaccine rollouts at home, the EU had on the other hand been good at allowing Covid-19 vaccines produced on European soil to be exported, by mid-March 2021 having sent more than 40 million vaccines abroad.Footnote 458

End-March 2021, as the EU started looking for a way out of the mess it had created, officials thought of a new strategy to help them speed up the vaccination process: controlling vaccine exports to countries like the United Kingdom and the United States. In order to justify this approach, Von der Leyen started referring to the principles of “reciprocity” and “proportionality” in exports. Von der Leyden also declared that the EU was willing to use whatever instrument needed to ensure compliance with these principles. The EU had by then exported an estimated 34 million doses of Covid-19 vaccines,Footnote 459 including about 10 million to the United Kingdom.Footnote 460

Notwithstanding the complete disaster of the EU vaccination campaign during Q1 2021, it would take EU officials until the end of March 2021 before starting to admit mistakes had been made regarding the Covid-19 vaccination procurements. This, moreover, only happened after six EU Member States, mid-March 2021, made a public complaint about the vaccine-distribution which they considered unfair. In a joint letter to the EU Commission and the EU Council, the leaders of Austria, the Czech Republic, Bulgaria, Slovenia, Latvia, and later Croatia, had more precisely urged for opening a debate on the issue of the distribution of the available Covid-19 vaccines within the EU. On 13 March 2021, the EU Commission responded that the available doses of the Covid-19 vaccines had been divided among the EU Member States in relation to the population numbers of each EU Member State and by further taking into account epidemiological data, adding that it was up to Member State governments to establish how to distribute them further among their population.Footnote 461

Shortly after, in an article that appeared in the German newspaper “Der Tagesspiegel”, EU Commission Vice-President Timmermans was quoted admitting that mistakes had been made on the Covid-19 vaccine-orders.Footnote 462

By 23 March 2021, the United Kingdom had been administering about 46 Covid-19 vaccine doses per 100 people, and the United States 38. Meanwhile, the EU had only been serving 14 Covid-19 vaccine doses per 100 people, at a moment when, for the umpteenth time, more lockdowns all over the EU Member States were either on the horizon or already effectively being put in place.Footnote 463 (Cf. Sect. 2.4.3) The EU Commission president, Ursula von der Leyen, at the time, still kept declaring that 70% of all EU adults would be fully vaccinated for Covid-19 by the end of the summer of 2021, although at the preceding pace, it became increasingly feared that it would be well into 2022 when the EU would reach that target.Footnote 464

By the end of March 2021, EU leaders themselves started venting their own frustration over the sluggish deliveries of Covid-19 vaccines and manufacturing delays, while anxiety was rising among the EU population over the rapid spread of new Covid-19 variants. (Cf. Sect. 1.1.2.)

The contrast between the grim picture within the EU and the inoculations in its renegade member country, “Brexit Britain”, obviously did not improve the mood in Brussels. The leadership continued to deny its own culpability, while searching for a scapegoat, most notably AstraZeneca itself that continued to face production problems in its plant in Belgium, and therefore failed to deliver to the EU in accordance with what had been agreed upon. The EU more in particular blamed AstraZeneca that it favoured the United Kingdom, all the while ignoring the terms of its own purchasing agreement with the company, and the extremely slow pace at which it had reached this agreement.Footnote 465 None of these doubts, however, prevented the EU Commission from threatening to trample over the property rights of various Covid-19 vaccine manufacturers located within the EU,Footnote 466 although as often with regard to the United Kingdom, the EU’s bark would continue to prove to be worse than its bite.

9.4.3.10.2 Situation on 1 April 2021: Hardly an April Fools-Joke

From statistics released by the ECDC on 31 March 2021, it appeared that no EU country had achieved the twin goals that the EU had set out for the end of March 2021, namely that (1) 80% of healthcare laborers and (2) 80% of those aged 80 or older would by then be vaccinated. Only five countries in the EU and the EEA considered together had administered at least a first Covid-19 vaccine dose to at least 80% of those aged 80 and over. Iceland appeared to have been most successful, with a vaccination rate of 98% in vaccinating healthcare workers. Iceland also had fully vaccinated 88.5% of its elderly people. Ireland and Malta had administered the first dose to 90% of its elderly, while Sweden and Finland had vaccinated more than 85% of the elderly. Three other countries—namely Denmark, Norway and Portugal—were just under the 80% threshold. Meanwhile, half of the EU/EEA countries had not even vaccinated 60% of its elderly population. One of these was Bulgaria, with a mere 5.1% of those over 80 years old vaccinated. No data were available for several other countries, including Germany and the Netherlands.Footnote 467

Statistics regarding the Covid-19 vaccination uptake among healthcare laborers painted a similar worrisome picture. Only four countries had achieved the goal set by the EU, with Estonia and Hungary reporting having vaccinated 100% of healthcare workers with the first dose of a Covid-19 vaccine, while Romania and Spain were both over 90%. Hungary, moreover, reported a 99.6% uptake of full vaccination among healthcare workers, while Romania was just under 80%.Footnote 468

By 4 April 2021, Hungary—that had shortly before suffered the most Covid-19 deaths per capita in the EU and had one of the world’s highest Covid-19 fatality rates—was near the top of the charts for vaccinations out of the 27 EU member states, with more than 20% of its people having received at least one jab. This compared with an average of 12.5% across the EU. That was because Hungary had not waited for EMA jab approvals and had imported two Chinese and one Russian Covid-19 vaccine in order to supplement its supply shortages.Footnote 469

By 1 April 2021, just 11% of the EU bloc’s population had received at least one dose of a Covid-19 vaccine, compared to nearly 30% in the United States and more than 45% in the United Kingdom.Footnote 470 This in light of the fact that, besides the 80% goal for the abovementioned two target groups, the EU Commission had in January 2020 also set another target, namely that EU Member States were to vaccinate a minimum of 70% of all adults by the summer of 2021.Footnote 471

The ECDC statistics also revealed that 86,000,000 Covid-19 vaccine doses had been distributed to EU/EEA countries by 31 March 2021, of which 71,200,000 had been administered.Footnote 472

According to the ECDC, there were several reasons behind the missed deadlines. Among these, most countries reported as the main reason challenges related to the supply and delivery of the Covid-19 vaccines. Six countries reported staffing shortages, and another six countries reported communication challenges due to misinformation and disinformation around the Covid-19 vaccines, which had affected Covid-19 vaccine acceptance among the population. Among the latter countries were Croatia, Cyprus, Czech Republic, Germany, Romania and Sweden.Footnote 473

On 1 April 2021, when most EU Member States started to experience their “third wave” of the Covid-19 pandemic, with variants of the Covid-19 virus being present in all 27 EU member states (cf., furthermore, Sect. 2.4.3.1), Bloomberg made its own assessment of the EU vaccination campaign. According to Bloomberg, EU’s vaccine rollout remained “sluggish” because of the following reasonsFootnote 474:

  1. (1)

    Unlike the United Kingdom and the United States, the EU’s procurement efforts had not bothered to prioritize domestic deliveries first.

  2. (2)

    At the end of March 2021, some 77 million Covid-19 vaccination doses had been exported from the EU to 33 non-EU countries, in addition to millions of doses of the Covid-19 vaccines to lower income countries through the COVAX facility. While since January 2020, the EU had issued legal measures in accordance with which enterprises needed export permissions, by that time, only one delivery to a foreign country had effectively been halted.

  3. (3)

    The EU’s vaccination campaign was mainly suffering from significant delays of deliveries of the Oxford-AstraZeneca Covid-19 vaccine. By the end of March 2021, AstraZeneca had only delivered about 18 million doses of the Oxford-AstraZeneca Covid-19 vaccine since January 2021, while it had committed to providing at least 30 million doses before the end of March 2021, still well below the 120 million doses it had originally promised.

  4. (4)

    The vaccination campaigns of each EU member country was characterized by several differences. By the end of March 2021, some countries—like Ireland, Malta and Sweden—had vaccinated more than 85% of their elderly population over 80, while several other countries, such as France and Italy, only about half of the same population group.

  5. (5)

    A multitude of EU Member States had decided to temporarily use the Oxford-AstraZeneca vaccine only in some age groups; others had started to purchase vaccines from Russia, China or Israel, and some Member States were embroiled in a discussion over how the Covid-19 vaccine deliveries had to be divided across the EU bloc.

Internal fights over access to vaccines started highlighting just how difficult it was for a bloc of 27 countries to remain united under pressure.Footnote 475

On 1 April 2021, Bloomberg, in addition, announced that it had had access to an internal EU document in which EU authorities themselves had made their own assessment of the Covid-19 vaccination debacle. From this document, it appeared that five countries that had earlier before turned away more expensive BioNtech-Pfizer Covid-19 vaccine doses in favour of the cheaper vaccine version from Oxford-AstraZeneca were under the impression of having paid a high price for their mistake. Because of this, Bulgaria, Croatia, Estonia, Latvia and Slovakia, which all had declined part of their expensive BioNtech-Pfizer Covid-19 vaccine allotments in order to wait for deliveries of AstraZeneca doses, were among the slowest in the EU bloc to be able to administer Covid-19 vaccines. While Pfizer had met its commitments, AstraZeneca had delivered just 30 million of its originally committed 120 million doses throughout Q1 2021. As a result, Bulgaria and Croatia were expected to only vaccinate 45% of their populations by the middle of 2021, according to the document, the lowest in the EU after the Czech Republic. Estonia was expected to vaccinate 50%, Latvia 53% and Slovakia 46%. This in comparison to e.g., 61% in Germany, 80% in Denmark and 93% in Malta.Footnote 476

The EU Commission declared, on 31 March 2021, that more than 100 million doses of the Covid-19 vaccines had been delivered to its Member States in Q1 2021, matching its lowered target. The EU expected the pace to pick up in Q2 2021, when it was forecast to receive 360 million doses of Covid-19 vaccines.Footnote 477

Still according to information provided by Bloomberg, based upon its reading of the abovementioned EU internal document, on 31 March 2021, the EU had administered 15.5 doses per 100 people (an assessment slightly above the 11% that appeared from the above-quoted ECDC figures of the same date). This was in any case less than a third of what the United Kingdom had managed, while the United States had administered 45 doses per 100 people. The internal document concluded that the governments of the EU Member States had failed to hit the targets set by the EU Commission to vaccinate 80% of healthcare workers and people aged 80 and above by the end of March 2021, and that they would also most likely fail in achieving the 70% vaccination threshold of all adult population by the summer of 2021.Footnote 478

Be this as it may, by 2 April 2021, it had become abundantly clear that the EU had already fallen short of its (moderate) target of having at least 80% of elderly people (aged 80 years and older) and 80% of healthcare professionals vaccinated against Covid-19 before the end of March 2021.Footnote 479 Figure 9.5 presents a schematic representation of the share of people who received at least one dose of a Covid-19 vaccine on 31 March 2021 in some countries.

Fig. 9.5
figure 5

Share of people who received at least one dose of Covid-19 vaccine, 31 March 2021 [Our World in Data (2021). Statistics as of 8 May 2021]

9.4.3.10.3 Further Covid-19 Vaccine Problems and the Search for Solutions

Whereas the EU at the beginning of 2021 was still desperate for doses of the Oxford-AstraZeneca Covid-19 vaccine, by April 2021, it started pivoting to the BioNTech-Pfizer Covid-19 vaccine instead, finally indicating that it would not seek further doses from AstraZeneca beyond those already purchased. Instead, the bloc started negotiating a new contract with Pfizer-BioNTech for 1.8 billion additional doses of their Covide-19 vaccine over the next 2 years.Footnote 480

The pivot away from AstraZeneca, which had initially been the main pillar of the EU inoculation program (cf. Sects. 9.4.3.3 and 9.4.3.4), came after months of discord over delayed shipments and worries over rare potential side effects of the Oxford-AstraZeneca Covid-19 vaccine shots. The European vaccine campaign got, moreover, also confronted with Johnson & Johnson’s own delays in its rollout in Europe because of similar concerns and after regulators had paused the use of its vaccine in the United States.Footnote 481

By April 2021, with most EU citizens still having no clue when they would finally get vaccinated and with what vaccine, the EU was facing growing criticism for its extreme slow procurement of Covid-19 vaccine doses. The EU had fallen even further behind the United States and the United Kingdom, as it suffered blow after blow in its inoculation campaign, first with major supply disruptions from AstraZeneca in late January 2021, and then with the emergence of the potential rare blood clotting disorder in both the Oxford-AstraZeneca and Johnson & Johnson Covid-19 vaccines, which battered the general public’s confidence in the Covid-19 vaccines even more, leading to numerous appointment cancellations all over Europe.Footnote 482

All this finally made the EU finally turn to Pfizer during the second half of April 2021, raising the question if the EU should not have done this from the start instead of having bet on the cheaper and less effective Oxford-AstraZeneca Covid-19 vaccine (cf. Sect. 9.4.3.4). The new agreement between the EU and Pfizer-BioNTech was even to include potential booster shots to increase the immunity of people who had already been inoculated, as well as possible new shots or boosters targeting emerging variants of the Covid-19 vaccine that might prove resilient against existing vaccines.Footnote 483

On 25 April 2021, Ursula von der Leyen claimed to The New York Times that AstraZeneca had squandered the EU bloc’s trust. By Monday 26 April 2021, the EU Commission, backed by all 27 EU Member States, announced that it had decided to take AstraZeneca to court.Footnote 484

At the time, AstraZeneca had only succeeded in delivering about a quarter of the 120 million doses planned for Q1 2021.Footnote 485 Officials at the EU’s executive branch had become particularly angry at AstraZeneca’s continued reluctance in delivering vaccine doses to the EU that were produced in Oxford and Staffordshire, however, this production was supposedly prioritized for delivery to UK residents on a contractual basis. When announcing its decision to take AstraZeneca to court, a spokesman for the European Commission declared that the complaint had been filed because certain terms of the purchasing agreement between AstraZeneca and the EU had not been respected, and the enterprise had not been willing to propose a reliable, alternative strategy to ensure timely deliveries to the EU. The complaint was officially filed with the Belgian courts on Friday 22 April 2021. A first hearing before the Enterprise Court (“Ondernemingsrechtbank”) located in Brussels was scheduled for Wednesday 27 April 2021.Footnote 486

9.4.3.11 Some Final Data from April-May 2021

An interim assessment of the mid-April 2021 EU Covid-19 vaccination debacle showed that, in most EU countries, vaccine rollout had remained extremely slow during the early months of 2021. E.g., in Belgium, after facing some of the worst mortality statistics in the world, the government had focused on vaccinating the most vulnerable: by 3 May 2021, 86.8% of the elderly over 80 had been fully vaccinated, and 84.18% of the people aged between 65 and 84.Footnote 487 But at the beginning of May 2021, Belgium was only just starting to administer Covid-19 vaccines to the younger parts of its population as well. The good news was that Belgium had managed to reduce the time between the delivery of the Covid-19 vaccine doses and their actual administration, from on average 18 days in March 2021, to about four days in the last week of April 2021.Footnote 488

A similar trend could be observed in many other EU countries. Apart from the latecomers Bulgaria, Latvia, Croatia and Romania, just over 20% of the population in each of the other EU Member States had received a dose of a Covid-19 vaccine by 3 May 2021, with Malta leading the way at 52.43%.Footnote 489

For the 23 EU Member States that managed to report their Covid-19 vaccine administration data to the European Centre for Disease Prevention and Control, the median uptake rate for the people over-80 was 73.1% as of 3 May 2021. Some countries were, similar to Belgium, starting to make progress with vaccinating their general population as well. E.g., Germany was celebrating the milestone of one million doses administered in a single day on Thursday 20 April 2021, and France had broken its own record by administering 545,000 doses of a Covid-19 vaccine on Thursday, 29 April 2021 and 549,000 on Friday 30 April 2021.Footnote 490

Importantly, from internal estimates of the European Commission that were shared with the newspaper the Guardian, it appeared that shortage of supply, which had been the main and continuing problem during the early months of 2021, no longer was the main barrier by the end of April 2021.Footnote 491 While only 14 million Covid-19 vaccine doses had been delivered to EU Member States in January 2021, this increased to 28 million in February 2021, and 60 million in March 2021, after which EU officials claimed that an additional 105 million doses of Covid-19 vaccines had been delivered throughout April 2021, while the European Commission was expecting further deliveries of 125 million Covid-19 vaccine doses in May 2021, and 200 million in June 2021. Provided that these prospects were more or less accurate, this was expected to put the EU back on track to reach an annual capacity of 4 billion Covid-19 vaccine doses for 2021.Footnote 492 According to The Guardian, this was a huge departure from the rut the EU was in a few months earlier, when the two moments on which AstraZeneca had cut its planned deliveries to the EU, had led to a huge panic in Brussels and the rest of the EU.Footnote 493 It appeared that the turning point had come when, after several meetingsFootnote 494 with officials from BioNTech-Pfizer, Moderna, AstraZeneca, Johnson & Johnson, Curevac and Sanofi, on 14 April 2021, European Commission President Von der Leyen was able to announce that a delivery of 50 million additional BioNTech-Pfizer Covid-19 vaccine doses that had initially been scheduled for Q4 2021 would be brought forward to Q2 2021.Footnote 495

Table 9.4 presents an overview of the number of Covid-19 vaccines administered on 16 April 2021 in some countries.

Table 9.4 Covid-19 vaccines administered on 16 April 2021a

After all of this, by 6 May 2021, Ursula von der Leyen, still kept claiming that the EU vaccine strategy had been a “success”, although (only) a quarter of EU citizens had received a first jab of a Covid-19 vaccine.Footnote 496

9.4.4 The UK Vaccination Campaign

9.4.4.1 The Successful Procurement Approach of “Kate The Great”

The differences in approach, but also in success rate, regarding both the purchases of the Covid-19 vaccines and the actual vaccination campaigns themselves, could not have been bigger than those between the EU and the United Kingdom. The United Kingdom had, moreover, shortly before the outbreak of the Covid-19 pandemic, left the EU, which in the eyes of some confirmed that Brexit had been the right political choice.

As described before (cf. Sect. 9.4.3), the EU’s way for purchasing Covid-19 vaccines had been purely bureaucratic, with: (1) a seasoned EU official at the head of the negotiating and purchasing team, (2) an actual purchasing approach based on the most stringent EU procedures imaginable, and (3) a strategy of focusing on the cheapest prices, instead of on fast orders and deliveries.

We have already discussed in the previous Sect. 9.4.3 to which debacle this led during Q1 2021 and the biggest part of April 2021.

On the other hand, there was the completely opposite approach of the United Kingdom, with: (1) placed at the head of the Covid-19 vaccines purchasing team, a highly specialized and seasoned businesswoman (2) took a purchasing approach based upon broad investments in the vaccine candidates from various producers, coupled with quick purchasing decisions once a Covid-19 vaccine candidate seemed to be ready for use, and (3) had as overall aim liberating the United Kingdom as quickly as possible from the Covid-19 crisis into which the UK government had plunged the country throughout the year 2020.

The first step on the road to the United Kingdom’s highly successful vaccination campaign was taken when, in May 2020, UK Prime Minister Boris Johnson had taken the bold step of appointing Kate Bingham to chair the new UK Covid-19 Vaccine Taskforce, a crucial new body that was to oversee the investment and procurement of Covid-19 inoculations. According to the British press, it is not entirely clear how Johnson appointed Bingham, as no formal procedure seems to have been followed, but the mission given to Bingham was clear: to invest billions of taxpayers’ dollars in Covid-19 vaccine candidates that could offer the United Kingdom a way out of its continued lockdown situations. The Vaccine Task Force itself had mainly been the brainchild of Sir Patrick Vallance, the UK government’s chief scientific adviser, who had seen the need “for a dedicated, nimble private-sector team of experts embedded in the Government to drive forward the development of vaccines for the United Kingdom and internationally”.Footnote 497 The new Vaccine Task Force was then installed under the Department for Business, Energy and Industrial Strategy in May 2020, and Kate Bingham was, as said, invited to chair it, reporting directly to the Prime Minister, alongside Vice President Clive Dix.Footnote 498

No one better than Bingham herself can explain the unorthodox (from a government’s point of view) approach she took in leading the Vaccine Task Force, which she described in a statement published in The Lancet:Footnote 499

The Vaccine Taskforce aims to ensure that the UK population has access to vaccines as soon as possible, while working with partners to support equitable access for populations worldwide, whether rich or poor.

(…)

Our strategy has been to build a diverse portfolio across different formats to give the UK the greatest chance of providing a safe and effective vaccine, recognising that many, and possibly all, of these vaccines could fail. We have focused on vaccines that are expected to elicit immune responses in the population older than 65 years: over three-quarters of deaths caused by SARS-CoV-2 infection are in this older population, so it is essential that any vaccine is able to protect this group. Scalability of vaccine manufacture was also a key criterion, with the goal being to manufacture in the UK, if possible, to secure supply and create long-term resilience.

(…)

The Vaccine Taskforce has now secured access to six vaccines (from more than 240 vaccines in development) across four different formats: adenoviral vectors, mRNA, adjuvanted proteins, and whole inactivated viral vaccines, which are promising in different ways. The most advanced vaccines, such as those developed by AstraZeneca and the University of Oxford, BioNTech and Pfizer, and Janssen, are based on novel formats for which we have little experience of their use as vaccines, although the initial immunogenicity and safety data are encouraging.

Vaccines based on frequently used vaccine formats, such as adjuvanted protein vaccines developed by Novavax, and by GSK and Sanofi, and inactivated whole viruses developed by Valneva, will not be available until late in 2021.

We also have an agreement with AstraZeneca to supply a neutralising antibody cocktail as a prophylactic treatment once clinical trials are completed and it is approved by regulators. This treatment will be provided in the short term for people who cannot receive a vaccine, such as people who are heavily immunosuppressed and cannot mount an immune response, or people who need immediate protection, such as health-care workers.

The Vaccine Taskforce has options to purchase sufficient doses of each vaccine type to vaccinate the appropriate UK population.

(…)

A major challenge is that the global manufacturing capacity for vaccines is vastly inadequate for the billions of doses that are needed, and the UK manufacturing capability to date has been equally scarce. The Vaccine Taskforce has provided funding for flexible and surge production in several new UK sites for vaccine manufacture to provide the UK population with a new vaccine in less than 9 months from the identification of the pathogen. We also plan to bring new vaccine technologies and capabilities to the UK for future pandemic preparedness.

