Effective treatment of a pneumonic disease such as COVID-19 has to begin with ensuring that critical personal protective equipment (PPE) products are sourced and allocated to frontline health workers and other responders in affected areas. But the world’s PPE supply chain has not functioned properly to meet a surge in demand due to constraints in production and logistics (ADB 2020).
Over the years, as China has emerged as the world’s second-largest healthcare market after the United States, international pharmaceutical and medical device firms relocated production to the country to take advantage of lower labor costs in production and to more economically serve the needs of the local population. One account reports China to have “provided 43 percent of world imports of face shields, protective garments, mouth-nose-protection equipment, gloves, and goggles in 2018,” the year before the outbreak of COVID-19 (Bown 2020).
When COVID-19 was first detected in China, some of the world’s PPE inventory was sold and donated to meet the sudden surge in Chinese demand. Disruptions to cargo transportation resulting from government curtailment to interrupt the spread of the virus through human and cargo traffic also complicated the functioning of supply chains (Harvey 2020). The Chinese government responded by investing in massive production of PPE. As the supply shortage of PPE within China became less acute, China began to export it. Meanwhile, the deployment of PPE products in other countries needed to be approved through emergency use authorizations by their regulatory agencies, which must deal with a complex web of international, regional, and country standards (WHO 2020). China’s role as a supplier became controversial. Criticism surrounding China’s practice of “mask diplomacy,” is partly attributable to incompatibilities of technical standards. That criticism is also a reflection of “the dividing lines between advocates of engagement and containment with the country” (EIU 2020, 32).
But it is vaccines that are truly essential for a society to strike the balance between reducing disruptions to normal economic activities and daily life and protecting the health of the entire population. Although the severity of the pandemic differs from country to country, each society has to eventually move from containment to the treatment phases of COVID-19 control.
The onerous reality is that vaccine development is difficult, complex, highly risky, and costly. It includes clinical development, process development, and assay development. The risk is high because most vaccine candidates fail in preclinical or early clinical development and less than one in fifteen vaccine candidates entering Phase II achieves licensure. Full licensing requires demonstration of safety and effectiveness during Phase III clinical trials. After a vaccine is approved and released, optional Phase IV trials continue to test the vaccine for safety, efficacy, and other potential uses. Under normal circumstances, a successful vaccine takes up to fifteen years to complete a development cycle (Plotkin 2018).
To develop a COVID-19 vaccine, scientists around the world immediately began analyzing genetic sequencing data publicly posted by Yongzhen Zhang of the Shanghai Public Health Clinical Center & School of Public Health, Fudan University, on January 11, 2020 (Cohen 2020). According to a timeline of events published by the Xinhua News Agency, on January 24, 2020, the WHO acknowledged receipt of relevant genetic data China had shared (Xinhua 2020). More data became available as cases began to appear around the world, enabling laboratory research for designing vaccines. By the middle of 2020, governments in Europe and the United States started to place advance orders for hundreds of millions of doses of vaccines upon successful development. Although such monetary commitments can incentivize vaccine developers to take on risk, at least in the initial stage of successful development, vaccines will be limited in supply, given the global spread of the pandemic. Poorer parts of the world stand to suffer from practices of “vaccine nationalism” (FT 2020).
Concerns about lack of equal and equitable access to vaccines are valid, because even without the disruption of a pandemic, people in many countries, especially those in the developing world, traditionally struggle to gain timely access to vaccines for new diseases. As noted by the WHO (WHO undated):
About 80% of global vaccine sales come from five large multinational corporations…Many of the individual vaccine markets are monopolies or oligopolies, either by product or presentation. The limited number of vaccine suppliers and production capacities leads to a tenuous balance between demand and supply in many individual vaccine markets.
International organizations, since the mid-1970s, have played a key role in expanding vaccine access worldwide, with the WHO certifying prequalified products for countries without indigenous development and manufacturing capacities to procure from a pool of supply. The United Nations International Children's Emergency Fund (UNICEF), in addition to philanthropic entities, also assists by securing supply from multinational vaccine producers and offering the products to developing countries as donations and/or at discounted prices. In turn, many developing countries enter into advanced purchase guarantee arrangements for suppliers to deal with potential losses of income due to mutation of the targeted viruses or other medical circumstances that warrant termination of vaccine use.