No-one has ever done mass vaccination of adults anywhere in the world before and the two-dose regimen, plus cold-chain restrictions for some vaccines, adds to the complexity of this deployment operation. National Health Service England has flexible deployment plans to start the vaccination of prioritised cohorts as soon as the vaccines are approved by the regulatory authorities (…).

Bingham’s statement already indicates the huge difference about both approach and priorities, compared to the EU task force (cf. Sect. 9.4.3.3), as well as her much greater sense of reality.

The Bingham team, basically, behaved like a consumer who really wanted to acquire a scarce commodity, while the EU team had acted like a cumbersome administration that did not particularly care whether or not the Covid-19 vaccines would be acquired quickly, and who only seemed interested in bidding on the price.

Bingham herself commented on these differences as follows (in an interview with “Der Spiegel” of 18 February 2021):Footnote 500

Being quick and nimble was definitely important. The fact that I’ve been in the industry for 30 years and the team that I work with have been in the industry at least as long, if not longer, meant that we had connections very broadly across the industry. So that meant I could just pick up the phone and speak directly to a company. With one company we had our first meeting on a Thursday and we had a follow up meeting on Saturday, and would agree the rough outline of a deal the following week.

(…)

So we had to make ourselves good customers to make people want to supply to the UK because there was going to be limited amount of vaccine initially. Our goal was to do whatever we could do to encourage the companies to talk to us. That meant we had a sort of “UK offer”, as it were, which is if the company needed support in the scale of the manufacturing and fill finish and if we could offer that, we offered it and if the company needed us to help with running the clinical trials, we did that, too.

(…)

The UK had a very strategic approach, which was to secure vaccines quickly. And the European approach seems to be more sort of a more typical procurement approach, which was more about making sure you got the best value for money for your vaccines.

During the first hearing of 2021 of the Public Accounts Committee of the UK House of Commons on Monday 11 January 2021, Binghman added to this the following:Footnote 501

We talked about this in our report that was published in December. The conditions that the EU set to allow us to participate were conditions we felt were not attractive. We were not able to join any decision making on which vaccines; we had to abandon the negotiations we either had under way or had concluded with AZ; and we also were not able to talk to future potential vaccine companies that they may not be talking to currently, but would do in the future. We felt the conditions were too tight, and that we would be able to act more quickly if we did it independently. Equally, we remained very close and supportive, and continued discussions throughout to help them with their decision making and anything else that we could do. We just thought it was a better approach for us, and I think with hindsight that was the right decision, because we were able to secure the vaccines quicker and start vaccinating more quickly.

(…)

To nail your point about value for money, if we wanted the cheapest vaccines, we would have said that we would be happy to receive them in 2022. I have no idea how much cheaper they would be, but they would be cheaper, because what we wanted was the most scarce resource, which is the vaccines that were available as soon as they came off the production line in those early days. It is a trade-off to say, “What are the costs we’re paying?”, which are about £10 a dose. Again, I do not think that is excessive and it is in line with what we pay for flu. If we wanted to focus purely on price, however, which we did not, that would have been at the cost of the delivery date.

Shortly after the huge success of the Covid-19 vaccination approach that the United Kingdom had resorted to became clear, Bingham started being hailed as the “vaccine tsarina” by the British press, a term used in the United Kingdom to refer to people who are hired by the government to coordinate major social tasks. Another nickname she received was “Kate The Great”.Footnote 502

Her merits go without saying, most certainly in comparison to the disastrous consequences of the approach that had been applied by the EU vaccination purchasing team (cf. Sect. 9.4.3.9). Thanks to the efforts of Bingham and her team, the United Kingdom became the first country to sign a contract for the BioNTech-Pfizer Covid-19 vaccine, which ensured a quick launching of the UK vaccination campaign already at the end of December 2020. Although the United Kingdom was not the biggest buyer of Covid-19 vaccines when compared to the United States and the EU, Bingham and her team were able to act more skillfully and had better contacts in the industry. All the Western pharmaceutical enterprises Bingham and her team approached, were enterprises with which she herself or one or more members of her team had existing, good relationships, in one form or another. Bingham also brought with her what has been referred to as a best-practices habitus from the private sector: for the first few weeks after being installed, the Vaccine Taskforce worked around the clock and on weekends to identify the Covid-19 vaccine candidates with the best prospects of rapid regulatory approval. Bingham also insisted on speeding up the decision-making process. Throughout the whole proceedings of the UK Vaccine Task Force, Bingham acted on the feeling that she only had one chance to be right and no time.Footnote 503

Be this as it may, thanks to the extremely successful approach of the Bingham Vaccine Task Force, the United Kingdom succeeded to both launch and proceed with its vaccination campaign in a fast manner from the early start, which was welcome after the manner in which the UK government had responded to the Covid-19 crisis in general.Footnote 504 (Cf. Sect. 2.4.2.3.5.)

The success of the approach of the Bingham task force was in a symbolic manner validated on 8 December 2020, when the United Kingdom got to be the first country in the world to start serving a Covid-19 vaccine to its population.Footnote 505 The UK government later pledged that all adults living in the UK would be receiving a Covid-19 vaccine before the end of July 2021. This would imply that the United Kingdom would accomplish its vaccination campaign within less than eight months. Contrary to similar promises made by the EU, it moreover soon became likely that the United Kingdom would be able to live up to this promise. As, initially, the deadline had been late autumn of 2021, the fact that the United Kingdom got even ahead of schedule demonstrated the success of its Covid-19 vaccination campaign, which is to a large extent thanks to the professional approach of Bingham’s Vaccine Taskforce.Footnote 506

One of the main differences in approaches between the EU and the United Kingdom regarded their different purchasing agreements. While the purchasing agreements with AstraZeneca were superficially similar, the UK negotiators had nevertheless shown a much better insight in the production and supply chain of vaccines. As a result, the UK purchasing agreement contains an explicit clause in which it was stated that AstraZeneca was to ensure that the UK supply chain would be “appropriate and sufficient” for delivering the necessary doses of the Oxford-AstraZeneca Covid-19 vaccine to the country for guaranteeing a smooth vaccination campaign. This implied that in case that production in the UK plants would turn out to be insufficient for delivering vaccines to the United Kingdom at any time, AstraZeneca was bound to be getting the necessary doses from elsewhere in its global production network. In contrast, the purchasing agreement between the EU and AstraZeneca did not mention a similar clause. Other key elements in the purchasing agreement between the United Kingdom and AstraZeneca concerned clauses dealing with commitments of the suppliers of AstraZeneca and the willingness to invest in the development of the Covid-19 vaccine beforehand.Footnote 507 (Cf. Sect. 9.4.3.3) Another key factor that helps explain the high success rate of the UK approach is that the procurement strategy of the UK Vaccine Taskforce, contrary to the one of the EU, was based on rapid deliveries, rather than on the price of the vaccine doses.Footnote 508 As a result, already by December 2020, the United Kingdom had purchased enough doses of the approved Covid-19 vaccines to serve its entire population.Footnote 509

9.4.4.2 The Result: An Accelerated Vaccination Campaign

Based on early approvals of the Covid-19 vaccines by the Medicines and Healthcare products Regulatory Agency (abbreviated as “MHRA”), the United Kingdom started to administer Covid-19 vaccines as of December 2020.Footnote 510 The vaccination campaign proved to be highly successful from the early start, which explains why, already In February 2021, the UK government made the announcement that every adult living in the United Kingdom would be administered a first dose of a Covid-19 vaccine by the end of July 2021, which, as said earlier, was even one month earlier than had originally been intended.Footnote 511

On 3 March 2021, the United Kingdom reported that 20,982,571 people had received the first dose of a Covid-19 vaccine, while 20 million people had already been fully vaccinated.Footnote 512

By 6 March 2021, already more than 21 million people living in the United Kingdom had been administered at least one dose of a Covid-19 vaccine. On said date, the UK vaccination programme also entered the second part of its first phase. This implied that as good as all members of the first four priority groups—namely elderly people aged 70 and over, nursing home residents, healthcare laborers and those with special seclusion needs—had already been offered a Covid-19 vaccine. Around that same date, more than one million people living in the United Kingdom had also been administered a second dose of a Covid-19 vaccine.Footnote 513 By the same date of 6 March 2021, most regional parts of the United Kingdom had managed to serve high proportions of the population belonging to the priority age groups with a Covid-19 vaccine.Footnote 514

Until 6 March 2021, the United Kingdom had been relying on two Covid-19 vaccines that had obtained approval by the MHRA for its vaccination campaign. The BioNTech-Pfizer Covid-19 vaccine was the first to have been given the green light in December 2020. It, moreover, appeared that the doses of this vaccine used in the UK vaccination campaign were exclusively imported from Puurs, Belgium, while the Belgian population itself had at the time virtually no access to the BioNTech-Pfizer Covid-19 vaccine. The second Covid-19 vaccine that the UK vaccination campaign relied on was the Oxford-AstraZeneca one. The doses of the latter vaccine used in the United Kingdom were mostly manufactured in Britain by two biotech plants, namely Oxford BioMedica, based in Oxford, and Cobra Biologics, based at Keele Science Park, Staffs. Deliveries of a third Covid-19 vaccine, manufactured by the US enterprise Moderna, were expected to become available as of April 2021, with the doses to be delivered to the United Kingdom also stemming from EU production lines.Footnote 515

According to MedicalNewsToday, by 9 April 2021, more than 6 million people in the United Kingdom had been administered with both doses of one of the approved Covid-19 vaccines that require two doses. Some even started to hold that the United Kingdom was approaching herd immunity.Footnote 516 From an Opinium online survey of 2,006 adults conducted between 8 and 9 April 2021, it appeared that 44% of the respondents were approving of the UK government’s management of the Covid-19 pandemic, compared to 36% who disapproved. These were the best results since May 2020.Footnote 517

However, the UK vaccination campaign also had some drawbacks. E.g., according to a study published in The Lancet on 25 March 2021, there were huge inequalities in Covid-19 vaccine uptake. It more precisely appeared that people living in socio-economically deprived areas, in particular people belonging to certain ethnic minority groups, were less likely to obtain a Covid-19 vaccine. This was attributed to a number of reasons, including barriers to access and distrust of the authorities.Footnote 518

On 10 May 2021, England recorded zero daily deaths from Covid-19 for the first time since July 2020, a situation that was welcomed by experts who declared that it reflected the impact of the Covid-19 mitigation measures and of the Covid-19 vaccinations. In addition, at the same date, no Covid-19 related deaths were recorded in Scotland or Northern Ireland. However, four Covid-19-related deaths were still recorded in Wales. Experts such as Rowland Kao—a professor of epidemiology at the University of Edinburgh who was part of the Spi-M modelling subgroup of Sage, a scientific advisory group that dealt with emergencies—and Dr Michael Head, a senior research fellow in global health at the University of Southampton, declared that the drop in Covid-19 related deaths mainly reflected the impact of the Covid-19 vaccination campaign.Footnote 519

However, around mid-May 2021, a new concern arose as more and more cases of the Indian variant of the Covid-19 virus—known as B.1.617.2—started spreading in the United Kingdom, with scientists however at the time still expressing their belief that the Covid-19 vaccines remained effective against this variant.Footnote 520

9.5 Face Mask Wearing

It is clear that face mask wearing has been one the most important methods to help prevent the spread of Covid-19.

Universal face mask wearing thus became one of the prevention strategies that got recommended by the US CDC that indicated face mask wearing as an important method for slowing the spread of the Covid-19 virus. As a result, in the United States, on 1 February 2021, 38 states and the District of Columbia had mandated universal face mask wearing. Face mask use was also mandated by executive order on federal property, as well as on domestic and international transportation.Footnote 521 Similarly, the EU’s ECDC also recommended face mask wearing for the prevention of Covid-19, with several of the EU countries also having resorted to the measure.Footnote 522

Prior to the Covid-19 pandemic, the Western world had never showed much attention to the medical practice of face mask wearing for containing airborne viruses. Some even considered the effectiveness of community face mask wearing for reducing the spread of respiratory infections controversial, because there was, supposedly, no solid scientific evidence supporting its use.Footnote 523

However, during the Covid-19 pandemic itself, the scientific evidence on face mask wearing grew. There is convincing evidence (amongst others, collected in the United States itself) that community-based face mask use is an effective NPI (short for “non-pharmacological intervention”) for curbing the spread of the Covid-19 virus, particularly as a method to prevent further spread by contaminated individuals. A face mask, when properly used, prevents a contaminated wearer from passing the disease to others, and can also reduce exposure of the wearer to unknown carriers of Covid-19.Footnote 524 According to scientific research, face masks protect by significantly reducing that respiratory droplets and aerosols exhaled by contaminated carriers reach uncontaminated people, and by reducing the exposure of the uninfected to such particles.Footnote 525

Face mask wearing, however, comes with certain disadvantages. It has e.g., been acknowledged that prolonged face mask wearing can be uncomfortable, particularly in hot environments. It has also been recognized that blocking one’s nose and mouth may inhibit verbal and non-verbal communication, particularly for children and deaf people. Concerns about reduced oxygen intake and carbon dioxide retention have, however, not been confirmed by the available scientific data.Footnote 526

The overall benefit of face mask wearing to the community derives from its combined ability to limit both exhalation of the Covid-19 virus by infected people and inhalation of Covid-19 virus by uninfected people. Similar to the principle of herd immunity with regard to Covid-19 vaccination, the more the NPI—face mask wearing in this case—is resorted to by the larger community, the greater the benefit for all its members. Certain research even indicates that the general prevalence of face mask wearing in the community is of higher relevance than the type of face masks worn.Footnote 527 According to Brooks and Butler, when face masks are generally worn, and thus the more they are combined with other recommended NPIs, this does not only protect the individual wearers, but the community as a whole. This implies that even after vaccination, in light of the emergence of more transmissible variants of the Covid-19 virus (cf. Sect. 1.1.2), it remains important to continue widespread face mask use, as well other NPIs until sufficient levels of Covid-19 vaccination are achieved.Footnote 528

The supervisory health authorities have continued to monitor the practice and have issued (evolving) guidelines at several moments in time. E.g., one year after the start of the Covid-19 pandemic, on 10 February 2021, the CDC issued new mask guidelines based on a study of how mask fit affects the wearer’s exposure to airborne particles. It was thereby deemed important to explain how to use the right types of face masks correctly.Footnote 529 E.g., N95/FFP2 face masks were indicated as the gold standard among lightweight respirators, indicated as being at least 95% efficient at filtering out particles as small as 0.3 microns and more than 99% efficient for particles between 2 and 5 microns.Footnote 530 Medical masks—specifically ASTM F2100-19 Class 1 masks, the blue or green paper face masks seen everywhere—were indicated of being about 80% effective. Cotton masks were indicated as providing some protection, but of being of no help in blocking small aerosols.Footnote 531 On 13 May 2021, the CDC, furthermore, announced new guidelines for face mask wearing for fully vaccinated individuals.Footnote 532

9.6 Conclusions

9.6.1 The Good, the Bad and the Ugly

Like so many events which occurred during the Covid-19 pandemic, the turnout of the Covid-19 vaccination campaigns as of December 2020, presents one more illustration of how the logic of capitalism and neoliberal public policy—combined with conservative, nationalistic reflexes—can turn something intrinsically ”good”, into something “bad” and “ugly”.

Indeed, the way the Covid-19 vaccination campaigns in the West proceeded as of December 2020, can even be referred to in terms of the three title words of one Sergeo Leone’s western movie, “The good, the bad and the ugly”.

First, came the good: Reference is, obviously, made to the hard work of scientists, from various disciplines, who made the study of (corona)viruses and/or vaccines their life’s work. Because of their efforts, research into new coronavirus vaccines was already in an advanced stage at the time of the outbreak of Covid-19 (cf. Sect. 9.3.1.1): several of the Covid-19 vaccines were made ready for use in less than a year after the outbreak of the Covid-19 pandemic (namely already in early-December 2020).

Second, came the bad, notably the pharmaceutical sector: Once a drug is patented by them, the capitalist game is as good as played, and the winner clear. Indeed, a pharmaceutical patent, by definition, implies that the production of a patented drug is monopolized by the patent holder for a considerable period. The fact that a drug, in this case a Covid-19 vaccine, may save millions of lives, and could even put an end to a pandemic, is of no relevance under the logic of the free market. In the eyes of a patent holder—in full accordance with the capitalist principles underlying such patents -, a patented drug is just one more method of maximizing short-term, private profits—ultimately to the benefit of the shareholders of the big pharmaceutical enterprises owning the patents. (Cf. Sect. 9.2.3.)

In the years preceding Covid-19, the pharmaceutical sector had already been discredited a number of times because of its blind devotion to the harsh logic of capitalism,Footnote 533 but probably never so much as during the Covid-19 crisis. The main consequence of this “bad” guy’s working methods has been that the Covid-19 vaccines—although to a large extent based upon technology developed by largely government-funded academic scientists (cf. Sect. 9.2)—were only available through buying them at high prices from the few private pharmaceutical enterprises that own the patents necessary for producing the actual vaccines. With hospitals overwhelmed and fatalities on the rise, some of the vaccine producers made it explicitly clear that they had no intention of relinquishing their patents, indicating that whoever wanted Covid-19 vaccines, had to come and buy them at high prices.Footnote 534 The billions in public funding were not even taken into consideration, as is common under capitalist and neoliberal logic. It should also be noted that these aforementioned amounts, pointed out in Sect. 9.2, are just the tip of the iceberg, as the real contribution of the public sector to the development of such drugs is undoubtedly much higher. E.g., there is also the societal cost of organizing general education, and every other societal effort and public investment that goes into enabling talented individuals to become proficient enough in medical science to create such vaccines in the first place.

As a result, once the Covid-19 vaccines were ready at the end of 2020, they were only accessible on the terms of the capitalist, and made subject to the principles that govern every form of industrial production and commercialization, particularly: (1) Ownership/proprietorship (through patents) by private companies, who (2) maximise their profits through sales, and (3) then distribute their—gigantic—profits to their private shareholders by means of dividend payments or share buyback operations (whatever is the most interesting tax-wise).

Third came the ugly. In our Covid-19 vaccination debacle, this role was reserved for the EU, and more specifically its overbearing reliance on a neoliberally inspired stinginess in procuring the Covid-19 vaccines.

From the foregoing, we know that “the good” in our Covid-19 vaccination story—namely an invention that could have enabled mankind’s rapid rescue from a pandemic–, due to the working methods of capitalism, soon came into the hands of “the bad”, the pharmaceutical industry who soon managed to foreclose access to the Covid-19 vaccines by means of medicine patents, in such a manner that those in need of the Covid-19 vaccines, i.e., practically every country in the world where the Covid-19 pandemic was raging, first had to put the necessary amounts of money on the table to pay for them. Indeed, like everything in the free capitalist markets, products go to those who are willing to pay the highest price for them, so also the Covid-19 vaccines. It was, moreover, not entirely clear how this related to statements from e.g., the part of Covid-19 vaccine producers Johnson & Johnson and AstraZeneca that they would make their vaccines available on a non-profit basis. (Cf. Sect. 9.2.)

And thus, already throughout 2020, it happened: Countries that wanted Covid-19 vaccines, had to knock on the doors of the private vaccine manufacturers, and make their purchasing bids known. Some countries, such as the United States, the United Kingdom and Israel, very quickly acknowledged this basic truth—to the extent that it was really not hard science, but simply one the basic premises of capitalism—and acted on it. The EU, however, had been blindly adhering to the dictates of neoliberal thinking, at the very least since 1992, and had never shown much willingness to deviate from them for the good of common people. No lessons had been drawn from the free market-induced 2008 financial crisis, and, in a similar manner, the EU also kept its disastrous course when a pandemic was keeping the entire world in its grip. Especially for the EU, issues such as public health and human lives are but secondary to upholding neoliberal logic, as we have already seen in Chaps. 5 and 6, when we dealt with what went wrong in the neoliberalized sectors of the hospitals and long-term nursing homes respectively, in the decade prior to the outbreak of Covid-19. Under severe, neoliberal austerity logic, governments should spend as little as possible for the general good, and certainly not overspend on something like public health.Footnote 535 Regretfully, we have all been able to witness the outcome of this approach during the first half of 2021: while certain countries (e.g., the United States and the United Kingdom, among other countries, but with Israel taking the lead) secured massive access to the Covid-19 vaccines, the EU—and with it many other countries—remained largely in the cold (at least until the United States would have been served completely). By the end of March 2021, this had resulted in a two-speed vaccination policy, whereby vaccination campaigns in a limited number of countries were proceeding at high speed, while in other countries, including the member states of the EU itself, almost no progress whatsoever could be made due to a shortage of vaccines.

Finally, there was also a large group of (poor) countries who did not have the financial means to make purchasing bids themselves, but became entirely reliant on initiatives the likes of COVAX and/or on donations from rich countries or vaccine producers themselves, implying that they had hardly any vaccines available at all …

Capitalist principles (as deployed by private market players), in combination with neoliberal austerity policy on one continent and conservative-nationalist—“we-first”—policies in other countries, made something inherently “good” intrinsically “bad” at lightning speed, and “ugly” neoliberal public policy managed to make things even worse.

9.6.2 Vaccine Nationalism

As a result of the capitalistic forces described in the previous Sect. 9.6.1, the way vaccination campaigns started rolling as of December 2020, soon became the triumph of “vaccine nationalism” with the three most “exemplary countries”—namely Israel, the United States and the United Kingdom—basically only reasoning for themselves, in contrast to the EU.Footnote 536

Already in December 2020—unlike the EU–, the United States and the United Kingdom had decided to hardly export any of their vaccine-production.Footnote 537

Globally, as of 25 March 2021, the number of Covid-19 vaccine doses administered per 100 people amounted to 6.5. There were, however, significant differences across countries and continents. There were, e.g., 115 doses of a Covid-19 vaccine per 100 people administered in Israel, and only 35 and 15 doses per 100 people in the United States and the EU respectively. Asian countries had on average administered 4.5 doses per 100 people, mainly because of a huge Covid-19 vaccine production and administration in India and China. With regard to the African continent, there were either no data available, or, in countries for which there were data available, there were no Covid-19 vaccines administered at all.Footnote 538 By 27 April 2021, already 25% of Americans had been fully vaccinated. In contrast, in Ghana, less than 2% of the population had been administered a Covid-19 vaccine. Within Israel itself, an Israeli was reported to be 20 times more likely to have been administered a dose of a Covid-19 vaccine than a Palestinian. Even apart from the exceptional situation in Israel, there were still many other inequalities prevailing within several other countries, partly because of Covid-19 vaccine hesitancy. This was, e.g., in particular the case for the United States. (Cf. Sect. 9.4.2.6) Probably because there had been few Covid-19 contamination cases and deaths in Hong Kong, people living there reportedly stayed away from Covid-19 vaccine centres in huge numbers, a phenomenon that became referred to as the “prevention paradox”.Footnote 539

In the meantime, the COVAX facility—short for “Covid-19 Vaccines Global Access”—had been activated. This facility was intended to counteract vaccine nationalism, with as overall aim to get a first Covid-19 vaccine dose administered to at least one fifth of the global population by the end of 2021, though by 27 April 2021, this stated goal was far from achieved.Footnote 540 In contrast, by 9 April 2021, high-income nations, only representing 14% of the global population, were together controlling up to 53% of the global supply of the promising Covid-19 vaccines. This meant that the high-income countries possessed 100% of the Moderna Covid-19 vaccine supply and 96% of the BioNTech-Pfizer Covid-19 vaccine supply.Footnote 541

Basically, some rich countries, mainly the United States and the United Kingdom, besides a number of oil producing countries, had made use of their huge economic and political muscle to hoard as many Covid-19 vaccine doses for the exclusive benefit of their own population as possible, while the poor nations had to count on the COVAX initiative, and on institutions such as UNICEF, GAVI and WHO for defending more equitable access.Footnote 542

Notwithstanding these initiatives, Covid-19 vaccine inequity already started with production, to the extent that only some socio-economic and political superpowers had managed to have pharmaceutical enterprises producing Covid-19 vaccines in their territories.Footnote 543 In addition, production remained largely constrained, as most pharmaceutical enterprise refused to share the knowledge and technology to make Covid-19 vaccines, with intellectual property rules, furthermore, preventing other countries from creating their own generic versions of the Covid-19 vaccines. This implied that the whole world was dependent on the limited supply chains of a few patent-holding enterprises. Because of this impediment, just a fraction of the world’s pharmaceutical manufacturing capacity got effectively deployed against the pandemic.Footnote 544

Figure 9.6 gives a general overview of the status of vaccine production in some countries as of 17 March 2021.

Fig. 9.6
figure 6

Vaccine production by country as of 17 March 2021 [Source: Axios (2021)]

The foregoing relates to the matter which countries had been both technically capable of developing Covid-19 vaccines and capable and willing of throwing big money at the pharmaceutical enterprises in order to finance the rapid development of the Covid-19 vaccines. E.g., already on 15 December 2020, The New York Times reported that the United States had been giving billions of dollars to back the research, development and production of five of the most promising Covid-19 vaccine candidates. This had allowed researchers to proceed with the Covid-19 vaccine development at an unprecedented speed and scale. (Cf. Sect. 9.2) While it was generally perceived that without his huge financial support, the Covid-19 vaccines would not have been developed so quickly, this came at a cost, namely that Americans would have priority access to the Covid-19 vaccine doses developed or produced in their country.Footnote 545 Soon, other wealthy countries started following the early example of the United States in placing large Covid-19 vaccine pre-orders that, moreover, often contained contractual options to expand the acquisitions even further, in this manner even more undermining other countries’ capacity to make timely purchases for themselves. E.g., already by 15 December 2020, the United States had secured 100 million doses from the BioNTech-Pfizer Covid-19 vaccine, with a contractual option of buying 500 million more doses of the vaccine. In a similar manner, the United States had already purchased 200 million doses of the Moderna Covid-19 vaccine, with an additional 300 million under option. And if this was not enough, the United States had also managed to pre-order 810 million doses from the AstraZeneca, Johnson & Johnson, Novavax and Sanofi Covid-19 vaccines combined, in many cases with no clear intention for ever using these alternative vaccine doses. It was, moreover, pointed out that expansion deals that the United States had concluded by that same date allowed it to push the number of “other” Covid-19 vaccines to 1.5 billion. The United Kingdom had in a similar manner already claimed 357 million doses from all of these Covid-19 vaccine producing enterprises, along with some additional doses of a small enterprise named Valneva, with options to buy an additional 152 million doses of the Covid-19 vaccines. Also by 15 December 2020, the EU had managed to secure 1.3 billion doses of Covid-19 vaccines from most of the same vaccine producing enterprises, besides the German enterprise CureVac. The EU, moreover, had options for acquiring an additional 660 million doses.Footnote 546

With specific regard to the BioNTech-Pfizer Covid-19 vaccine, it was clear that, in the period between December 2020 and April 2021, deliveries of the vaccine had been disproportionately reaching the world’s rich countries, while hardly any doses had been shipped to poorer countries.Footnote 547 By mid-April 2021, based on data provided by the WHO, it was indicated that high-income countries had been receiving around 87 percent of the more than 700 million doses of the Covid-19 vaccine that Pfizer had managed to deliver worldwide, while poor countries had only received about 0.2 percent of these deliveries. In high-income countries, roughly a quarter of the people had been administered with a shot of the Pfizer Covid-19 vaccine. In poor countries, this figure only amounted to one in 500. Nevertheless, Pfizer kept declaring that it remained committed to ensure that its Covid-19 vaccine would be made available everywhere and accessible to anyone.Footnote 548

According to Ravi, the unequal distribution of the Covid-19 vaccines, once more, exposed the neglect of the world’s poor, who were said to be “routinely deprived of basic human rights, in general, and justice, in particular”.Footnote 549

All of this raised increasing concerns of “vaccine apartheid”, indicated as a stark inequality in global access to the Covid-19 vaccines. All of this came, moreover, down to the fact that, while some high-income countries had been able to roll out massive Covid-19 vaccination drives following a fast development, production and emergency authorization of multiple Covid-19 vaccines, poorer countries saw no hope of gaining access to any of the Covid-19 vaccines in the near future.Footnote 550

According to Bhattacharjee, if Covid-19 has taught the world anything, it is that the Western emphasis on human rights is downright farcical. At a time—more precisely on 23 April 2021—when India was suffering a tragedy dealing with the Covid-19 pandemic, western countries did nothing but offer sermons and lectures, instead of sympathy and real support. Bhattacharjee, e.g., made reference to a statement of German Chancellor Angela Merkel who, amidst the second wave of the Covid-19 pandemic that hit India beyond all proportion, had said that there were concerns that India would not be able to meet pharmaceutical demands in Germany, which would make the latter country to have to ‘rethink’ their policies should that be the case. Merkel was quoting having said the following:Footnote 551

Of course, we have only allowed India to become such a large pharmaceutical producer in the first place, also from the European side, in the expectation that this should then also be complied with. If that is not the case now, we will have to rethink.

Regretfully, Germany was not the only country that had been making such insensitive remarks. The United States was at the time enforcing an embargo on the export of raw materials essential to produce Covid-19 vaccines, which jeopardized vaccine production in India. The CEO of the Serum Institute of India (SII), Adar Poonawalla, had even explicitly appealed to the Biden administration to lift said embargo, but to no avail. When asked about the matter, State Department spokesperson Ned Price had simply replied that the US government has a special responsibility to the American people. The Western media, which had before demonized India over its nationalist concerns (namely that it would not allow the export of Covid-19 vaccines produced in factories on its soilFootnote 552), did not see any hypocrisy in the approach of the United States and kept its silence on the matter.Footnote 553

These approaches are completely logical under the dictates of neoliberal capitalism, which gladly embraces caring for oneself to the detriment of the other. They are however incompatible with the solidarity required for a civilized world-order and undermine efforts to effectively respond to the global health-crisis that is Covid-19. With such an approach, it was unlikely that the core problem caused by the Covid-19 pandemic would ever be solved.Footnote 554

Indeed, vaccine inequity only reinforces the existing disparities between health and economic well-being. WHO Director-General Tedros Adhanom Ghebreyesus has in this regard expressed his huge concern that because of inequities in immunisation, “[t]he world is on the brink of a catastrophic moral failure, and the price of this failure will be paid with lives and livelihoods in the world’s poorest countries.”Footnote 555

The best way for illustrating this simple truth is by referring further to the disastrous events that were taking place in India in April 2021, with media all over the world reporting that the Indian health system had completely collapsed, while only a small fraction of the Indian population had already been administrated a dose of a Covid-19 vaccine.Footnote 556

By 9 April 2021, it was estimated that at the then current global rate of 6.7 million doses of the Covid-19 vaccines per day, it would take approximately 4.6 years to achieve global herd immunity, which implied that there would be millions of additional infections and deaths. In the case of Covid-19, it was estimated that herd immunity would be achieved when 70–85% of the global population would have been administered two doses of a Covid-19 vaccine. By the said date of 9 April 2021, experts however estimated that 80% of people in low-income countries would not have received the vaccine by the end of 2021. Other estimates suggested that it was unlikely that at least 90% of the population in 67 low-income countries would have been administered the Covid-19 vaccine by the end of 2021.Footnote 557

According to an article in The Economist on 27 January 2021, widespread immunisation coverage in developing countries was not likely to be reached before 2023, if ever at all.Footnote 558

The economic reality is that there were/are simply too few Covid-19 vaccines available to serve everyone. In pre-Covid-19 times, 3.5 billion vaccine doses were produced annually, e.g., against measles. Because of Covid-19, there was, suddenly, an urgent demand for 15 billion vaccine doses, preferably immediately. Although the few pharmaceutical enterprises that had a Covid-19 vaccine prepared were doing their best to increase production, upscaling still went far too slow.Footnote 559

In this time of need, the United States was basically instigating a harsh and false competition between the interests of its citizens and that of the rest of the world. What was completely incomprehensible were the (initial) western efforts to block a request by India, South Africa and other developing countries to suspend intellectual property rights over the vaccines for the immediate future. Such a waiver of IP rights would have allowed developing countries to ramp up Covid-19 vaccine production to meet both domestic and foreign demands. As a result, developing countries such as India were by April 2021 faced with a situation where the United States even started blocking raw materials required for vaccine production, while other western countries were blocking requests for an IP waiver. On top of that, countries such as Germany were even issuing thinly veiled threats.Footnote 560

This all helps to explain why the scarcity problem should have been solved differently from the early start, e.g., via international planning and strategy. This method should then not only have applied to states, but also to large pharmaceutical enterprises, that should have automatically released their IP rights, or at the very least started cooperating with competitors in efforts to attain joint production, based upon models of cheap and far-reaching licensing. It is clear that the efforts of both states and pharmaceutical enterprises in this regard have been completely insufficient.Footnote 561

There was, obviously, no magic solution. Producing a vaccine is complex, requiring more than just exchanging a formula of ingredients. It also implies the exchange of a lot of additional know-how, which necessitates that releasing IP rights should go hand in hand with an intense cooperation between pharmaceutical enterprises. Nevertheless, from the part of the governments, the lifting of patent rules could in itself have been a way for the political world to finally withdraw from the strong hold of the pharmaceutical sector. It could also have been a lever to force pharmaceutical enterprises to at least try and start cooperating more with each other and with others. And by lifting or easing on patents, another injustice could have been corrected: in 2020, numerous governments had given several pharmaceutical enterprises substantial financial injections to finance the search for a Covid-19 vaccine candidate. But, to the annoyance of the WHO, no conditions were set in return to ensuring global access to these vaccines, which afterwards became one more factor explaining the excess in some countries and the shortages in others.Footnote 562 (Cf. Sect. 9.2.2.)

This is how, according to Goossens, at the beginning of 2021, the world ended up “in the subterranean dynamics of vaccine nationalism”, making it almost impossible for politicians to resist “that capitalistic monster”. Harried by impatient populations—and after Israel, the United States and the United Kingdom had throughout the period from December 2020 until April 2021 “practically cleared the shelves of the vaccine shops”–, many other countries, especially EU Member States, had simply started grabbing whatever was left, even threatening to start a dangerous game of export prohibitions that could have led to mutual blockages, while most developing countries, for the time being, ended up with nothing.Footnote 563 (Cf. Sect. 9.4.3.10.)

There is a further concern which makes it unlikely that one country would in the long run be successful in beating Covid-19 on its own, namely that further mutations (variants) of the Covid-19 virus may be resistant to the Covid-19 vaccines that have thus far been created. The whole vaccination circus would then have to start all over again. Governments would again have to pump fortunes into research departments and pharmaceutical to design and produce new vaccines. It is uncertain if this new drive would have the same success as the last one, but we can rest assured that, in complete correspondence to the dictates of (neoliberal) capitalism, the pharmaceutical giants will once again be the big financial winners of such a continued game, unless, at last, the rules of the game are changed.Footnote 564

According to Tran, nationalism, and competition over the Covid-19 vaccines—in addition to numerous other forms of irrational and nationalist behaviour, ranging from acrimony between countries over China’s early handling of the viral outbreak to a general lack of cooperation in investigating the origin of the Covid-19 pandemic—all contributed to the delayed and uncoordinated rollout of the Covid-19 vaccines around the world. This slow and totally uneven distribution of vaccines, in this manner, prolonged the Covid-19 pandemic itself, and, as illustrated before, risks prolonging it even more.Footnote 565

9.6.3 Calls for an Alternative Approach

In spring 2021, in the midst of all of this confusion and debate—and, moreover, in complete opposition to the basic, neoliberal working principles that usually determine EU public policy—EU Commission chairwoman Ursula von der Leyen all of a sudden declared that Covid-19 vaccines were to be viewed as “a global common good”, even as powerful players such as the newly elected US President Joe Biden seemed content to simply continue the “America first”-policy that had been initiated by his predecessor, Donald Trump.Footnote 566

The argument that Covid-19 vaccines should be treated as a “global commons” had already been made before by several other individuals and institutions, such as the People’s Vaccine Alliance, founded in 2020 as a coalition of organisations and activists united under a common goal of campaigning for a “people’s Covid-19 vaccine”, based on shared knowledge and available free to all and everywhere as “global commons”.Footnote 567

The People’s Vaccine Alliance more in particular identified the following elements to achieve such a goal, which we have summarised in a list of concrete action points:Footnote 568

  1. (1)

    Pharmaceutical enterprises should share knowledge and abstain from enforcing IP rights in the interest of public health.

    It is hereby considered particularly important that pharmaceutical enterprises and research institutes would start sharing knowledge, know-how, people, biological material and technology for producing the Covid-19 vaccines with other enterprises, especially those that have the capacity for manufacturing them as well.Footnote 569

  2. (2)

    Given that there is a pandemic occurring and that most of the research and development (R&D) expenses for developing the Covid-19 vaccines were financed through public funding resources, it is completely unacceptable for enterprises to monopolise the Covid-19 vaccines and to charge the excess prices that they have started to charge as of 2020 (cf. Sect. 9.2.3). E.g., the high prices charged by BioNTech-Pfizer and Moderna put their Covid-19 vaccines beyond the reach of all but the richest countries.

  3. (3)

    As the development of most of the Covid-19 vaccines (and other forms of treatment to deal with Covid-19) have been funded out of taxpayers’ money, governments should start imposing conditions on their funding, such as the removal of patents and other IP barriers, the open sharing of knowledge and the transfer of technology to as many producers all over the world as possible.

  4. (4)

    The objective of public policy should be to maximise a fast and global supply of the Covid-19 vaccines (and other treatments), rather than aiding to maximise the profits of the private pharmaceutical enterprises. This, obviously, implies that some of the most fundamental working principles of capitalism would be abandoned, or at the very least diminished.Footnote 570

  5. (5)

    Covid-19 vaccines, tests and treatments all have to be provided at transparent and affordable prices, so that all governments and donors around the globe can afford buying enough of them to provide them free of charge to their entire population.

  6. (6)

    A more equitable and efficient system is needed for the distribution of Covid-19 vaccines (but also for other drugs for treating Covid-19, as well as for PPE), and should prioritize people at risk in all countries.Footnote 571 E.g., Covid-19 vaccines should be distributed according to the needs of priority groups, rather than sold to the countries that are able to pay the highest price.

  7. (7)

    Governments and pharmaceutical enterprises both share a responsibility to increase people’s willingness to be vaccinated against Covid-19. To achieve this, governments have a duty to put science before politics, in order to build a sufficient degree of trust among their population. Pharmaceutical enterprises and research institutes for their part must contribute to building this trust by always ensuring transparency in terms of the results of clinical trials, safety and efficacy data, costs and prices.

According to Tran, it is in all of this equally important that the general public would continue to put pressure on their leaders to learn the lessons of the Covid-19 pandemic and to strive to perform much better in the future.Footnote 572

9.6.4 A Surprising Response from US President Joe Biden

On 5 May 2021, US President Joe Biden surprised the world by expressing his support for waiving IP rights for Covid-19 vaccines. It was reported that in doing so, Biden had bowed to the mounting pressure from both Democratic lawmakers and more than 100 other countries, while at the same time angering various pharmaceutical enterprises.Footnote 573 Amid growing concerns that large outbreaks of Covid-19 in IndiaFootnote 574 at the time could lead to vaccine-resistant strains of the deadly Covid-19 virus, which threatened to jeopardise the global recovery, Biden became more cautious in favour of a temporary IP waiver—a dramatic reversal of the previous US position.Footnote 575 This had, more in particular, become clear from a speech at the White House, followed by a formal statement from Biden’s chief trade negotiator, Katherine Tai.Footnote 576 In the latter statement, Tai stressed that the global health crisis and the extraordinary circumstances of the Covid-19 pandemic called for extraordinary measures.Footnote 577 Tai also announced that the United States would continue to push for increased Covid-19 vaccine production and distribution on a global scale.Footnote 578

Of course, this realisation came to the US head of state only after (1) the United States had ensured that it had first captured a sufficient stock of the mRNA and other Covid-19 vaccines to serve the entire US population; (2) a large proportion of the US adult population had already received at least one dose of a Covid-19 vaccine, and (3) there was even talk of administering the Covid-19 vaccines to US children and youth (notwithstanding the fact that the risk of Covid-19 for children and young people is very low, and in most other countries, even risk groups and healthcare providers had not yet been served). In this sense, the American conscience only began to awaken after the “Americans First” principle had been fully satisfied.

Following President Biden’s announcement, the shares of a number of Covid-19 vaccine producers sharply fell.Footnote 579 However, Biden’s decision was welcomed by WHO chief Tedros Adhanom Ghebreyesus, who on Twitter referred to it as “a monumental moment in the fight against Covid-19”.Footnote 580 Biden’s statement was meant to pave the way for what could be months of negotiations to work out a specific exemption plan, as WTO decisions require a consensus of all 164 members.Footnote 581 From her part, Helen Clark, head of the expert panel reviewing the WHO’s handling of the Covid-19 pandemic and former Prime Minister of New Zealand, called on countries that had been blocking the temporary suspension of IP rights with regard to Covid-19 vaccines, such as the United Kingdom, Switzerland and some EU Member States (cf. Sect. 9.6.3), to follow the American lead and support the initiative as well.Footnote 582 Helen Clark, furthermore, proclaimed that pharmaceutical enterprises should recognise that the Covid-19 vaccines are a public good and urged them to cooperate or to brace themselves for a “tough” treatment. Clark also indicated that the WHO and the WTO had to start urging countries that had been funders of Covid-19 vaccine research and pharmaceutical enterprises that had been on the receiving end of such funding, to reach an agreement on early voluntary licensing and transfer of technical knowledge. The Gavi Vaccine Alliance, similarly, welcomed President Biden’s support for the abandonment of IP rights and urged Washington to ensure that vaccine producer would start to transfer their know-how to boost global Covid-19 vaccine production.Footnote 583

The next day, on 6 May 2021, European Commission President Ursula Von der Leyen declared that after initially having remained cautious about abandoning IP protection with regard to Covid-19 vaccines, the EU was ready to discuss the matter with the White House further.Footnote 584 Similarly, French President Emmanuel Macron announced that he was “absolutely in favour” of the plan. Macron’s support for the US initiative had marked a shift for France, which had previously argued that a waiver of IP protection, such as patents, would discourage innovation. Meanwhile, a German government spokesman declared that the plan would create “serious complications” for the Covid-19 vaccine production.Footnote 585 Gordon Brown, former British prime minister, UN global ambassador and leader of the campaign for equal access to the Covid-19 vaccines, welcomed the US decision to temporarily waive patents as it would make Covid-19 vaccines available. UK Shadow Foreign Secretary Lisa Nandy and Shadow Trade Secretary Emily Thornberry similarly welcomed President Biden’s move.Footnote 586

9.6.5 And Furthermore …

Although the Covid-19 crisis has brought to light numerous problems caused by neoliberal capitalism, probably none of them has caused more turmoil than that of unequal access to Covid-19 vaccines. (Cf. Sect. 9.6.2.)

Nevertheless, if we are to follow the working methods of neoliberal capitalism, there could hardly have been any controversy. The Covid-19 vaccines, after the technology to make them had been developed at universities and/or with government support elsewhere, were—via patents—neatly placed in the hands of a number of pharmaceutical enterprises, from where they were then sold on—entirely according to the dictates of capitalism—to those who needed them. That the pharmaceutical enterprises aspired to usurious profits, destined afterwards to be granted to their shareholders, was hardly to be blamed on them, to the extent that in doing so, they behaved exactly as capitalism demands of them.

Nevertheless, after this “normal state of affairs” had quietly run its capitalist course in the period from December 2020 to March 2021, serious questions gradually arose, as the consequences of applying capitalist logic to public health became clearer and clearer. By April 2021, while a hellish second wave of Covid-19 erupted in India and the media started to show harrowing images of burned bodies on the streets of Indian cities, even some fervent defenders of neoliberal ideology finally started to feel a twinge of conscience (or perhaps a fear of escalation), which shifted the political debate on releasing the patents on the Covid-19 vaccines into higher gear at the WTO.

Obviously, as long as capitalism (and the neoliberal ideology that maintains it) will prevail, these problems may never be truly solved.

Precisely for this reason, already in various of our earlier work,Footnote 587 we called for a fundamental rethinking of the working principles on which the economy is to be based, and of the legal methods for shaping it. One approach could be to thoroughly moderate enterprises, where the pursuit of profits should no longer be their main objective but would make way for more sustainable business models. Similarly, business should no longer aim at unbridled wealth creation to the exclusive benefit of a couple of happy few shareholders.Footnote 588 On the contrary, states could, e.g., start setting maximum caps on private wealth accumulation, where, once the maximum cap would be reached, any excess income would simply be taxed away.Footnote 589 The mere application of such an approach to the pharmaceutical industry might have been able to alleviate much of the suffering caused by Covid-19.

Personally, we would like to see the reforms go even further and, in line with our earlier proposals, see the world work towards a universal basic health system in which what went wrong during 2020–2021, could never happen again. Vaccine policy, too, could then be framed within such a universal health policy (the contours of which we have already outlined in more detail in the conclusions to Chaps. 5 and 6, to which we therefore refer here) (cf. Sects. 5.5.2 and 6.3).

Notes

  1. 1.

    Hu et al. (2021).

  2. 2.

    Hu et al. (2021).

  3. 3.

    Hu et al. (2021).

  4. 4.

    https://biorender.com/covid-vaccine-tracker (as accessed on 24 March 2021).

  5. 5.

    https://biorender.com/covid-vaccine-tracker (as accessed on 24 March 2021).

  6. 6.

    Byttebier (2019), p.33.

    Already some of the most ancient philosophers such as Plato and Aristotle had warned that in their times, the “pursuit of profits” was becoming one of the main motives, if not the only one of the (already in their times gradually emerging) class of merchants, and both philosophers had urged that society should best abstain from allowing this pursuit of profits principle becoming too dominant. (For further details, cf. Byttebier (2017), p. 91 a.f.; also Byttebier (2019), p. 33.) Similarly, ancient religious systems, amongst which early Christianity, also came up with severe moral rules against the unbridled pursuit of profits. (For further details, cf. Byttebier (2017), p. 94 a.f.; cf., furthermore, Byttebier (2019), p. 33.)

    Under the influence of these philosophical and religious doctrines, at least in the so-called West, the (early) Medieval society, which to a large extent was based on religious rules imposed by the Catholic Church, for a long time (i.e., more or less a millennium) succeeded in both slowing down the breakthrough of the pursuit of profits as a leading societal principle and preventing the class of merchants of becoming the main dominant societal force. However, already in the Middle Ages, the class of merchants, to a growing extent, aimed at escaping this religious scrutiny in practice. During a long period of time, this would be done in clear opposition to the teachings of the Church (as based upon the Words of Jesus Christ Himself). By the end of the Middle Ages, the resulting dualistic attitude towards wealth hoarding behaviour of the class of merchants would become one of the theological discussion points that attributed to the schism of the Protestant churches. Unfortunately, also the leading scholars of Protestantism failed in establishing a clear approach on the subject. As a result, Protestantism even started showing more leniency towards wealth hoarding behaviour than Catholicism had ever been willing to do, which helps explaining that pre-capitalist practices broke first through in the Protestant territories, such as the German territories in the sixteenth Century and Holland and the English territories, next to their respective overseas colonies, as of the seventeenth Century. However, the true turnabout of the societal value scale that would condemn humanity to capitalism, would not be caused by religious doctrine, but rather by (a) laymen’s doctrine(s) that later in history would become known as the school of “(economic) liberalism”. More precisely, in the approach of Adam Smith, it was held that society’s interests are not best served by adhering to an altruistic way of life, but rather by the development of an essentially selfish lifestyle. In this way, Smith was one of the first to proclaim that man should mainly (if not only) pursue his own selfish interest(s), without questioning the impact of such behaviour on others. In the long term, and as if it were guided by an “invisible hand”, a society where every individual mainly looks after himself, is believed to evolve into the most prosperous society that will optimally accommodate the interests of all those who are part of it. (Cf., furthermore, Byttebier (2019), p. 34–35.) Through this, Adam Smith’s teachings gradually succeeded in identifying the pursuit of economic self-interest of the individual with the public good. Ultimately, the domain of the public good would thus become entirely subordinated to the economic interests of the rich and powerful (cf. Byttebier (2019), p. 36.)

  7. 7.

    Galbraith (1983), pp. 112–113.

  8. 8.

    A perfect illustration in the context of the development of the Covid-19 vaccines, is the life story of Katalin Kariko, as reported about by Kolata in an article that appeared in The New York Times. (Cf. Kolata (2021).)

    According to this article, Kariko spent her childhood and youth in Hungary, in the small Hungarian town of Kisujszallas, as the daughter of a local butcher. Already at a very young age, Kariko had decided that she wanted to be a scientist. Kariko obtained her Ph.D. at the University of Szeged and was then employed there as a postdoctoral fellow at the Biological Research Center. In 1985, when the university’s research program ran out of money, Kariko, then in her 20s, together with her husband and 2-year-old daughter (Susan), decided to move to Philadelphia, in the United States, where she had managed to obtain a function as a postdoctoral researcher at Temple University. In the decades to follow, Kariko never managed to obtain a permanent academic position in the United States as well, but instead functioned at the fringes of academia. However, by 2021, Kariko had emerged as one of the key researchers of Covid-19 vaccine technology. The work of Kariko and that of one her former close collaborators, Dr Drew Weissman of the University of Pennsylvania, had more in particular the foundation for the extremely successful mRNA-based vaccines developed by Pfizer-BioNTech and Moderna. (Cf. Kolata (2021).)

    Kariko had during her entire career been working on the development of so-called messenger RNA, or abbreviated mRNA—basically a genetic script that carries DNA instructions to cell’s protein-making machinery. Kariko was of the opinion mRNA could be used for instructing cells to make their own medicines, including vaccines. Still, for many years, Kariko’s career at the University of Pennsylvania was far from successful. She was forced to migrate from lab to lab and made dependent on one senior researcher after another to take her on board and offer her a temporary position. All that time, Kariko never earned more than USD 60,000 a year. According to The New York article quoted above, Kariko’s entire career was one huge struggle to stay afloat in the academic world. Kariko was, e.g., repeatedly denied funding as more mainstream and mundane research was always favored by academic authorities. Kariko’s own research with regard to mRNA was, by contrast, considered too unorthodox. The university did not expect her to remain on board for so lang. But Kariko persisted. And ultimately, Kariko’s efforts resulted in the two most efficient Covid-19 vaccines on the market in December 2020 (and for months afterwards). (Cf. Kolata (2021).)

    As appears from Kariko’s life story, her ultimate success had little to do with any successful research taking place in the big money-making pharmaceutical enterprises, but all to do with a life of devotion from an undervalued scientific researcher.

  9. 9.

    Allegretti and Elgot (2021).

  10. 10.

    Cf. explicitly Byttebier (2017), p. 4 (with further references).

  11. 11.

    Mazzucato (2021).

  12. 12.

    Mazzucato (2021).

  13. 13.

    Cf. Kolata (2021).

  14. 14.

    Mazzucato (2021).

  15. 15.

    Mazzucato (2021).

  16. 16.

    Cf. Foulon (2021).

    As has already been elaborated upon (cf. Sect. 2.1), since the 1970s, neoliberalism as a political-economic system started to break through in the Western world. First, neoliberalism conquered the academic world, with Nobel Prizes in economics for Friedrich Von Hayek in 1974, and then for Milton Friedman in 1976. Afterwards, as of the 1980s, neoliberalism became the dominant political doctrine, in the United Kingdom under Margaret Thatcher, and in the United States under Ronald Reagan. (Cf., furthermore, Byttebier (2015a, 2018, 2019).) Economic neoliberalism, amongst others, argues that everything goes better if people can free themselves from the suffocating grip of government. The state is portrayed as unwieldy, bureaucratic and incompetent. The private sector, on the other hand, is constantly extolled as dynamic and innovative. (Cf. Foulon (2021).)

  17. 17.

    Foulon (2021).

  18. 18.

    E.g., the same applies with regard to the capitalist money creation systems which are also based on the neoliberal “socialization of losses and privatization of profits”-principle. (See Byttebier (2017), p. 245.)

  19. 19.

    Foulon (2021).

  20. 20.

    See Balawejder et al. (2021).

  21. 21.

    Balawejder et al. (2021), p. 4, resp. p. 6.

  22. 22.

    Safi (2021).

    The researchers, hence, urged to stop perpetuating the narrative that the private sector and its search for ever more profits are the sole drivers of innovation and for recognizing that the life-saving “ChAdOx vaccine technology” had been almost completely developed with government and charitable funding. (Cf. Safi (2021).)

  23. 23.

    Mazzucato (2021).

  24. 24.

    Cf. Buranyi (2021): “As incredible as it sounds, after all the public money that went into vaccine development, making and distributing them has been left entirely up to the market. Each company has its own – totally secret – recipes and supply chains, and they insist no other approach is possible.” (Buranyi (2021).)

  25. 25.

    Aghion et al. (2020).

    According to Aghion, Maghin and Sapir, the referred to four institutions had in 2020 a combined budget of USD 55 billion (namely BARDA USD 2 billion, NIH USD 42 billion, NSF USD 8 billion and DARPA USD 3 billion). Said four institutions were said to often work separately, but sometimes together (and with others), as in the “BRAIN” (short for “Brain Research through Advancing Innovative Neurotechnologies) initiative. By way of comparison, the EU budget for funding scientific research, through Horizon 2020, also devotes considerable sums to funding innovative initiatives (around USD 13 billion in 2020), notably through the “European Research Council” (abbreviated as “ERC”) and the “European Innovation Council” (abbreviated as “EIC”), but Europe still has a long way to go before it can seriously compete with the innovation potential of the United States. (Cf. Aghion et al. (2020).)

  26. 26.

    Aghion et al. (2020).

  27. 27.

    Aghion et al. (2020).

  28. 28.

    Buranyi (2021).

  29. 29.

    Buranyi (2021).

  30. 30.

    Kollewe (2021).

  31. 31.

    Kollewe (2021).

  32. 32.

    Kollewe (2021).

  33. 33.

    Kollewe (2021).

  34. 34.

    No official reason was given for the name change, but it may have been related to the pharmaceutical crisis that involved the vaccine with cases of thrombosis, with, at the time, at least a dozen countries in Europe having suspended the use of the vaccine, but then resuming once the EMA affirmed that it was “safe and effective” against Covid-19, although—ultimately—without completely ruling out its relationship with “very rare” cases of coagulation blood associated with thrombosis. AstraZeneca itself was quick to point out that the name change of the product had not been associated with any other change in the drug, while stressing the importance that those responsible for receiving the vaccination had to be aware of the change, since the information on the product labelling and packaging could look different from before. (Cf. King (2021).)

    In order to avoid all confusion, we shall elsewhere in this book still refer to the “AstraZeneca-Vaxzevria” vaccine under its initial name “AstraZeneca” or “Oxford-AstraZeneca”.

  35. 35.

    Boseley (2021).

  36. 36.

    Kollewe (2021).

  37. 37.

    Kollewe (2021).

  38. 38.

    Kollewe (2021).

  39. 39.

    For further information on the life courses of both scientists, cf. Oltermann (2020).

  40. 40.

    Kollewe (2021).

  41. 41.

    Boseley (2021).

  42. 42.

    Boseley (2021).

  43. 43.

    Robbins and Goodman (2021).

  44. 44.

    Robbins and Goodman (2021).

  45. 45.

    Robbins and Goodman (2021).

    In comparison, Johnson & Johnson and AstraZeneca had, as noted above (cf. Sect. 9.2.3.1), both vowed to sell their vaccines on cost-basis only during the Covid-19 pandemic. Moderna, which had itself in the past never made profits and had even no other products on the market, had also decided to sell its Covid-19 vaccine for profit. This implied that, unlike Moderna’s Covid-19 vaccine, Pfizer’s sting was not crucial to the enterprise’s bottom line. With regard to 2020, Pfizer had already made USD 9.6 billion in profits, before the Covid-19 vaccine started having a noticeable impact on its results. (Cf. Robbins and Goodman (2021).)

  46. 46.

    Robbins and Goodman (2021).

  47. 47.

    Robbins and Goodman (2021).

  48. 48.

    Kollewe (2021).

  49. 49.

    Kollewe (2020).

  50. 50.

    For an overview, see https://www.modernatx.com/pipeline.

  51. 51.

    Kollewe (2020).

  52. 52.

    Kollewe (2020).

  53. 53.

    Kollewe (2021).

  54. 54.

    Kollewe (2021).

  55. 55.

    Kollewe (2021).

  56. 56.

    Kollewe (2021).

  57. 57.

    Kollewe (2021).

  58. 58.

    Kollewe (2021).

  59. 59.

    Boseley (2021).

  60. 60.

    Kollewe (2021).

  61. 61.

    Kollewe (2021).

  62. 62.

    Kollewe (2021).

  63. 63.

    Kollewe (2021).

  64. 64.

    Boseley (2021).

  65. 65.

    Kollewe (2021).

  66. 66.

    Kollewe (2021).

  67. 67.

    Kollewe (2021).

  68. 68.

    Kollewe (2021).

  69. 69.

    Kollewe (2021).

  70. 70.

    Kollewe (2021).

  71. 71.

    Boseley (2021).

  72. 72.

    The “People’s Vaccine Alliance” is a coalition of organizations and activists united by a common aim of campaigning for a “people’s vaccine” for Covid-19. This would be based on shared knowledge and freely available to everyone everywhere—a “global common good”. (Cf. The People’s Vaccine (2021). Cf. at https://peoplesvaccine.org. Accessed 15 May 2021).

  73. 73.

    Boseley (2021).

  74. 74.

    Boseley (2021).

  75. 75.

    Cf. https://www.globaljustice.org.uk. Accessed on 15 May 2021.

  76. 76.

    Boseley (2021).

  77. 77.

    Agre et al. (2021).

  78. 78.

    Balawejder et al. (2021), p. 9.

  79. 79.

    Balawejder et al. (2021), pp. 9–10.

  80. 80.

    Ball (2020).

  81. 81.

    McKeever and National Geographic Staff (2021).

  82. 82.

    Ball (2020).

  83. 83.

    Ball (2020).

  84. 84.

    Cf. Ball (2020).

    According to Ball, conventional vaccines contain either viral proteins or inactivated forms of the virus itself. These then serve to stimulate the human body’s immune defenses against infection by a live virus. In contrast, the two Covid-19 vaccines that were first reported to be effective in a series of large-scale (“Phase III”) clinical trials—more in particular the Pfizer-BioNTech vaccine and the Moderna vaccine—only used a chain of mRNA in a lipid shell. Said mRNA encodes a key protein in Covid-19. Once the mRNA has then been entered into human cells, the human body starts producing this protein. This protein then acts as an antigen, i.e., the foreign molecule that triggers an immune response to the virus. The vaccines manufactured by Pfizer and BioNTech, respectively by the US pharmaceutical enterprise Moderna, both use this technology. (Cf. Ball (2020).) Basic research on DNA vaccines had already begun at least 25 years before the outbreak of the Covid-19 pandemic, and the development of RNA vaccines highly benefited from 10 to 15 years of intense research (some of it aimed at developing cancer vaccines). In 2020, the approach has matured at just the right time—5 years earlier, RNA technology would not have been ready. (Cf. Ball (2020).)

    The third vaccine proven effective in Phase III clinical trials by November 2020 was manufactured by the pharmaceutical enterprise AstraZeneca in collaboration with Oxford University (UK). This vaccine was not based on mRNA. Instead, a viral vector (or carrier) contains additional genetic material that co-designates the peak protein of the Covid-19 virus. In a similar manner as with regard to the mRNA vaccines, the development of the Oxford-AstraZeneca vaccine also benefited from years of research for selecting the viral vector; in the case of this vaccine, the scientists had chosen a modified form of adenovirus isolated from chimpanzee stool. (Cf. Ball (2020).)

  85. 85.

    Ball (2020).

    One of the main public funders has been the US Operation Warp Speed vaccine program that had been set up by the Trump administration. This program was reported to have contributed about USD 10 billion, the largest government stimulus package pharmaceutical enterprises had ever received at the time. (Cf. Ball (2020).)

  86. 86.

    Zimmer et al. (2021) (updated 23 March 2021).

  87. 87.

    Zimmer et al. (2021) (updated 23 March 2021).

  88. 88.

    Balawejder et al. (2021), p. 11.

  89. 89.

    Zimmer et al. (2021) (updated 23 March 2021).

  90. 90.

    Balawejder et al. (2021), p. 11.

  91. 91.

    Zimmer et al. (2021) (updated 23 March 2021). Cf., furthermore, Balawejder et al. (2021), pp. 11–14.

  92. 92.

    Zimmer et al. (2021) (updated 23 March 2021).

  93. 93.

    AJMC Staff (2021). Cf., furthermore, Balawejder et al. (2021), pp. 11–14.

  94. 94.

    AJMC Staff (2021).

  95. 95.

    AJMC Staff (2021).

  96. 96.

    AJMC Staff (2021).

  97. 97.

    AJMC Staff (2021).

  98. 98.

    AJMC Staff (2021).

  99. 99.

    Zimmer et al. (2021) (updated 23 March 2021).

  100. 100.

    AJMC Staff (2021).

  101. 101.

    AJMC Staff (2021).

  102. 102.

    Zimmer et al. (2021) (updated 23 March 2021).

  103. 103.

    AJMC Staff (2021).

  104. 104.

    AJMC Staff (2021).

  105. 105.

    AJMC Staff (2021).

  106. 106.

    AJMC Staff (2021).

  107. 107.

    AJMC Staff (2021).

  108. 108.

    AJMC Staff (2021).

  109. 109.

    AJMC Staff (2021).

  110. 110.

    AJMC Staff (2021).

  111. 111.

    Zimmer et al. (2021) (updated 23 March 2021).

  112. 112.

    AJMC Staff (2021).

  113. 113.

    AJMC Staff (2021).

    With regard to the AstraZeneca trials in particular, it was indicated that an independent monitoring committee had determined that the trial of the vaccine candidate was safe to resume. These new rules, amongst others, eliminated co-payments or deductibles on vaccines for seniors on Medicare. (Cf. AJMC Staff (2021).)

  114. 114.

    It was thereby indicated that the Trump administration and the US Congress had passed legislation that provided for free Covid-19 vaccination, but new guidelines were needed to accommodate this policy objective to the various payment requirements of public and private insurance. (Cf. AJMC Staff (2021).)

  115. 115.

    AJMC Staff (2021).

  116. 116.

    AJMC Staff (2021).

  117. 117.

    AJMC Staff (2021).

  118. 118.

    These results were subsequently confirmed by various other research studies. For an overview, cf., furthermore, Olliaro (2021).

    Olliaro has also tried to explain, in laymen terms, what this 95% efficacy means. According to this author, the Pfizer and Moderna mRNA-based vaccines showed 94–95% efficacy in preventing symptomatic Covid-19, calculated as 100 × (1 minus the attack rate with the vaccine, divided by the attack rate with the placebo). This implies that in a population such as the one that participated in the testing trials, with a cumulative Covid-19 attack rate over a 3-month period of about 1% without vaccine, about 0–05% of those vaccinated were expected to still become ill. This does however not mean that 95% of vaccinated people are protected from the disease by the vaccine - a misconception about vaccine protection that, according to Olliaro, can even found in a “Lancet Infectious Diseases”-editorial. In the examples used in the latter editorial, protected people are those who would have contracted Covid-19 disease if they had not been vaccinated. Olliaro explains that this distinction is especially important because, while we know the risk reduction achieved by the Covid-19 vaccines under trial III conditions, it was still unknown if and how this might vary if the vaccines were deployed in populations with different exposures, transmission levels and attack rates. According to Olliaro, simple mathematics may help us understand this phenomenon. If we vaccinated a population of 100,000 people and protected 95% of them, this would leave 5000 people sick in 3 months, which is almost the same as the overall rate of Covid-19 cases in the United Kingdom during the month of February 2021. In contrast, a vaccine efficacy of 95% implies that instead of 1000 cases of Covid-19 to be expected in a population of 100,000 without vaccine (from the placebo arm of the above trials, about 1% would be ill with Covid-19 and 99% would not), we would only expect 50 cases in a population of 100,000 with vaccine (99–95% of the population being free of disease, at least for 3 months). (Cf. Olliaro (2021).)

  119. 119.

    AJMC Staff (2021).

  120. 120.

    AJMC Staff (2021).

    The EUA submission already included safety data with regard to 100 children aged 12–15 years. (Cf. AJMC Staff (2021).)

  121. 121.

    AJMC Staff (2021). We shall later see that these were, in part, idle promises and that it would, by contrast, be Pfizer and BioNTech that were the most efficient in producing and distributing their vaccine in sufficient doses. (Cf. Sect. 9.4.3.10.)

  122. 122.

    McKeever and National Geographic Staff (2021).

  123. 123.

    Zimmer et al. (2021) (updated 23 March 2021).

  124. 124.

    AJMC Staff (2021).

    It was reported that Pfizer and BioNTech’s application for obtaining an EUA with regard to their vaccine was heard at a one-day public meeting; by a vote of 17-4, with one abstention, the “Vaccines and Related Biological Products Advisory Committee” (abbreviated as “VRBPAC”) then reached the conclusion that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweighed the risks for people 16 years and older. (Cf. AJMC Staff (2021).)

  125. 125.

    AJMC Staff (2021).

  126. 126.

    McKeever and National Geographic Staff (2021).

  127. 127.

    McKeever and National Geographic Staff (2021).

  128. 128.

    Two months later, in order to ensure that the United States would have sufficient stock of the Covid-19 vaccines (and regardless what this implied for the rest of the world’s countries), the Biden administration would purchase another 100 million doses of the Moderna Covid-19 vaccine. (Cf. McKeever and National Geographic Staff (2021).)

  129. 129.

    AJMC Staff (2021).

    The advice, furthermore, sounded that the Moderna vaccine was to be administered 28 days apar (while the Pfizer-BioNtech’s vaccine was to be administered 21 days apart). (Cf. AJMC Staff (2021).)

  130. 130.

    AJMC Staff (2021).

  131. 131.

    AJMC Staff (2021).

  132. 132.

    AJMC Staff (2021).

  133. 133.

    AJMC Staff (2021).

  134. 134.

    AJMC Staff (2021).

  135. 135.

    Zimmer et al. (2021) (updated 23 March 2021).

  136. 136.

    Zimmer et al. (2021) (updated 23 March 2021).

  137. 137.

    Zimmer et al. (2021) (updated 23 March 2021).

  138. 138.

    McKeever and National Geographic Staff (2021).

    Previously, in December 2020, an FDA analysis with regard to the Phase III trial results of the Moderna Covid-19 vaccine had confirmed that it was 94.1% effective in preventing mild cases of Covid-19 and 100% effective in preventing severe cases, after two doses. (Cf. McKeever and National Geographic Staff (2021).)

  139. 139.

    McKeever and National Geographic Staff (2021).

  140. 140.

    McKeever and National Geographic Staff (2021).

  141. 141.

    Johnson & Johnson (2021).

    According to information provided on J&J’s own website, the J&J Covid-19 vaccine had been developed by Johnson & Johnson’s “Janssen Pharmaceutical Companies” for preventing Covid-19 in people 18 years of age and older. The decision reached by the FDA was made on the basis of the totality of scientific evidence, including data from the Phase III “TOGETHER” study that had been undertaken by J&J and from which it had appeared that the Johnson & Johnson Covid-19 vaccine was 85% effective in preventing severe disease in all regions studied and that it protected against Covid-19-related hospitalisations and deaths, starting 28 days after administration of the vaccine. The terms of the EUA granted by the FDA allowed that the vaccine would be used while further data were collected. Johnson & Johnson announced that it planned to file a “Biologics License Application” (BLA) with the FDA later in 2021. Johnson & Johnson expressed its belief that a J&J’s Covid-19 vaccine single-injection would be a critical tool in combating the global Covid-19 pandemic, especially since the trials had pointed that the vaccine granted protection in several countries, with different variants. Johnson & Johnson also reaffirmed its commitment to make its Covid-19 vaccine available on a non-profit basis for emergency pandemic use. Johnson & Johnson also announced that it had begun shipping its Covid-19 vaccine and that it expected to be able to deliver enough single-injection vaccine doses by the end of March 2020, which would allow to fully vaccinate more than 20 million people in the United States. Shortly before, Johnson & Johnson had also announced the filing of a conditional marketing authorisation application with the “European Medicines Agency” (EMA), as well as the filing of an emergency use list application with the World Health Organization for its Covid-19 vaccine candidate. (Cf. Johnson & Johnson (2021).)

  142. 142.

    McKeever and National Geographic Staff (2021).

    In the initial roll-out of the J&J Covid-19 vaccine, the company was only capable of providing a mere 4 million doses of its vaccine, with an additional 16 million doses to be provided by the end of March 2021, well short of the 37 million doses initially contracted for. The company declared that it would meet its commitment to supply 100 million doses by June 2021. On 2 March 1921, Merck announced that it would help Johnson & Johnson manufacture the vaccine. (Cf. Zimmer et al. (2021) (updated 23 March 2021).)

  143. 143.

    McKeever and National Geographic Staff (2021).

  144. 144.

    McKeever and National Geographic Staff (2021).

  145. 145.

    McKeever and National Geographic Staff (2021).

  146. 146.

    McKeever and National Geographic Staff (2021).

  147. 147.

    Guardian Staff and Agencies (2021).

  148. 148.

    Reuters (2021).

  149. 149.

    SUCH A BLA requires the submitting of non-clinical and clinical data, including the most recent analyses from the vaccine’s Phase III clinical trial. In the case of the Pfizer-BioNTech Covid-19 vaccine, this trial included more than 40,000 people and showed that “the vaccine’s efficacy and favourable safety profile were observed up to six months after the second dose”, according to a press release issued by the two enterprises. The enterprises also provided the manufacturing and facility data, as required under BLA rules. The application sought full approval only for people aged 16 and over. However, the enterprises had also announced that they were applying at the same time for an extension of the EUA with regard to adolescents aged 12–15 years. (Cf. Aratani (2021).)

  150. 150.

    Aratani (2021).

  151. 151.

    Helmore (2021).

    According to the US FDA, between March 2020 and April 2021, approximately 1.5 million Covid-19 contamination cases had been reported to the CDC in people aged 11–17 years. Pfizer was not the only enterprise that wanted to lower the age threshold for its vaccine. Moderna had also stated in the past that preliminary results from its study regarding 12- to 17-year-olds, had pointed to a strong protection and to no serious side effects. Another US company, Novavax, at the time had a Covid-19 vaccine in late-stage development and had also just started a study regarding 12–17-year-olds. Both Pfizer and Moderna had launched studies in children aged 6 months to 11 years in order to determine whether babies, pre-schoolers and school-age children would require different doses than adolescents and adults. Outside the United States, AstraZeneca has also begun studying the administration of its vaccine to 6–17-year-olds in Britain. And in China, Sinovac had announced that it had submitted preliminary data to Chinese regulatory authorities showing that its vaccine is safe for children as young as three years old. (Cf. Zimmer et al. (2021) (updated 23 March 2021).)

  152. 152.

    Zimmer et al. (2021) (updated 23 March 2021); Rybicki, et al.

    The AstraZeneca vaccine, which had been the first to reach South Africa and which had there already been administered to frontline health workers, was found to be “poorly effective” in preventing mild to moderate Covid-19 caused by the B.1.135 variant of the Covid-19 virus. Reassuringly, at the same time, there was little evidence that any of the changes identified so far in the S protein of this variant of the Covid-19 virus also affected the efficacy of the other vaccines available at the time. In fact, the efficacy of the Pfizer-BioNTech and Moderna mRNA vaccines and of the Johnson & Johnson adenovirus vaccine had been shown not to have been affected in a significant manner. This was because there were still many “epitopes”—i.e., binding sites—for antibodies in the S or RBD proteins that were not affected by the known mutations of the Covid_19 virus. According to Rybicki et al, it should be possible to remodel mRNA vaccines to counter any threat. A recent and encouraging recommendation was that Johnson & Johnson’s single injection adenovirus vaccine would be good at controlling outbreaks, while Novavax’s protein-based vaccine might offer better overall protection. (Cf. Rybicki et al. (2021).)

  153. 153.

    Zimmer et al. (2021) (updated 23 March 2021).

  154. 154.

    Zimmer et al. (2021) (updated 23 March 2021).

  155. 155.

    Zimmer et al. (2021) (updated 23 March 2021).

  156. 156.

    On 18 March 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) reaffirmed that the benefits of the Oxford-AstraZeneca Covid-19 vaccine continued to far outweigh the risks. (Cf. AstraZeneca (2021).) On the same date, the MHRA announced their review of—what they referred to as—“the small number” of thromboembolic events in over 11 million people who had received the Oxford-AstraZeneca Covid-19 vaccine in the United Kingdom. Also the UK regulator confirmed that the benefits of the Oxford-AstraZeneca Covid-19 vaccine for preventing Covid-19 far outweighed the risks, from which it was concluded that people were to continue to get vaccinated with said vaccine when asked—or told—to do so. Following a purportedly rigorous scientific review, the MHRA concluded that there was no evidence that blood clots in veins were occurring more than would be expected in the absence of vaccination. A detailed review of five UK reports of a very rare and specific type of blood clots in the cerebral veins (so-called “sinus vein thrombosis”) occurring together with lowered platelets (so-called “thrombocytopenia”) was said to be still ongoing. These side effects were, moreover, said to only have been reported in fewer than one in a million people vaccinated at the time in the United Kingdom, while a causal association with the Oxford-AstraZeneca Covid-19 vaccine was, purportedly, not established. (Cf. AstraZeneca (2021).) Subsequently, also on 18 March 2021, the EMA’s “Pharmacovigilance Risk Assessment Committee” (PRAC) came to the conclusion that there was no increase in the overall risk of blood clots (i.e., thromboembolic events) with regard to the Oxford-AstraZeneca Covid-19 vaccine. However, the PRAC also pointed out that, with regard to very rare cases of serious thromboembolic events with thrombocytopenia, although a causal link with the Oxford-AstraZeneca Covid-19 vaccine was not proven, it remained possible and deserved further analysis. Furthermore, there was no evidence of a problem related to specific batches of the Oxford-AstraZeneca Covid-19 vaccine, or to particular manufacturing sites. (Cf. AstraZeneca (2021).) AstraZeneca itself announced that it would continue to work closely with health authorities to ensure the appropriate use of the Oxford-AstraZeneca Covid-19 vaccine. The enterprise recognized and promised to implement all recommendations of the PRAC, including the providing of a more detailed update of the product information, whilst continuing to understand the nature and relevance of these events to ensure the safe delivery of the vaccine would continue during the Covid-19 public health crisis. AstraZeneca also announced that an analysis of its safety database on tens of millions of records with regard to the Oxford-AstraZeneca Covid-19 vaccine did not show that these events occurred any more commonly than would be expected among millions of people. (Cf. AstraZeneca (2021).)

  157. 157.

    Denmark became the first country in Europe to suspend the use of the Oxford-AstraZeneca Covid-19 vaccine as part of its immunisation programme, after rare but serious cases of blood clots had been reported among people who had been administered the vaccine. More in particular, in Denmark, two cases of thrombosis, one of which had been fatal, were linked to vaccinations with the Oxford-AstraZeneca Covid-19 vaccine, after more than 140,000 people had received the jab. More than a dozen countries first followed the example of Denmark, but all but a few resumed the use of the Oxford-AstraZeneca Covid-19 vaccine soon after, more precisely, after the EMA had stressed that the benefits of the Oxford-AstraZeneca Covid-19 vaccine by far outweighed the risks and that the vaccine was sufficiently “safe and effective”. Although by 4 April 2021, the EMA had received reports of 169 cases of cerebral venous sinus thrombosis (CVST), it did not consider this to be sufficient cause for further alarm. As we have said, the real reason for the EMA’s tough stance was, most likely, that the EU authorities were at the time relying heavily on the cheap Oxford-AstraZeneca Covid-19 vaccine as the main weapon in their fight against the Covid-19 pandemic. (Cf. Beaumont (2021); Busvine (2021).)

    On 14 April 2021, Denmark announced that it would no longer use the Oxford-AstraZeneca Covid-19 vaccine at all in its immunisation programme, becoming the first country to discontinue the use of the vaccine completely. Denmark made this decision despite strong recommendations from the WHO and the EMA to continue using this inoculation, as they kept believing that the benefits of the vaccine far outweigh its potential risks. (Cf. Beaumont (2021).)

  158. 158.

    Greinacher et al. (2021).

  159. 159.

    Greinacher et al. (2021).

  160. 160.

    Henley and Sample (2021).

  161. 161.

    Henley and Sample (2021).

  162. 162.

    Berkeley and Kopecki (2021).

    As explained earlier, such an EUA grants a conditional approval based on two months of safety data, pending a further application for full approval, the latter typically requiring at least 6 months of data. J&J had for the first time submitted its Covid-19 vaccine data to the FDA in February 2021, and no specific concerns had been identified at the time after analysis by age, race and comorbidities, according to the agency. The FDA had at the time said that the most commonly reported side effects of the J&J Covid-19 vaccine were headache and fatigue, followed by muscle pain, nausea and fever. (Cf. Berkeley and Kopecki (2021).)

  163. 163.

    Berkeley and Kopecki (2021). Cf., furthermore, Beaumont (2021).

    On the FDA-website, it was announced that the FDA and CDC had begun reviewing data on six cases reported to the Vaccine Adverse Event Reporting System (abbreviated as “VAERS”) of low platelet levels in the blood, associated with a rare and serious type of blood clot called “cerebral venous sinus thrombosis” (or “CVST”) in people who had received the Johnson & Johnson Covid-19 vaccine. The FDA website, moreover, reported that one of the concerned persons had died, and that all cases had occurred in women between the ages of 18 and 48. In some of the reported cases of CVST, the blood clots had also involved large veins in the abdomen. The FDA, furthermore, said that “out of an abundance of caution”, the FDA and CDC had recommended a pause in the use of the Johnson & Johnson Covid-19 vaccine, while the FDA and CDC, through their Advisory Committee on Immunisation Practices, would further investigate the reports with regard to the serious adverse events. The FDA thereby emphasised that it concerned an important matter, in part, as it had to be ensured that healthcare professionals would be well aware of the potential for these adverse events and would be able to plan for appropriate recognition and management due to the unique treatment required for CVST with low platelet levels. The FDA, hence, concluded that the safety monitoring programme put in place for monitoring the Covid-19 vaccines had been working, as it had been able to detect reports of these very rare and serious adverse events at an early stage and to take steps to evaluate them. The FDA also announced that the FDA and CDC would continue to thoroughly investigate all reports to determine if there was a causal relationship. (Cf. US Food & Drug Administration (2021) (as accessed on 14 April 2021).)

  164. 164.

    Berkeley and Kopecki (2021).

  165. 165.

    Berkeley and Kopecki (2021).

    At the time, of the in total 120 million people to whom a Covid-19 vaccine had been administered in the United States, about 6.9 million had received the Johnson & Johnson Covid-19 vaccine. Dr Fauci, in his capacity of the White House’s chief medical advisor, declared during a separate press conference that there had been no similar red flags with regard to the Pfizer-BioNTech and Moderna Covid-19 vaccines. Dr Fauci also explained that the pause with regard to the Johnson & Johnson Covid-19 vaccine was expected to last between a few days and a few weeks, which would give the FDA and CDC the necessary time to further investigate the six reported cases and to try and figure out what had been going on, and more in particular what the six women had had in common. (Cf. Berkeley and Kopecki (2021).)

  166. 166.

    Berkeley and Kopecki (2021).

  167. 167.

    Henley and Sample (2021).

    In its statement, the EMA said that it had investigated eight serious cases of unusual blood clots associated with low blood platelet levels, including one death, in the United States, where, at the time, more than 7 million people had been administered the Johnson & Johnson Covid-19 vaccine by then. According to the EMA, all cases had occurred in people under 60 years of age, mainly women, within 3 weeks upon receiving the vaccination. As had been the case with regard to the Oxford-AstraZeneca Covid-19 vaccine, in most cases, the blood clots had occurred in the brain and abdomen. The EMA indicated that these events should be listed as “very rare side effects” of the vaccine. At its meeting on 20 April 2021, the PRAC, the EMA’s safety committee, concluded that a warning about unusual blood clots with low blood platelet counts had to be added to the product information for the Johnson & Johnson Covid-19 vaccine. The PRAC also concluded that these events could be listed as “very rare vaccine side effects”. (Cf. EMA (2021).)

  168. 168.

    Henley and Sample (2021).

  169. 169.

    Beaumont (2021).

  170. 170.

    Busvine (2021).

  171. 171.

    Henley and Sample (2021).

  172. 172.

    Henley and Sample (2021).

    At that time, German and Norwegian scientists had indicated that some people to whom the Oxford-AstraZeneca Covid-19 vaccine had been administered, were experiencing an abnormal reaction of their immune system, leading some of these experts to suspect that a similar mechanism might be occurring with regard to the reaction to the Johnson & Johnson Covid-19 vaccine. This suspicion was further supported by the fact that both Covid-19 vaccines made use of the same technology, which causes the human body’s immune system to recognize the spike protein that coats the Covid-19 virus by using a cold virus—called adenovirus—to carry the spike gene into the human body. (Cf. Henley and Sample (2021).) However, the issue was still under further investigation.

  173. 173.

    Henley and Sample (2021).

  174. 174.

    Henley and Sample (2021).

  175. 175.

    Henley and Sample (2021).

  176. 176.

    Cf. del Mar Murphy-Marcos (2021).

    The report, e.g., stated that the paint on the walls of the factory was peeling in several places and that paint stains had been found on the floor (from which it could be assumed that it had also been dripping in the vaccine baches themselves). (For the text of the report, cf. https://www.fda.gov/media/147762/download). The report also found brown residues on the walls and floors. By the end of March 2021, the drug manufacturer itself had reported that it had discovered a problem with an ingredient used in the Johnson & Johnson Covid-19 vaccine at the said Baltimore production site, and had stopped manufacturing there. The factory was, as indicated, owned by “Emergent Biosolutions”, one of the more than 10 companies that Johnson & Johnson used to speed up manufacturing. FDA officials declared having reviewed security camera footage from the factory in order to prepare their report. The footage from 27 January 2021 until 3 February 2021, showed that laborers had failed to follow procedures to prevent cross-contamination in several instances. Product components, containers and closures had not been stored in a manner that could have prevented contamination, according to the FDA report. “We will not allow the release of any product until we feel confident that it meets our expectations for quality,” read a statement from the FDA. “The firm has failed to adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense, and engineering operations to prevent cross contamination,” the report added. The report, furthermore, indicated that the equipment used in the plant had not been of adequate size to enable operations for its intended use or for cleaning. “Johnson & Johnson will exercise its oversight authority to ensure that all of FDA’s observations are addressed promptly and comprehensively,” sounded a responsive statement by Johnson & Johnson itself. “The company promised to redouble its efforts as it continued to work toward securing emergency use authorization in the USA for drug substance manufactured at Emergent Bayview as quickly as possible, so that the company could help bring an end to this global pandemic.” (Cf. del Mar Murphy-Marcos (2021).)

  177. 177.

    Cf. Danish Health Authority (2021).

    The decision had been reached after the Danish health authority had come to the conclusion that the benefits of using the Johnson & Johnson Covid-19 vaccine did not outweigh the risk of causing the possible side effects in people to whom the vaccine would be administered. Because of this conclusion, the Danish health authorities announced that they would continue the Danish Covid-19 vaccination programme without resorting to the Johnson & Johnson Covid-19 vaccine. (Cf. Danish Health Authority (2021).)

  178. 178.

    The Danish health authority declared that it would continue to review the ongoing release of data from, e.g., the US Health and Drug Administration, which, due to the situation of the Covid-19 epidemic in the United States, had itself ultimately chosen to include the Johnson & Johnson’s Covid-19 vaccine in its vaccination campaign. The Danish Health Authority stated that it needed more information and safety data with regard to the vaccine in order to determine whether women were at greater risk of unusual but serious blood clotting events than men, or vice versa. (Cf. Danish Health Authority (2021).)

  179. 179.

    France24, AFP and Reuters (2021). Cf., furthermore, Danish Health Authority (2021).

  180. 180.

    Oltermann (2021).

  181. 181.

    Beaumont (2021).

  182. 182.

    Beaumont (2021).

  183. 183.

    Beaumont (2021).

  184. 184.

    Henley and Sample (2021).

  185. 185.

    European Centre for Disease Prevention and Control (2021b), p. 14.

  186. 186.

    European Centre for Disease Prevention and Control (2021b), p. 15.

    E.g., from an evaluation of real-world immune responses after vaccination with the Comirnaty mRNA vaccine developed by BioNTech-Pfizer in the United Kingdom, in which the recommended two-dose schedule had been respected by leaving an interval of three months among a small sample of 23 participants, it had appeared that a proportion of the vaccinated people over 80 years of age had had a sub-optimal neutralising antibody response three weeks after vaccination, while the subsequent second dose of the vaccine was associated with robust neutralising responses. The conclusion of this trial was that a significant proportion of people over 80 years of age appeared to require a second dose of the Pfizer-BioNTech Covid-19 vaccine at three weeks in order to achieve a sufficient degree of Covid-19 virus neutralisation. From an Israeli study, it had appeared that the efficacy of BioNTech-Pfizer’s Comirnaty vaccine in an Israeli cohort consisting of participants aged 16 years and older with a median age of 59.7 years, increased progressively from day 14 onwards after a first jab, in order to reach a peak efficacy of about 90% immunity on day 21 before a second dose was given. However, it was not known how long this immunity after the first jab of the vaccine could last beyond said time frame of 21 days without the administration of a second dose. From the new evidence, it also appeared that the Oxford-AstraZeneca Covid-19 vaccine provided a good neutralising antibody response after one dose already. (Cf. European Centre for Disease Prevention and Control (2021b), p. 15.)

  187. 187.

    Cf., furthermore, European Centre for Disease Prevention and Control (2021b), p. 15.

  188. 188.

    European Centre for Disease Prevention and Control (2021b), p. 15.

  189. 189.

    European Centre for Disease Prevention and Control (2021b), p. 15.

    Such a trial was thus launched in the United Kingdom, in which a first jab with the Oxford-AstraZeneca Covid-19 vaccine was to be followed by a second jab with the BioNTech-Pfizer Covid-19 vaccine, and vice versa, with either four- or 12-week interval schedules. It was also considered to start similar trials based on other vaccines, such as the Johnson & Johnson vaccine and the Novavax vaccine. AstraZeneca similarly announced that there would be a mixed-dose trial between the Oxford-AstraZeneca Covid-19 vaccine and the Sputnik V Covid-19 vaccine, to be conducted in Azerbaijan. (Cf. European Centre for Disease Prevention and Control (2021b), p. 15.)

  190. 190.

    Guardian Staff and Agencies (2021).

  191. 191.

    Guardian Staff and Agencies (2021).

  192. 192.

    Cf. Europees Instituut voor Bio-ethiek (2020).

  193. 193.

    Otherwise put, the Pfizer-BioNTech and Moderna Covid-19 vaccines had (only) been tested on cells lines produced from cells that originally came from an aborted fetus. These vaccines, however, were not developed or used of abortion-derived cell lines in the manufacturing and/or development process (contrary to what was the case for the Oxford-AstraZeneca and Johnson & Johnson Covid-19 vaccines).

  194. 194.

    Saint John Paul II (1995).

  195. 195.

    Cf. Pontificia Academia Pro Vita (2005).

  196. 196.

    Next to the term “evil”, also the term “sinful act” is used in the letter to describe the practices involved in developing, producing and/or using such vaccines.

  197. 197.

    Congregation for the Doctrine of the Fate (2008).

    The statement “Dignitas personae” itself refers to the statement “Donum vitae”, which calls in a general sense for the respect of human embryos (and also mentions a prohibition of their commercial use). However, this statement does not mention anything specific regarding vaccines based on cell material of aborted fetuses themselves. (Cf. Congregation for the Doctrine of the Fate (2007).)

  198. 198.

    Brown and Ingold (2020).

  199. 199.

    Archdiocese of Denver (2020).

  200. 200.

    Oficina de prensa de la Santa Sede (2020).

  201. 201.

    Vatican News (2020).

  202. 202.

    Wooden (2020).

  203. 203.

    https://www.catholicweekly.com.au/archbishop-fisher-op-lets-not-create-an-ethical-dilemma/.

  204. 204.

    For an interesting overview, cf. Carfleo (2020).

  205. 205.

    AP (2021); Ali (2021).

    Bishop Wróbel had noted that unlike the vaccines against Covid-19, which use mRNA-based technology and do not raise significant moral objections, cell lines created from biological material taken from aborted fetuses are used in the production of the Covid-19 vaccines of Oxford-AstraZeneca and Johnson & Johnson,” which raises serious moral objections implying that Catholics should not receive these vaccines. According to the bishop, such vaccines could only be used “without moral guilt” only if people have no other choice and are directly required to be inoculated under certain conditions, such as for work, as in this case, use of the vaccine does would imply direct participation in, acceptance of, or coercion to have abortion. (Cf. Ali (2021).)

  206. 206.

    Fadel, et al. (2020).

  207. 207.

    Harvard Medical School (2021) (updated on 4 March 2021).

    With regard to acetaminophen, the total daily dose of all products taken should not exceed 3,000 milligrams. (Cf. Harvard Medical School (2021) (updated on 4 March 2021).)

  208. 208.

    Harvard Medical School (2021) (updated on 4 March 2021).

  209. 209.

    Harvard Medical School (2021) (updated on 4 March 2021).

    For people who suspect or know that they have contracted Covid-19 and cannot take acetaminophen, or who have taken the maximum dose and remain in need of relieving their symptoms, there is no need to specifically avoid taking over the counter ibuprofen. (Cf. Harvard Medical School (2021) (updated on 4 March 2021).)

  210. 210.

    AJMC Staff (2021).

  211. 211.

    AJMC Staff (2021).

    The results of the trial data on which the decision of the FDA was based, indicated that Covid-19 patients who had been given the treatment had a 31% faster recovery time than patients who had only been given a placebo (P < 0.001). This corresponded with an overall recovery time of 11 days in the Remdesivir intervention cohort, compared with 15 days in the control group. The trial data also suggested a survival advantage, with a mortality rate of 8.0% for the group of patients who had been given Remdesivir, versus 11.6% for the group who had been given the placebo (P = 0.059). Findings by an independent data and safety monitoring board (DSMB) concurred with these trial data. However, at the time, the research had not yet been subjected to peer-review. A separate multi-centre placebo-controlled study, published on 29 April 2020, later indicated that Remdesivir offered no benefit to patients with Covid-19. (Cf. Melilo (2020).)

  212. 212.

    Harvard Medical School (2021) (updated on 4 March 2021). Cf., furthermore, AJMC Staff (2021).

  213. 213.

    European Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021).

    The study pointed to a relative risk of death = 0.95, 95% CI 0.81–1.11, p = 0.50. The authors of this research reached the conclusion that resorting to Remdesivir did not have an effect on time of discharge among Covid-19 patients, although the study was not designed to answer this question. The results of a double-blind RCT, ACTT-1, in 1062 hospitalised patients with Covid-19, in contrast, pointed out that Remdesivir was associated with a shorter median recovery time than a placebo (10 versus 15 days). According to this research, mortality at 14 days was 6.7% in the Remdesivir group and 11.9% in the placebo group, but the difference was considered of being not statistically significant. Another randomised controlled trial involving 584 patients with moderate Covid-19 disease in 105 hospitals in Europe, the United States and Asia found a slight improvement in clinical status in the 5-day group, but no difference between the 10-day group and standard care. The authors of this study concluded that this result was of uncertain clinical significance. (Cf. European Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021).)

  214. 214.

    European Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021).

  215. 215.

    AJMC Staff (2021). Cf., furthermore, Inserro (2020).

  216. 216.

    AJMC Staff (2021). Cf., furthermore, Inserro (2020).

  217. 217.

    Inserro (2020).

  218. 218.

    Inserro (2020).

  219. 219.

    AJMC Staff (2021).

  220. 220.

    AJMC Staff (2021).

  221. 221.

    Harvard Medical School (2021) (updated on 4 March 2021).

  222. 222.

    Harvard Medical School (2021) (updated on 4 March 2021).

  223. 223.

    European Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021).

  224. 224.

    Roberts (2021).

  225. 225.

    European Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021).

  226. 226.

    Gallagher (2021).

  227. 227.

    Roberts (2021).

    Professor Martin Landray, at the time co-principal investigator of the RECOVERY trial and medical expert at the University of Oxford, had declared: “Used in combination, the impact is substantial. This is good news for patients and good news for the health services that care for them in the UK and around the world.” Dr Charlotte Summers, an intensive care medic at Addenbrooke’s Hospital in Cambridge, said: “These findings are a tremendous step forwards. This therapy looks like it keeps people out of the intensive care unit so they never need to see people like me which can only be a good thing.” (Cf. Roberts (2021).)

  228. 228.

    Roberts (2021).

  229. 229.

    Harvard Medical School (2021) (updated on 4 March 2021).

    The NIH recommendation was based on the results of the already above-quoted RECOVERY trial. In this study, more than 6000 patients hospitalised with Covid-19 were randomly assigned to receive either dexamethasone or standard therapy. It had appeared that patients who required supplemental oxygen or ventilators and received dexamethasone were less likely to die within 28 days than those who received standard treatment. Dexamethasone, however, did not have a beneficial effect in patients who did not require respiratory support. (Cf. Harvard Medical School (2021) (updated on 4 March 2021; European Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021). Cf., furthermore, The RECOVERY Collaborative Group (2021).)

  230. 230.

    Harvard Medical School (2021) (as updated on 4 March 2021). Cf., furthermore, European Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021).

    All of the three referred to monoclonal antibody treatments have been tested in separate clinical trials. From these, it appeared that Bamlanivimab alone and the combination of casirivimab and imdevimab significantly reduced the risk of being hospitalised because of Covid-19, or of having to pay a visit to the emergency room, within 28 days of starting treatment, compared to placebo. It similarly appeared that the combination of bamlanivimab and etesevimab significantly reduced the risk of hospitalization or death within 29 days of treatment compared to placebo. (Harvard Medical School (2021) (as updated on 4 March 2021). Cf., furthermore, European Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021).)

  231. 231.

    Harvard Medical School (2021) (as updated on 4 March 2021). Cf., furthermore, European Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021).

    All of the three referred to monoclonal antibody treatments have been tested in separate clinical trials. From these, it appeared that Bamlanivimab alone and the combination of casirivimab and imdevimab significantly reduced the risk of being hospitalised because of Covid-19, or of having to pay a visit to the emergency room, within 28 days of starting treatment, compared to placebo. It similarly appeared that the combination of bamlanivimab and etesevimab significantly reduced the risk of hospitalization or death within 29 days of treatment compared to placebo. (Harvard Medical School (2021) (as updated on 4 March 2021). Cf., furthermore, European Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021).)

  232. 232.

    Harvard Medical School (2021) (as updated on 4 March 2021). Cf., furthermore, Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021).

  233. 233.

    AJMC Staff (2021).

  234. 234.

    REGN-COV2 is a mixture of two monoclonal antibodies (namely REGN10933 and REGN 10987). (Cf. AJMC Staff (2021).)

  235. 235.

    AJMC Staff (2021).

  236. 236.

    AJMC Staff (2021).

  237. 237.

    AJMC Staff (2021).

    Bamlanivimab is a monoclonal antibody treatment that mimics the immune system’s response to Covid-19 infection. It had appeared that bamlanivimab offers protection to high-risk Covid-19 patients from progressing to more severe forms of the Covid-19 disease. Clinical trials had, more in particular, shown a reduction in Covid-19–related hospitalizations or emergency room visits in these patients within 28 days of treatment, compared with patients that had been given placebo. (AJMC Staff (2021).)

  238. 238.

    AJMC Staff (2021).

  239. 239.

    Boffey (2021c).

  240. 240.

    Harvard Medical School (2021) (updated on 4 March 2021).

  241. 241.

    Harvard Medical School (2021) (updated on 4 March 2021). Cf., furthermore, AJMC Staff (2021).

  242. 242.

    Cf. Harvard Medical School (2021) (updated on 4 March 2021). Cf., furthermore, AJMC Staff (2021).

  243. 243.

    Harvard Medical School (2021) (updated on 4 March 2021). Cf., furthermore, AJMC Staff (2021).

  244. 244.

    Harvard Medical School (2021) (updated on 4 March 2021). Cf., furthermore, AJMC Staff (2021).

    A small but well-designed (based on randomised, double-blind and placebo-controlled trials) study was published in the New England Journal of Medicine in January 2021. This study had only included patients aged 65 and over. The researchers had screened the convalescent plasma in order to ensure that it contained sufficiently high levels of antibodies. The researchers had found that patients who had received convalescent plasma within three days of symptom onset had been 48% less likely to develop severe Covid-19 disease, compared to patients who had only been given a placebo. However, a meta-analysis of four peer-reviewed, randomised clinical trials that was later published in JAMA showed less promising results. The trials included in the latter analysis comprised 1,060 patients with Covid-19 who had received either convalescent plasma, placebo or standard therapy. Compared to the patients been given placebo or standard therapy, it appeared that convalescent plasma did not significantly improve the risk of death, duration of the length of hospital stay or the need for a ventilator. The study authors, however, noted that the number of cases used for this analysis had been small, and that future clinical trials might still suggest that convalescent plasma therapy is more beneficial. (Cf. Harvard Medical School (2021) (updated on 4 March 2021). Cf., furthermore, AJMC Staff (2021).)

  245. 245.

    AJMC Staff (2021).

  246. 246.

    European Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021).

  247. 247.

    AJMC Staff (2021).

  248. 248.

    BBC News (2020a).

  249. 249.

    BBC News (2020a).

  250. 250.

    Gallagher (2021); BBC News (2020a).

    When this book went to press, research was still ongoing to find out if other steroids could be useful in the treatment of Covid-19. One of these studies highlighted that early use of a short course of methylprednisolone in patients with moderate to severe Covid-19 could prevent disease progression and improve outcomes, while noting that further research was needed to better define the role of corticosteroids in Covid-19 patients at high risk of clinical deterioration, identified early in the course of the disease by using prognostic markers or clinical prediction tools. (Cf. Fadel et al. (2020).)

  251. 251.

    BBC News (2020a).

    According to the scientists who conducted the trials contained in said research, one in three deaths could thus have been prevented in patients on ventilators. There was no significant benefit for patients not receiving ventilators. (Cf. BBC News (2020a).)

  252. 252.

    BBC News (2020a).

  253. 253.

    BBC News (2020a).

  254. 254.

    The new treatment was developed at Southampton University Hospital and is produced by the Southampton-based biotechnology company “Synairgen”. One treatment with the new drug could cost around £2000. (Cf. Rowlatt (2021).)

  255. 255.

    Beta interferon is explained to be part of the body’s first line of defence against viruses, warning it of a possible viral attack. However, the Covid-19 virus appears to suppress the production of beta interferon as part of its strategy to evade the human immune system. The new drug itself is a special form of interferon beta to be delivered directly into the airways by a nebuliser that turns the protein into an aerosol. The further idea is that a direct dose of the protein into the lungs would trigger a strong antiviral response, even in patients whose immune systems are already weak. Beta interferon has already before been commonly used in the treatment of multiple sclerosis. Previous clinical trials conducted by Synairgen have shown that it can stimulate an immune response and that patients with asthma and other chronic lung diseases can tolerate the treatment without problems. (Cf. Rowlatt (2021).)

  256. 256.

    Rowlatt (2021).

  257. 257.

    Rowlatt (2021).

  258. 258.

    Rowlatt (2021).

  259. 259.

    Harvard Medical School (2021) (updated on 4 March 2021).

  260. 260.

    Data from experimental in vitro studies had initially indicated that hydroxychloroquine and chloroquine had an inhibitory effect on SARS-CoV-2. However, later RCTs, such as the already above-quoted WHO SOLIDARITY trial and RECOVERY, had found no evidence of a significant benefit of hydroxychloroquine for the treatment of Covid-19 patients, as a result of which said RCTs had dropped the hydroxychloroquine arm of their trials. The RECOVERY RCT had, e.g., compared 1542 patients randomised to receive hydroxychloroquine, with 3132 patients who had only been given usual care. RECOVERY had found no difference between the two groups in terms of mortality, hospital stay duration or other clinical outcomes. Two other clinical trials that had studied the effect of hydroxychloroquine when starting such a treatment early (within 4–5 days of Covid-19 symptom onset) in outpatients with mild symptoms, had in a similar manner showed no significant effect on symptom severity. A further randomised controlled RCT of post-exposure prophylaxis involving 821 people who had been detained, or exposed, to confirmed cases of Covid-19 showed no statistically significant difference in the subsequent incidence of Covid-19 disease among the hydroxychloroquine group versus the placebo group. (Cf. European Centre for Disease Prevention and Control (2021a) (as accessed on 25 March 2021). Cf., furthermore, AJMC Staff (2021).)

    On 4 June 2020, the New England Journal of Medicine and The Lancet both retracted two studies on the use of hydroxychloroquine in Covid-19, after the authors had declared that they could not vouch for the data they had been referring to in said studies. More in particular, information that was derived from a private database of medical records compiled by a little-known company called “Surgisphere” had been used in both studies. The retractions highlighted the difficulty of disclosing research with regard to Covid-19, while being able to ensure the accuracy of the data resorted to. (Cf. AJMC Staff (2021).)

    Just days after the WHO had halted its own trial, on 20 June 2020, the NIH announced that it was testing the safety and efficacy of hydroxychloroquine as a treatment for Covid-19. The study indicated that the treatment was not harmful, but that it did not provide any benefit either. (Cf. AJMC Staff (2021).)

    By March 2021, only the UK COPCOV RCT, aimed at recruiting 40,000 healthcare laborers and other at-risk personnel worldwide, was still investigating the efficacy of hydroxychloroquine as a prophylaxis. (Cf. AJMC Staff (2021).)

  261. 261.

    Harvard Medical School (2021) (updated on 4 March 2021).

  262. 262.

    Solender (2020).

  263. 263.

    It indeed appeared that Trump had a “small personal financial interest” in Sanofi, the French drugmaker that produces a branded version of the hydroxychloroquine drug. Sanofi, more in particular, was the producer of “Plaquenil”, a branded form of hydroxychloroquine. It had, more in particular, appeared that the three Trump family trusts had been investing in a Dodge & Cox mutual fund, in which Sanofi was the largest holding. Forbes estimated that the financial value of Trump’s stake in Sanofi amounted to less than USD 3000. However, it furthermore appeared that billionaire Ken Fisher, one of the major donors of the Republican party (including of Trump himself), was a major shareholder in Sanofi at the time, while US Commerce Secretary Wilbur Ross was conducting a fund that also invested in Sanofi. (Cf. Voytko (2020).)

    In a statement of 6 April 2020, Fisher explained that Sanofi was neither a major holding of Fisher Investments, nor of Ken Fisher personally. (Cf. Fisher Investments (2020).) The statement added to this declaration that: “The company represents less than 0.8% of Fisher Investments’ portfolio, and the company’s stake is less than 0.7% of Sanofi. Neither the company nor Ken Fisher has ever promoted the drug described in the New York Times article in any way or discussed it with anyone.” (Fisher Investments (2020).)

  264. 264.

    Kravitz (2020).

    Between 17 February 2020 and 27 April 2020, US physicians were reported to have written 483,000 more prescriptions for the malaria drug hydroxychloroquine than in the same period in 2019. It thereby appeared that in the week after President Donald Trump had first mentioned the efficacy of the drug for preventing and treating Covid-19 at a press conference, medical prescriptions had increased by more than 200% compared to the previous year. The vast majority of these excess medical prescriptions had been written between 14 March 2020 and 4 April 2020, but when news started spreading about shortages of the drug and about the lack of evidence for supporting the claim that it could be used for treating Covid-19, medical prescriptions quickly returned to normal. However, by the time it ultimately became clear that the once-promising malaria drug was probably useless for preventing or treating Covid19, a lot of damage had already been done. It was more in particular estimated that hundreds of thousands of Americans had been unnecessarily taking the drug that could have dangerous side effects. In addition, many people with a real medical need for hydroxychloroquine—such as those suffering from lupus or related autoimmune diseases—had found themselves temporarily unable to acquire the drugs they needed. It was believed that the unprecedented combination of dubious science, vocal public advocating by the US President himself, and patient influence over physicians, probably resulted in nearly half a million medical prescriptions before the public health benefits and risks were finally properly understood. (Cf. Kravitz (2020).)

  265. 265.

    Cf. Harvard Medical School (2021) (updated on 4 March 2021), where it is also pointed out that physicians should always consider the risk of severe bleeding when prescribing full doses.

  266. 266.

    Harvard Medical School (2021) (updated on 4 March 2021).

    In normal circumstances, the human body itself makes vitamin D when exposed to the sun. It is hereby assumed that five to ten minutes of direct sun exposure on the arms, legs or back, during some or most days of the week and without using sunscreen, may allow a human being to make enough vitamin D. In addition, good dietary sources of vitamin D are oily fish (such as tuna, mackerel and salmon), foods fortified with vitamin D (such as dairy products, soya milk and cereals), cheese and egg yolk. According to the Harvard Medical School, the recommended dietary allowance of vitamin D consists of 600 IU per day for adults up to 70 years of age, and 800 IU per day for adults over 70 years of age. A daily supplement containing 1000–2000 IU of vitamin D is suspected to be probably safe for most people. For adults, the risk of harm is said to increase above 4000 IU per day. (Cf. Harvard Medical School (2021) (updated on 4 March 2021).)

  267. 267.

    Cf. Harvard Medical School (2021) (updated on 4 March 2021), furthermore, pointing to the fact that, while standard doses of vitamin C may generally be considered harmless, high doses can lead to a number of side effects, including nausea, cramps and an increased risk of kidney stones.

  268. 268.

    A viral test may be resorted to in order to find out if a person suffers from an ongoing Covid-19 infection. There are two main types of such viral tests: nucleic acid amplification tests (NAATs) and antigen tests. (Cf. CDC (2021a) (as updated on 17 March 2021).)

  269. 269.

    Duncan (2020).

  270. 270.

    CDC (2021a) (as updated on 17 March 2021).

  271. 271.

    Duncan (2020).

  272. 272.

    Duncan (2020).

  273. 273.

    Duncan (2020).

  274. 274.

    Duncan (2020).

  275. 275.

    Duncan (2020).

    One(small) study with regard to these at-home testing kits has indicated that when people learn the correct technique for collecting their own mucus or saliva sample, self-testing may provide with results that can be just as accurate as those performed by health care workers. (Cf. Duncan (2020).)

  276. 276.

    AJMC Staff (2021).

  277. 277.

    AJMC Staff (2020).

  278. 278.

    AJMC Staff (2021).

  279. 279.

    AJMC Staff (2021).

  280. 280.

    Duncan (2020).

    Duncan has, furthermore, pointed out that while RNA tests are very sensitive and can, e.g., still provide a positive testing result when a person is no longer actually ill and is no longer excreting viruses that can infect others, antigenic tests are faster and cheaper, but in many cases less accurate than RNA tests. Antigenic tests are also more likely to give false-negative results, which implies that they are more likely to miss cases of active Covid-19 infection. Neither antigenic nor RNA tests can predict when a person is no longer infectious. (Cf. Duncan (2020).)

  281. 281.

    Duncan (2020).

  282. 282.

    Duncan (2020).

  283. 283.

    Antibodies can be defined as proteins that the immune system of the body produces to fight a foreign invader, such as a virus. (Cf. Duncan (2020).)

  284. 284.

    Duncan (2020). Cf., furthermore, Harvard Medical School (2021) (updated on 4 March 2021).

  285. 285.

    Duncan (2020).

  286. 286.

    Harvard Medical School (2021) (updated on 4 March 2021).

  287. 287.

    Duncan (2020).

  288. 288.

    Not that this argument was made before the breakthrough of the Indian—later referred to as “delta”—variant of the Covid-19 virus, which would lead to the questioning of the idea that the Covid-19 vaccinations would result in group or herd immunity.

  289. 289.

    Maçães (2021).

  290. 290.

    Elflein (2021).

  291. 291.

    Kluger (2021).

    These findings stem from a probability-based online Gallup Panel survey conducted between 16 and 29 November 2020, which started a week after the announcement by Pfizer and BioNTech that their Covid-19 vaccine had proved better than 90% effective in Phase III clinical trials. Shortly after, Moderna had made a similar announcement (cf. Sect. 9.3.1.3). (Cf. Brenan (2020).)

    Gallup had for the first time asked Americans in July 2020 about their likelihood of being vaccinated on a voluntary basis, and at least three in five had then said they would do so. That proportion persisted throughout August 2020. However, in mid-to late September 2020, the public’s readiness to be vaccinated suddenly dropped. This sharp decline followed an announcement by AstraZeneca that its vaccine trials were halted because of adverse participant reactions. Additionally, it is believed that statements by, on one side, President Donald Trump and, on the other side, Democratic vice-presidential nominee Kamala Harris may have affected Americans’ views as well. Trump had declared in early September 2020 that a Covid-19 vaccine could already be available before Election Day, an announcement that started raising questions about pressure being put on the FDA to expedite approval. For her part, Harris had declared that she would not get a Covid-19 vaccine on Trump’s advice alone, while, furthermore, expressing her concern about the potential for political interference in the Covid-19 vaccine approval process. By the end of October, started to rebound again, rising to 58%. (Cf. Brenan (2020).)

  292. 292.

    Kluger (2021).

  293. 293.

    Kluger (2021).

  294. 294.

    Kluger (2021). Cf., furthermore, Kluger (2020).

    Bill Gates rejected this conspiracy theory in a letter of 22 December 2020 which he posted on his website. For the text of the letter of Bill Gates, cf. Gates (2020).

    In the said letter, Gates wrote: “It doesn’t help that there are false conspiracy theories about vaccines, including some that involve Melinda and me. For our part, we will keep talking about the sole reason we fund vaccines: because we’re passionate about saving lives and making sure all children have a chance to grow into adulthood. We feel a responsibility to give our wealth back to society, and we believe that no outlet for our giving returns more value to the world than helping develop and distribute vaccines. They are a medical miracle that made it possible to cut the childhood death rate in half in the past two decades.” (Gates (2020).)

  295. 295.

    Kluger (2021). Cf., furthermore, Kluger (2020).

  296. 296.

    Cf. Kluger (2021). In a poll taken at the end of November, 75% of Democrats said they would be willing to take a Covid-19 vaccine, compared to 61% for Independents and 50% for Republicans. (Cf. Kluger (2021). For more details, cf. Brenan (2020).)

  297. 297.

    Kluger (2021).

  298. 298.

    Kluger (2021).

    In the December Pew Research Center poll, e.g., 75% of adults over 65 reported that they intended to be vaccinated, compared to just 55% under 30. (Cf. Kluger (2021).)

  299. 299.

    Kluger (2021). Cf., furthermore, Brenan (2020).

    According to Kluger, unwillingness to get vaccinated among Black Americans is the result of a long history of medical disenfranchisement and practices that are even much worse. A part of the mistrust dates back as far as infamous gynecological experiments undertaken by J. Marion Sims conducted on enslaved women—without anesthetic—in the nineteenth century. Kluger, furthermore, refers to the Tuskegee experiment that started in the 1930s and that involved decades of studying the progress of syphilis in Black men, without informing them that they had the disease or offering them the antibiotics needed to treat it. The structural inequality and bias with regard to enforced medical practices continues until this very day. (Cf. Kluger (2021).)

  300. 300.

    Brenan (2020).

  301. 301.

    USAFACTS (2021); data update of 3 March 2021, as accessed on 6 March 2021.

  302. 302.

    USAFACTS (2021); data update of 3 March 2021, as accessed on 6 March 2021.

  303. 303.

    USAFACTS (2021); data update of 3 March 2021, as accessed on 6 March 2021.

  304. 304.

    Julie (2021).

  305. 305.

    Elflein (2021).

  306. 306.

    USAFACTS (2021); data update of 3 March 2021, as accessed on 6 March 2021.

    This disparity could partly be explained by distribution of vaccines. The federal government’s initial allocation of vaccines was based on a state’s 18-and-over population. (The Moderna and Johnson & Johnson vaccines were only approved for adult use, while the Pfizer/BionNTech vaccine was approved for those 16 and older). Utah had at that date a smaller proportion of adults in its population, and therefore was being allocated fewer vaccines.

  307. 307.

    USAFACTS (2021); data update of 3 March 2021, as accessed on 6 March 2021.

  308. 308.

    The White House Briefing Room (2021a).

  309. 309.

    The White House Briefing Room (2021a).

  310. 310.

    The White House Briefing Room (2021a).

  311. 311.

    It was further reported that on Saturday, March 6, 2021, the United States had set an all-time, single-day record: nearly 3 million Americans had been vaccinated—“a pace seen nowhere else in the world”. (Cf. The White House Briefing Room (2021a).)

  312. 312.

    The White House Briefing Room (2021a).

  313. 313.

    The White House Briefing Room (2021a).

  314. 314.

    The White House Briefing Room (2021a).

  315. 315.

    McKeever and National Geographic Staff (2021).

  316. 316.

    McKeever and National Geographic Staff (2021).

  317. 317.

    McKeever and National Geographic Staff (2021).

  318. 318.

    McKeever and National Geographic Staff (2021).

  319. 319.

    Reklaitis and Schroeder (2021), containing a video recording of the press conference.

  320. 320.

    Cf. The White House Briefing Room (2021b).

  321. 321.

    However, this equity applied only with regard to mutual relations between Americans among each other, and not to the relationship of the United States and its citizens with the rest of the world. In the latter relationship, the America(ns) first principle simply continued to apply, even though President Biden himself had criticised his predecessor President Donald Trump, for having adhered to this principle too much. (Cf. Bowden (2021).)

    We shall return to this point in Sect. 9.6.

  322. 322.

    The White House Briefing Room (2021b).

    According to the further information provided by The White House, already in the preceding two months, 60% of the Covid-19 vaccine doses administered at federally run community-based vaccination centers had been administered to people of color. In addition, under the federal retail pharmacy programme, 45% of these sites were located in postcodes with high social vulnerability scores. Finally, over 65% of federal doses distributed to community health centers had been intended for administration to people of colour. (Cf. The White House Briefing Room (2021b).)

  323. 323.

    The White House Briefing Room (2021b).

  324. 324.

    CDC (2021b), as accessed on 8 April 2021.

  325. 325.

    CBS News (2021).

  326. 326.

    Luscombe (2021).

  327. 327.

    Luscombe (2021).

  328. 328.

    Luscombe (2021).

  329. 329.

    Luscombe (2021).

    In a June 2020 Pew survey, 58% of the surveyed respondents had still said that the Covid-19 pandemic was at the top of the list of concerns, a figure that had fallen to 47% in the April 2021 survey, as more American adults got vaccinated and states began to reopen again. Also in April 2021, health care affordability (56%), the federal budget deficit (49%) and illegal immigration (which has risen from 28% to 48%) were all considered topics of greater concern to Americans than the Covid-19 pandemic. (Cf. Luscombe (2021).)

  330. 330.

    It was however pointed out that the survey had been conducted just before Johnson & Johnson’s Covid-19 vaccine rollout was suspended in early April 2021. (Cf. Sect. 9.3.1.3.; cf., furthermore, Luscombe (2021).)

  331. 331.

    Luscombe (2021).

  332. 332.

    Luscombe (2021).

    A recurring theme of Biden’s January 2021 inaugural speech had been “unity”, which had formed a response to the turbulence and divisions of the four years of the Trump administration and to the events during the presidential campaigns of 2020 and their aftermath. According to President Biden, Americans needed to “show respect to one another. Politics need not be a raging fire destroying everything in its path. Every disagreement doesn’t have to be a cause for total war.” (Cf. Luscombe (2021).)

    In terms of his own personal conduct, President Biden appeared to be making progress. More Americans (44%) had declared that they liked the way Biden conducts himself than did not (27%), with another 27% having mixed feelings. Meanwhile, 46% had indicated that Biden had changed the tone of political debate for the better, with 29% indicating for the worse and 27% declaring that they saw little change. According to the Pew study, on both matters there were sizable differences in views of Biden and Trump. In 2020, only 15% of the participants to the Pew survey had declared that they liked the way Trump conducted himself as president, a figure that barely fluctuated throughout his presidency. In 2019 and 2020 surveys, 55% of the surveyed people had said that Trump had changed political debate in the United States for the worse. (Cf. Luscombe (2021).)

  333. 333.

    The survey was conducted from 11 February to 7 March 2021, by which time the Pfizer-BioNTech and Moderna Covid-19 vaccines had already received the FDA EUA. Johnson & Johnson’s single-dose Covid-19 vaccine was licensed during the survey field period, notably on 27 February 2021. (Cf. Kirzinger et al. (2021).)

  334. 334.

    Cf. Kirzinger et al. (2021).

  335. 335.

    Kirzinger et al. (2021).

  336. 336.

    Kirzinger et al. (2021).

    Although the KFF Vaccine Monitor found a steady increase in the proportion of black and Hispanic adults who reported having been administered a vaccine against Covid-19, or who indicated that they would get vaccinated as soon as they had access to a Covid-19 vaccine, these populations remained more likely than white adults to say that they were waiting to see how the Covid-19 vaccines would work for other people before getting vaccinated themselves. (Cf. Kirzinger et al. (2021).)

  337. 337.

    Kirzinger et al. (2021).

  338. 338.

    Glenza (2021).

  339. 339.

    Glenza (2021).

    Glenza referred to measles as a classic example. According to Glenza, being one of the most contagious viruses known to humans, measles has already for years a very safe and effective vaccine, which prevents 93% of cases. The huge degree of infectiousness of measles implies that a very high proportion of the population needs to be vaccinated in order to prevent breakout infections—about 95%, according to the WHO. With more than 90% of the American population inoculated against measles which is a very high vaccination rate—this is still not enough for preventing localized outbreaks in social groups characterized by lower vaccination rates. These outbreaks can then spill over into the larger community. (Cf. Glenza (2021).)

  340. 340.

    Glenza (2021).

  341. 341.

    Glenza (2021).

  342. 342.

    Glenza (2021).

  343. 343.

    Cf. Kaiser Family Foundation (2021).

    By May 2021, especially US conservative states still proved hesitant to get vaccinated. Among adults, 20% of these told surveyors with the Kaiser Family Foundation that they would either “definitely not” (13%) get a Covid-19 vaccine, or only do so “if required” (7%). Another 17% said that they would “wait and see” whether to get the vaccine. In all of this, republicans remained the most vaccine hesitant group. (Cf. Kaiser Family Foundation (2021).)

    As the Kaiser Family Foundation (2021), as accessed on May 5, 2021, reported: “When asked separately about each of the three FDA authorized COVID-19 vaccines, majorities of those planning or considering getting vaccinated say they would be open to getting each one. About seven in ten say they would “probably” or “definitely” get each of the three vaccines, including at least one-third who say they would “definitely get” each. About one in seven say they would definitely not get each of the vaccines. (Note: This survey was conducted before distribution of the J&J vaccine was paused).” (Kaiser Family Foundation (2021).)

  344. 344.

    Glenza (2021).

  345. 345.

    Glenza (2021).

  346. 346.

    Deutch and Wheaton (2021).

  347. 347.

    McPhillips (2021). Cf., furthermore, Byttebier and Vanstraelen (2021).

  348. 348.

    Byttebier (2017), pp. 1–11.

  349. 349.

    Deutch and Wheaton (2021).

  350. 350.

    Deutch and Wheaton (2021).

  351. 351.

    Deutch and Wheaton (2021).

  352. 352.

    Deutch and Wheaton (2021).

  353. 353.

    Deutch and Wheaton (2021).

    According to Deutch and Wheaton, a meeting of 2 March 2020 that gathered in the White House Cabinet room started to cause waves throughout Europe, in particular in Berlin, where German journalists zeroed in on a pitch purportedly made to US President Trump by Daniel Menichella, CEO of “CureVac”, a German biotech firm. At that time, CureVac had developed an experimental rabies vaccine by resorting to a new mRNA technology that instructs a body’s cells to train the immune system in order to fight off a virus. According to Menichella, the enterprise’s vaccine could be reengineered for fighting of the Covid-19 virus in just a few months times. As a result, German health ministry officials were left alarmed that, already as early as the beginning of March 2020, the American president had offered CureVac “large sums of money” in exchange for exclusive dibs on a-the-time-still-nonexistent Covid-19 vaccine. But a few days later, on 16 March 2020, the EU Commission President Ursula von der Leyen and the European Investment Bank’s vice president for innovation Ambroise Fayolle held a virtual face to face with CureVac’s management. Both the enterprise and the White House denied any attempt by the United States to monopolize the potential CurVac vaccine. Nevertheless, both von der Leyen and Fayolle were said to be sufficiently spooked afterwards and announced plans to offer CureVac up to EUR 80 million in loans to test and manufacture its vaccine in Europe—even without having assessed the business case at hand. Fears that the United States would monopolize Covid-19 remedies would continue to dominate the discussion at the European Council of the day after, when EU leaders met for one of their first Covid-era videoconferences. At a subsequent press conference, von der Leyen crowed about convincing CureVac to stay in Europe, bragging that it was the front-runner in the field of Covid-19 vaccination research. (Cf. Deutch and Wheaton (2021).)

    This would later prove to be but one of the EU’s many early mistakes in securing access to the Covid-19 vaccines, because, in reality, CureVac was well behind American, British, and even European competitors, such as another medium-sized German firm, named “BioNTech” which would be among the first to successfully develop an mRNA based Covid-19 vaccine (cf. Deutch and Wheaton (2021)). Indeed, while normally focusing on cancer research, in a joint press release with Pfizer (cf. https://investors.pfizer.com/investor-news/press-release-details/2020/Pfizer-and-BioNTech-to-Co-Develop-Potential-COVID-19-Vaccine/default.aspx), BioNTech would already on 17 March 2020 announce that it would team up with the American behemoth Pfizer to manufacture its mRNA-based Covid-19 vaccine. (Cf. Deutch and Wheaton (2021).)

    In the further opinion of Deutch and Wheaton, behind von der Leyen’s first (public) Covid-19 vaccination mistake lay a startling truth: Europe was already as early as March 2020 losing the race to secure access to the Covid-19 vaccine candidates. This was in particular due to the fact that, as early as mid-February 2020, while the US President Donald Trump was downplaying the threat posed by the Covid-19 virus before the cameras, his government was nevertheless making firm connections with America’s in the field of vaccine development leading pharmaceutical enterprises, such as Pfizer, Moderna and many others. As a further example, the US “Biomedical Advanced Research and Development Authority” had already on 11 February 2020 teamed up with Johnson & Johnson to look for Covid-19 vaccines and a collaboration with the French leading pharmaceutical enterprise “Sanofi” would be announced only a week after that. (Cf. Deutch and Wheaton (2021).)

  354. 354.

    Deutch and Wheaton (2021).

  355. 355.

    Deutch and Wheaton (2021). Cf., furthermore, Herszenhorn and Paun (2020).

    While the fundraising event was portrayed partly as an effort to guarantee that developing countries would not be left out while rich nations would start benefiting from newly developed Covid-19 treatments and vaccines, some global public health experts were particularly and to an increasing extent concerned about the fact that wealthier nations would end up fighting among themselves, as leaders faced pressure to protect their own citizens. (Cf. Herszenhorn and Paun (2020).) In this regard, the Trump administration’s unwillingness to join the common effort, obviously, even raised more concern around the world about his intentions. (Cf. Herszenhorn and Paun (2020).) However, already by the end of December 2020, said intentions would become quite clear, as the United States had by had gotten a sufficient access to Covid-19 vaccines to successfully initiate its Covid-19 campaign, with a clear intent of having all senior and adult Americans vaccinated within a period of more or less half a year, at a time when the EU was facing huge shortages so it could not even successfully vaccinate the risk groups among its population.

  356. 356.

    Deutch and Wheaton (2021).

  357. 357.

    Deutch and Wheaton (2021). Cf., furthermore, Maçães, referring to the “Covid-19 vaccination race” as: “an ugly global race for enough doses in which the losers are denied a quick path out of the pandemic.” (Maçães (2021).)

  358. 358.

    Deutch and Wheaton (2021).

  359. 359.

    Deutch and Wheaton (2021).

  360. 360.

    Deutch and Wheaton (2021).

  361. 361.

    Deutch and Wheaton (2021).

    Some enterprises were reported “to take a page from the CureVac playbook”: capitalize on the FOMO (or, in full, “the fear of missing out”). E.g., the United States’ early investment in Sanofi’s vaccine candidate would again translate into priority access for Americans. In the meantime, another front-runner in the vaccine race had been emerging. More in particular, Oxford researcher Sarah Gilbert told The Times on, 11 April 2020, that the Covid-19 vaccine candidate that she was developing in cooperation with AstraZeneca could be ready by September 2020, while expressing a “80 percent confidence” that it would work. (Cf. Deutch and Wheaton (2021).)

  362. 362.

    Deutch and Wheaton (2021).

  363. 363.

    Deutch and Wheaton (2021).

  364. 364.

    Deutch and Wheaton (2021).

    The agreement with Oxford-AstraZeneca was described as little more than a one-page term sheet between AstraZeneca and the health ministers of the countries involved. Nevertheless, the agreement was politically extremely important. It demonstrated that the four countries of the Vaccine Alliance—which represented four of the EU’s five largest economies and about a third of the EU’s total population—were not afraid to use their significant purchasing power and to leverage their powerful pharmaceutical industries, even at a moment in time when the European Commission itself still did not know what it was doing. The Vaccine Alliance declared that it would continue to discuss with the European Commission the possibility of working together “as far as possible” and that other countries might join, but “the four countries realised at some point that it was not time to wait until everyone was on board,” declared a senior European diplomat from one of the Vaccine Alliance countries. (Cf. Deutch and Wheaton (2021).)

  365. 365.

    Deutch and Wheaton (2021). Cf., furthermore, Deutch (2020).

  366. 366.

    Deutch (2020).

    In a private WhatsApp group, some EU diplomats half-joked that the big countries would monopolise all the Covid-19 vaccines—a sign that many did not trust the “inclusive” Vaccine Alliance to be truly all that inclusive. One EU diplomat outside the alliance declared that other countries had feared that there would be two competing tracks: one with the alliance, the other, supported by the European Commission, consisting of Spain and the poorest EU countries. (Cf. Deutch and Wheaton (2021).)

  367. 367.

    Deutch and Wheaton (2021).

  368. 368.

    Deutch and Wheaton (2021).

    Only a few hours after Kyriakides presented her strategy, the much discreter announcement was made that Sandra Gallina, Deputy Director General of the Commission’s Trade Department, would be taking over as head of DG SANTE’s Health Division, despite having no relevant health experience whatsoever. (Cf. Deutch and Wheaton (2021).)

  369. 369.

    Deutch and Wheaton (2021).

  370. 370.

    Deutch and Wheaton (2021).

  371. 371.

    European Commission (2020).

  372. 372.

    European Commission (2020).

  373. 373.

    European Commission (2020).

  374. 374.

    Van de Wiel (2021).

  375. 375.

    Deutch and Wheaton (2021).

  376. 376.

    European Commission (2020).

  377. 377.

    Cf. European Commission (2020), esp. under its Point 2.3. ”Selection criteria for vaccine candidates”.

  378. 378.

    Deutch and Wheaton (2021).

  379. 379.

    Deutch and Wheaton (2021).

    At the time, only Germany kept showing some more common sense and some more willingness to throw enough money at the problem. Specifically, Germany wanted to bet bigger on purchasing the mRNA vaccines. By mid-September, Berlin, hence, announced it was giving EUR 375 million to BioNTech and EUR 252 million to CureVac. (Cf. Deutch and Wheaton (2021).)

  380. 380.

    Deutch and Wheaton (2021).

  381. 381.

    Deutch and Wheaton (2021).

  382. 382.

    In an interview with AFP in November 2020, Moderna CEO Stéphane Bancel griped that dealing with 27 member countries was slowing everything down. CEO Bancel also declared that, in contrast, his company had wrapped a deal with Canadian authorities two weeks after starting talks. “A delayed order”, Bancel had, furthermore, said, “is not going to limit the total amount, but it is going to slow down delivery”. (Cf. France24 (2020).)

  383. 383.

    Deutch and Wheaton (2021).

  384. 384.

    France24 (2020).

  385. 385.

    France24 (2020).

  386. 386.

    France24 (2020).

  387. 387.

    France24 (2020).

  388. 388.

    Deutch and Wheaton (2021).

  389. 389.

    Wheeldon (2021).

  390. 390.

    Owen (2021).

  391. 391.

    National Review Editors (2021).

  392. 392.

    Wheeldon (2021).

  393. 393.

    Maçães (2021).

  394. 394.

    France24 (2020).

  395. 395.

    In fact, it appeared from the early start of the vaccination campaigns that the EU would only have access to enough of the mRNA vaccine-doses for inoculating its population, after the population of the countries that had ordered earlier would have been served first. As a result of all this, as of January 2021, the EU still had to make frantic efforts to conclude additional purchasing contracts with a view to acquiring the less performing vaccines, such as the Oxford-AstraZeneca vaccine.

  396. 396.

    Cf. McEvoy (2021), pointing to the fact that by 21 February 2021, roughly a dozen European countries had limited the Oxford-AstraZeneca Covid-19 vaccine for people over 65 due to a lack of data about its efficacy among older people.

  397. 397.

    Cf. McEvoy (2021), reporting that, during the second half of February 2021, thousands of healthcare laborers throughout the EU were refusing to take the Oxford-AstraZeneca Covid-19 vaccine over concerns about side effects and efficacy, with some arguing that they should be prioritized for the more effective Covid-19 vaccine doses from BioNTech-Pfizer and Moderna. McEvoy even pointed to the fact that, mid-February 2021, a group representing 3000 doctors in Italy had written a letter to the Italian government demanding that “private doctors and dentists be inoculated with mRNA vaccines” like those developed by Moderna and Pfizer and BioNTech, as opposed to AstraZeneca’s because of the evidence the latter were more effective. Around the same time, Germany and France both reported that hundreds of thousands of Oxford-AstraZeneca vials were sitting unused, as many skipped vaccination appointments for Oxford-AstraZeneca’s doses specifically. (Cf. McEvoy (2021).)

    By mid-March 2021, the same scenario occurred in Canada (cf. McCully (2021)), and one more month later, again in Australia, with, on 22 April 2021, the Sydney Morning Harold reporting that most NSW healthcare workers who had been booked for the Oxford-AstraZeneca Covid-19 vaccine had cancelled their appointments following advice which recommended the BioNTech-Pfizer shot for under-50s, leaving one Sydney hospital delivering no vaccinations in a week. (Cf. Ward (2021).)

    Cf., furthermore, Pailliez and Ahlander (2021).

  398. 398.

    Franklin (2021).

  399. 399.

    Cf. on the Q&A website of the Flemish government https://www.laatjevaccineren.be/vaccinatie-tegen-covid-19-vraag-en-antwoord (accessed on May 15, 2021), where it was explicitly mentioned that people had no say whatsoever in the choice of the Covid-19 vaccine they were to receive.

  400. 400.

    By mid-February 2021, this was reported to be the policy of many European countries, resulting in many cases in people not turning up to appointments to get the Oxford-AstraZeneca Covid-19 vaccine. (Cf. Pailliez and Ahlander (2021).)

  401. 401.

    Deutch and Wheaton (2021).

  402. 402.

    News from Pfizer (2020).

  403. 403.

    Deutch and Wheaton (2021).

  404. 404.

    Deutch and Wheaton (2021).

  405. 405.

    Deutch and Wheaton (2021).

  406. 406.

    Deutch and Wheaton (2021).

  407. 407.

    Deutch and Wheaton (2021).

  408. 408.

    Deutch and Wheaton (2021).

  409. 409.

    Deutch and Wheaton (2021).

  410. 410.

    Deutch and Wheaton (2021).

  411. 411.

    Deutch and Wheaton (2021).

  412. 412.

    Deutch and Wheaton (2021).

  413. 413.

    Deutch and Wheaton (2021).

  414. 414.

    Deutch and Wheaton (2021).

  415. 415.

    Deutch and Wheaton (2021).

  416. 416.

    Deutch and Wheaton (2021).

    Washington and Brussels have since added hundreds of millions of doses to their orders.

  417. 417.

    Deutch and Wheaton (2021).

  418. 418.

    Deutch and Wheaton (2021).

  419. 419.

    Deutch and Wheaton (2021).

  420. 420.

    Deutch and Wheaton (2021). Cf., furthermore, Guarascio and Chalmers (2021).

  421. 421.

    Guarascio and Chalmers (2021).

  422. 422.

    Deutch and Wheaton (2021).

  423. 423.

    Deutch and Wheaton (2021).

  424. 424.

    Regev (2021).

    Israel has indeed made no secret of the reasons behind the success of its vaccination program: already on 7 January 2021, Netanyahu revealed that Israel had struck an agreement with Pfizer-BioNTech to exchange Israelian citizens’ data in exchange for 10 million doses of the BioNTech-Pfizer Covid-19 vaccine, including a promise of shipments of 400,000–700,000 doses of the vaccine per week. Under this agreement, Israel was to provided details to Pfizer (as well as to the World Health Organization) about the age, gender and medical history of the people that would be receiving the BioNTech-Pfizer Covid-19 jab, as well as data on its side effects and efficacy. On 5 January 2021, Israelian officials had, furthermore, disclosed off-the-record that Israel had paid a price for the BioNTech-Pfizer Covid-19 vaccine of USD 30 per dose. That was more than twice the amount listed by Belgium, e.g., which had accidentally revealed its Covid-19 vaccine price list when Belgium’s secretary of state had tweeted it by mistake. (Cf. Regev (2021). Cf., furthermore, Winer (2021).)

    According to Winer, the price tag per person for the Covid-19 vaccines that Israel had acquired from the Pfizer-BioNtech and Moderna pharmaceutical enterprises had amounted to USD 47 per person. In total, the country was reported to have paid NIS 1 billion (USD 315 million) to the manufacturers for their two-shot vaccination products. Pfizer was reported to have received NIS 775 million (USD 245 million), whereby it was also indicated that the bulk of Covid-19 vaccines to be used for the Israelian vaccination campaign were expected to come from Pfizer-BioNTech. Moderna was reported to have received NIS 320 million (USD 101 million). These sums imply that the average price for each dose of a Covid-19 vaccine from the vaccine producing enterprises was about USD 23.50, slightly higher than the amount that Pfizer had initially said the shots of its Covid-19 vaccine would cost. The higher price was because Israel had pushed to buy large numbers of the Covid-19 vaccines and to have them delivered quickly to keep the vaccination drive in Israel in high gear. These prices, furthermore, indicated that Israel had been paying significantly more for the BioNTech-Pfizer Covid-19 vaccine than either the United States or the EU. It had been reported before (by the Washington Post) that the United States had been paying Pfizer-BioNTech USD 19.50 per dose, while the EU 27-country bloc was paying a mere USD 14.76 per dose. The same source cited the Moderna Covid-19 vaccine prices at USD 15 per dose for the United States and USD 18 per dose for the EU. (Cf. Winer (2021).)

  425. 425.

    Deutch and Wheaton (2021).

  426. 426.

    Deutch and Wheaton (2021).

  427. 427.

    Münchau (2021).

  428. 428.

    Münchau (2021).

  429. 429.

    https://mobile.twitter.com/GuntramWolff/status/1352899970517626880.

  430. 430.

    Deutch and Wheaton (2021).

  431. 431.

    Cendrowicz (2021).

  432. 432.

    Wheeldon (2021).

  433. 433.

    Deutch and Wheaton (2021).

  434. 434.

    Guarascio and Chalmers (2021).

  435. 435.

    Cf. Guàrdia et al. (2021) have made the following remarks in this regard: “The European Commission wants 70 percent of all adults in the EU to get the coronavirus jab by the summer. At this point, that goal is wildly off. If the current pace of vaccination persists, the bloc as a whole would reach only 15 percent by the end of September. Based on the average of the past week, the bloc would have to ramp up vaccination by a factor of five to hit its target. The vaccination goal is part of a list of non-binding recommendations from the Commission. Health Commissioner Stella Kyriakides described this target on Tuesday as “ambitious,” but the Commission has resisted offering a specific date for the summer cut-off. A Commission official told POLITICO that they meant the end of the summer, so September 22 has been used for the calculations in this article. The catch: At the current pace, the EU as a whole wouldn’t hit that target until March 2024. On the extreme end is Bulgaria, which wouldn’t get there until 2040 and would need to pick up vaccination by a factor of 29. Latvia would need to accelerate its pace by a factor of 17; Italy by 10; and Hungary by nine. So far, Malta is the EU champion: It could meet the Commission’s target in time if it doubled its number of daily doses. The U.K., which is no longer a member of the bloc and started vaccinating a few weeks earlier than the EU, will have vaccinated 83 percent of adults by the end of the summer if it maintains its current pace.” (Guàrdia et al. (2021).)

  436. 436.

    Maçães (2021).

  437. 437.

    van de Wiel (2021).

  438. 438.

    Khan and Peel (2021).

  439. 439.

    Khan and Peel (2021).

  440. 440.

    van de Wiel (2021).

  441. 441.

    Szucs (2021).

  442. 442.

    Franklin (2021).

  443. 443.

    Only since the emergence of the climate change debate has the EU started to pay some more consideration on matters such as the protection of the environment, which in 2020 resulted in the announcement of the so-called Green Deal, an according to EU standards ambitious action program for fighting climate change. (Cf. https://ec.europa.eu/info/strategy/priorities-2019-2024/european-green-deal_en. Accessed on 15 May 2021).

  444. 444.

    Indeed, notwithstanding anyone with an ounce of common sense should be aware that the pharmaceutical sector, after decades of neoliberal policies (both in the United States and in Europe), is interested in nothing else than big money making, has been living with its head in the sand for the past quarter of a century, thus apparently the EU officials who were in charge of the procurement of the Covid-19 vaccines for the entire EU.

    After all, Adam Smith, the guru of selfish economics, taught us that if everyone behaves as selfishly as possible, it will best serve everyone’s interests. Applied to the pharmaceutical sector, this implies that pharmaceutical enterprises are not to be expected to show any concern for public health, but only for their own financial profits which must be realized at all costs in the interests of their shareholders, whose excessive efforts for the benefit of all of us, after all, should be rewarded as much as possible by paying out huge dividends. (Cf. Sect. 2.1).

    The EU should have realized all of this, as it has itself been one of the main architects of the implementation of this neoliberal way of thinking into binding rules and regulations.

  445. 445.

    Cf. Bloomberg and Weber (2021). Cf., furthermore, The Straits Times Editorial (2021), in which the following was stated on the matter: ““In vaccine economics there is only black or white: Economies that finish the race first will be rewarded with strong positive multiplier effects supercharging consumption and investment activity in the second half of 2021,” economists led by Ludovic Subran said in a report. “Vaccination laggards will remain stuck in crisis mode and face substantial costs - economic as well as political.” Nor will the pain be evenly distributed. For the hard-hit travel sector, even a partial opening around the Easter holidays at the beginning of April would bring much-needed revenue, according to Reinhard Cluse, an economist at UBS Group. Southern countries including Spain and Italy - already the worst-affected by the pandemic - will suffer most from a delay. “With the slow progress on vaccinations, it’s not clear we’ll have a good Easter season,” he said, adding that the summer is also under threat, as many travellers books their holidays in the spring and may opt to stay closer to home for another year. Each extra week the economy is subject to restrictions also increases the risk that companies that ate into their financial buffers for the last year will be pushed over the edge and file for insolvency. That would raise unemployment and undermine the prospect of rapid rebound. The EU could still catch up with its peers, or all nations could yet be plunged into another crisis, for example if coronavirus mutations emerge that are resistant to the current vaccines. On current form though, the likelihood is that continental Europe is headed for a painful reckoning. “To the extent that we don’t get the necessary run rates in the coming weeks and months, our concerns will rise on a daily basis,” said Cluse.” (The Straits Times Editorial (2021).)

  446. 446.

    Krugman (2021).

  447. 447.

    European Centre for Disease Prevention and Control (2021b), p. 6.

  448. 448.

    European Centre for Disease Prevention and Control (2021b), p. 6.

  449. 449.

    European Centre for Disease Prevention and Control (2021b), p. 6.

    As of 7 February 2021, a total of 29 EU/EEA countries reported full or partial data on the progress of their Covid-19 vaccination campaigns on TESSy. Among the 29 reporting countries, the estimated uptake of the first dose of a Covid-19 vaccine among adults (18 years and older) ranged from 0.3% to 7.6% (median: 3.5%). Among the 29 countries reporting information to TESSy, uptake of two doses of a Covid-19 vaccine among adults (18 years and older) ranged from 0.2% to 3% (median: 1.1%). (Cf. European Centre for Disease Prevention and Control (2021b), p. 6.)

    Between mid-December 2020 and January 2021, ECDC and the European Commission’s Directorate-General for Health and Food Safety jointly organised a stress test with regard to the logistical aspects of the Covid-19 vaccination roll-out plans. The exercise was conducted in two phases, involving twelve EU/EEA Member States. The stress test concerned a targeted simulation exercise in which participating countries were asked to describe their deployment plans for delivering a Covid-19 vaccine with strict cold chain requirements to their target priority groups. All participating Member States were able to describe the process, although with varying levels of detail, indicating that they were at different stages of planning. (Cf. European Centre for Disease Prevention and Control (2021b), p. 6.)

  450. 450.

    The Straits Times Editorial (2021). Cf., furthermore, Bloomberg and Weber (2021).

  451. 451.

    The Straits Times Editorial (2021).

  452. 452.

    “Every week that the lockdown has to be extended because the population isn’t vaccinated and vulnerable means substantial economic costs,” said Guntram Wolff, director of the Bruegel think tank in Brussels. “Those costs are a lot higher than the costs of the vaccinations themselves.” (The Straits Times Editorial (2021).)

  453. 453.

    The Straits Times Editorial (2021). Cf., furthermore, Bloomberg and Weber (2021).

  454. 454.

    Cf. Verschelden (2021).

  455. 455.

    Smith (2021).

  456. 456.

    Cendrowicz (2021); Smith (2021).

    According to Smith: “A YouGov study in late February showed that Europeans were already more wary of the AstraZeneca vaccine, which hadn’t seen nearly the same level of growth in confidence that the Pfizer and Moderna alternatives had in the preceding months. Nevertheless, in all countries studied except for France, more people considered the AZ vaccine to be safe than unsafe. That is no longer the case. In the four continental European countries studied in both the February and March surveys – France, Germany, Spain and Italy – people are more likely to see the vaccine as unsafe than safe. In each case this represents a substantial decline in perceived safety. In our previous survey in Germany, 43% said they believed the vaccine to be safe, compared to 40% who considered it unsafe. As of now, a majority of Germans think the vaccine is unsafe (55%) and just a third think it safe (32%). In France, where people had already considered the vaccine unsafe (43%) than safe (33%), those figures have now worsened to 61% unsafe and 23% safe. In Italy and Spain, most people had previously felt that the AstraZeneca vaccine was safe (54% and 59% respectively). Since then those numbers have fallen to 36% and 38% - in both cases lower than the proportion who feel the vaccine is unsafe. Only in Britain can the blood clots story be considered to have little to no impact, with the vast majority still considering the vaccine safe, at 77% (down 4pts from February, and still on a par with Pfizer’s 79% safe rating). New entrants to the survey this month are Sweden and Denmark. In Sweden the AstraZeneca vaccine is still seen as safe by more people than not (43% vs 34%), while Danes are tied 42%-42%. In both cases, however, the drug is seen as safe by far fewer people than the Pfizer and Moderna alternatives.” (Smith (2021).)

  457. 457.

    Bremmer (2021).

  458. 458.

    Bremmer (2021).

    According to Bremmer, the EU’s Covid-19 vaccine export generosity was especially pronounced, compared to countries like the United States, where there were virtually no Covid-19 vaccine exports allowed before the summer of 2021. This has been mainly attributed to the fact that, in the United States—even after Donald Trump had left office as president–, “the Americans first policy” was prevailing more than ever. However, the fact was also true compared to the United Kingdom, which, despite having no formal export ban, had secured priority delivery from AstraZeneca as part of its purchasing agreement, adding even further to the reasons for the repeated surprise cuts to the EU supply (in addition to production delays in European plants). All of this implied that, by mid-March 2021, the delivery delays with regard to the Oxford-AstraZeneca Covid-19 vaccine ran into the tens of millions of doses that had failed to arrive since the start of the year. In contrast, 10 million Covid-19 vaccine doses sent to the United Kingdom had originated from the EU. (Cf. Bremmer (2021).)

  459. 459.

    In a Press Release of March 11, 2021, the EU Commission had mentioned: “The EU continues to be the leading provider of vaccines around the world. Six weeks into the existence of this mechanism, 249 export requests to 31 different countries have been granted for a total of 34,090,267 doses, as they did not threaten the contractual engagements between the EU and the vaccine producers. Only one export request was not granted. The main export destinations include the United Kingdom (with approximately 9.1 million doses), Canada (3.9 million), Mexico (3.1 million), Japan (2.7 million), Saudi Arabia (1.4 million), Hong Kong (1.3 million), Singapore (1 million), United States (1 million), Chile (0.9 million) and Malaysia (0.8 million).” (Cf. European Commission (2021)).

  460. 460.

    It was not of much help that the UK’s smug triumphalism about its Covid-19 vaccine rollout added a further sting in the already febrile post-Brexit era. The numbers on the Covid-19 vaccine exports incensed people across the EU, as they imagined the EU bloc leaching doses of the Covid-19 vaccines to everyone else than the own EU population. A French official even warned that the EU should no longer be the pandemic’s “useful idiot”—these had been the words of an adviser to the French President (cf. Reuters Staff (2021))—while other countries, such as the United States and the United Kingdom, hoarded and hid heaps of the vaccines. The United Kingdom itself had not been exporting any Covid-19 vaccines, and it had craftily written clauses into its purchasing agreements with the Covid-19 vaccine manufacturer AstraZeneca to be prioritized above everyone else. As for the United States, it also prioritized domestic orders by drawing on the 70-year-old “Defence Production Act” which granted the executive power extraordinary powers over manufacturing in times of crisis. The strategies deployed by the United Kingdom and the United States raised the question why the EU and/or the EU Member States did not start using the similar legal tools at their disposal. The argument for a more assertive EU policy got louder when the travails with AstraZeneca were raised even sharper: by 25 March 2021, the Anglo-Swedish pharmaceutical giant had only delivered 30 million of its promised (and already reduced number of) 120 million doses, and yet continued to provide uninterrupted supply to United Kingdom, still sourcing from its factories located in the EU itself. (Cf. Cendrowicz (2021).)

  461. 461.

    Tallis (2021).

    Shortly before, Austrian Chancellor Sebastian Kurz had declared that the Covid-19 vaccine doses were not being spread evenly among the EU Member States, despite an agreement within the bloc to do so in accordance with levels of population. He blamed, albeit without offering evidence, separate deals that had purportedly been struck between the EU’s vaccination steering board and individual drug enterprises. (Cf. Tallis (2021).)

  462. 462.

    Meier (2021). Cf., furthermore, dpa.international (2021), where parts of the interview appear in English: ““It is true that mistakes were made when ordering the vaccines in Brussels as well as in the member states,” Timmermans told Germany’s Tagesspiegel newspaper in an interview released Sunday. “I am ready to take stock at the end of the pandemic - then we can see what we did wrong and what we did right,” he said. The first thing to do, however, is to ensure that “all of Europe gets vaccine,” Timmermans said. A European approach is “also in the interests of richer member states” like Germany, Commission President Ursula von der Leyen added in the interview.” (Cf. dpa.international (2021).)

  463. 463.

    National Review Editors (2021).

  464. 464.

    Cendrowicz (2021).

  465. 465.

    National Review Editors (2021).

  466. 466.

    National Review Editors (2021).

  467. 467.

    Xinhua (2021).

  468. 468.

    Xinhua (2021).

  469. 469.

    Mallet et al. (2021).

  470. 470.

    Nardelli (2021).

  471. 471.

    Xinhua (2021).

  472. 472.

    Xinhua (2021).

  473. 473.

    Xinhua (2021).

  474. 474.

    Nardelli (2021).

  475. 475.

    Dendrinou and Nardelli (2021).

  476. 476.

    Chrysoloras and Nardelli (2021).

  477. 477.

    Chrysoloras and Nardelli (2021).

  478. 478.

    Chrysoloras and Nardelli (2021).

  479. 479.

    Nicolás (2021).

    From data published by the European Centre for Disease Prevention and Control, it however appeared that Covid-19 vaccination rates were accelerating in a moderate manner in many Member States, but the figures were still falling well below the 80% threshold for people over 80. In Q1 2021, EU Member States had received 107 million doses of the Covid-19 vaccines, of which 89 million had been administered. As of 2 April 1921, the median uptake of a first dose of a Covid-19 vaccine among people aged 80 years and over was almost 57%, while full vaccination with two doses was only 30% (= figures about 23 EU Member States). For healthcare laborers, it appeared that the acceptance rate for the first dose was almost 63% and for the second dose 50% (= figures about only 11 EU countries). Surprisingly, Hungary had come out on top in the race to vaccinate the population against Covid-19 in the EU, but, as has been said, only because it had abandoned Brussels’ “solidarity diktat” and had started developing its own Covid-19 vaccination strategy, which included vaccines obtained through the EU, as well as the purchase of Covid-19 vaccines developed by Russia and China. As a result of this common sense, almost all (99%) of the health personnel in Hungary had been fully vaccinated. In addition, Romania, Spain, Estonia, and Ireland had vaccinated over 60% of their doctors and nurses. Meanwhile, Malta and Denmark were leading the EU in the race for vaccinating the elderly—with more than 50% of people aged 80 and over fully vaccinated. According to further estimates provided to Bloomberg, only 55% of the EU population was expected to be vaccinated by the end of June 2021. However, the figures also revealed significant disparities between EU Member States. E.g., Malta expected 93.1% of its population to be vaccinated by the end of Q2 2021, followed by Denmark with a forecast of 79.8%. But the Member States whose vaccination strategy relied heavily on the Oxford-AstraZeneca Covid-19 vaccine were sad to be completely running behind. (Cf. Nicolás (2021).)

  480. 480.

    Stevis-Gridneff (2021); Mueller et al. (2021).

  481. 481.

    Stevis-Gridneff (2021).

  482. 482.

    Stevis-Gridneff (2021).

  483. 483.

    Stevis-Gridneff (2021).

  484. 484.

    Mueller et al. (2021).

  485. 485.

    As explained before, AstraZeneca blamed production problems at its plant located in Belgium, which prompted fierce rebuttals from Brussels. (Cf., furthermore, Boffey (2021a); Sánchez Nicolás (2020); Mueller et al. (2021).)

  486. 486.

    Boffey (2021a); Sánchez Nicolás (2020); Mueller et al. (2021).

    According to legal experts, the “best efforts” clause in the purchasing agreement put the burden of proof on the EU and the 27 EU Member States that must prove that AstraZeneca has not acted with sufficient diligence to deliver the promised doses. But said experts also stated that this clause did not entirely shield AstraZeneca from a breach of contract. (Cf. Mueller et al. (2021).)

  487. 487.

    Boffey (2021b).

  488. 488.

    Boffey (2021b).

  489. 489.

    Boffey (2021b).

  490. 490.

    Boffey (2021b).

  491. 491.

    Boffey (2021b).

  492. 492.

    Boffey (2021b).

  493. 493.

    Boffey (2021b).

  494. 494.

    These negotiations had been conducted with the support of Thierry Breton, an industrialist and former French finance minister who was at the time the European Commissioner for the Internal Market. Under his leadership, the European Commission succeeded in convincing Pfizer-BioNTech to make deliveries to the EU earlier than planned, which basically caused a reversal in the EU vaccination campaign. (Cf. Boffey (2021b).)

  495. 495.

    Boffey (2021b).

  496. 496.

    Boffey (2021c).

  497. 497.

    Bingham (2021).

  498. 498.

    Syal (2020).

    At the time, Kate Bingham was said to have 30 years of relevant experience in the pharmaceutical industry. She, moreover, had a reputation for knowing her stuff. The daughter of the late Lord Tom Bingham, a former Lord Chief Justice described as the greatest lawyer of his generation, Kate Bingham had been educated at the independent St Paul’s girls’ school located in west London. One of her school mates was the Prime Minister’s sister, Rachel Johnson. Bingham went later on to study biochemistry at Oxford, before joining Harvard Business School. She was afterwards employed by the private equity firm SV Health Investors for nearly 30 years, where she was the managing partner and where her work had led to the launch of six new drugs for treating patients with inflammatory and autoimmune diseases and cancers. When asked to head the new UK Vaccine Task Force, she took the decision to temporarily retire from SV in order to be able to fully devote her time for working on the government’s vaccine task force. Prior to joining SV, Ms Bingham had worked in business development for Vertex Pharmaceuticals, a US biotech company, and Monitor, a strategy consultancy firm, which had given her a good understanding of the pharmaceutical sector. (Cf. Syal (2020).)

  499. 499.

    Bingham (2021).

  500. 500.

    Bolzen and Guerrera (2021); Smirmova (2021).

  501. 501.

    House of Commons (2021).

  502. 502.

    Smirmova (2021).

  503. 503.

    Smirmova (2021).

    Although this leadership style is believed to have been crucial for the success of the UK’s vaccination campaign (by having ensured a fast access to enough doses from the early start), it is also believed to have caused incomprehension among some officials. E.g., Bingham came under fire for allegedly spending more than £ 600,000 in taxpayers’ money on PR consultants. Her closeness to the Conservative Party also became a matter of some debate (as she is married to a Secretary of State in the Treasury and knows Boris Johnson from her time at Oxford University). (Cf. Smirmova (2021).)

  504. 504.

    Schiffling and Breen (2021).

    As explained before (cf. Sect. 2.4.2.3.5), the UK government’s manner of dealing with the Covid-19 pandemic has been criticized severely to the extent that the United Kingdom had been among the countries with the highest number of recorded Covid-19 contamination cases and Covid-19 related deaths. (Cf. Schiffling and Breen (2021).)

  505. 505.

    On 8 December 2020, Margaret Kee