The critical issue in the international circulation of vaccines is the physical availability of supply. With “government use” being a principle of action allowed under international medicine trade arrangements such as Trade-Related Aspects of Intellectual Properties (TRIPS), history is replete with examples of developed countries exercising sovereign exclusivity—including among friends and allies—over influenza vaccines that populations in many countries would have to rely on (Fidler 2010).
A prime example of “vaccine nationalism” in the recent past is competition for access to H1N1 vaccines in 2009. Developed countries placed large-scale, advanced marketing commitments for it and bought virtually all the vaccines that companies could manufacture. The WHO negotiated with vaccine manufacturers and developed countries to secure some vaccines for developing countries. The WHO and the United Nations (UN) also appealed for monetary donations to purchase vaccines and other supplies for use in affected low-income countries. Manufacturers did agree to make donation pledges, “but the donations still left the developing world with limited supplies, compared to developed countries, which would retain, even after donations, sufficient vaccine to cover their populations” (Fidler 2010). During the 2009 H1N1 influenza pandemic, the United States and many European countries donated 10% of their vaccine stocks to poorer countries, but only after it became clear they had enough for their own populations. During the H1N1 pandemic in 2009, developing countries lucked out due to the unexpectedly short duration of the disease’s spread.
To avoid a repetition of the 2009 H1N1 scenario, in early June 2020, the WHO, Global Alliance for Vaccines and Immunizations (GAVI), and Coalition for Epidemic Preparedness Innovations (CEPI) jointly set up a system to accelerate and equitably distribute vaccines, known as the COVID-19 Vaccines Global Access (COVAX) Facility. The goal is to have 2 billion doses by the end of 2021, enabled by advance purchase commitments and donations from governments and international organizations. Under the scheme, dosages are to be sold according to a country’s per capita income. High and upper-middle-income countries pay the full price which is agreed upon with manufacturers, whereas low and lower-middle-income countries are asked to purchase at subsidized prices. At the time of this writing, 190 countries have joined the COVAX Facility.
China, with its own vaccine candidates in the race, participated in demonstrations of solidarity such as the Global Vaccine Summit on June 4, 2020, at which world leaders including those from Canada, Germany and the United Kingdom, together with the Bill and Melinda Gates Foundation, pledged to make financial contributions and offer millions of doses of COVID-19 vaccines as part of the Gavi COVAX Advance Market Commitment (Lancet 2020). Then, in October 2020, China announced its decision to join the COVAX Facility.
China’s acts came on the heels of President Xi Jinping offering to provide $2 billion over two years to support the fight against the COVID-19 pandemic in a speech to the World Health Assembly (the governing body of the WHO) in early May 2020. Xi announced that China was going to make its COVID-19 vaccines, when successful, a public good for global health. He also stated that ensuring vaccine accessibility and affordability in developing countries was a goal of Chinese diplomacy.
It should be noted that China is still on the lower echelon of the international hierarchy of the vaccine industry, which has developers and manufacturers in GAVI at the top. Chinese practices of inoculation and vaccination have hundreds of years of recorded history. But it was not until 2013 that China had a Chinese-made vaccine (for a strain of encephalitis) prequalified by the WHO. It was nonetheless the official beginning of the Chinese vaccine industry entering the world market as a supplier and licenser (WHO 2014). This achievement was possible after decades of collaboration with PATH (Programs for Appropriate Technology in Health), a coalition of medical and business interests headquartered in Seattle, Washington. PATH in turn works in close collaboration with GAVI (Stevenson 2018).
China’s pledge to make its vaccines a public good for global health also results from necessity in vaccine development. The country’s swiftness in bringing the pandemic under control left it short of infected patients to carry out Phase III trials. As a result, Chinese candidate vaccines are being tested in over a dozen developing countries, including populous ones like Brazil and Indonesia. When Chinese COVID-19 vaccines successfully acquire prequalification status from the WHO, they will be eligible for inclusion in the COVAX Facility for distribution including among countries that have not participated in the test trial stage of development.
In addition, China can and indeed should play a more active role in the Developing Countries Vaccine Manufacturers Network (DCVMN). For example, through this platform, China could license the production of its vaccines in other developing countries and make available its own manufacturing capacities to mass-produce vaccines developed abroad under proper licensing. As a mechanism, the DCVMN can make up for relative weakness in development by facilitating massive levels of manufacturing to meet the presumed high demand. A speedy transition from a proven vaccine to large-scale manufacturing will be essential in order to commence immunization globally as soon as possible. The right mixture would also require time, prequalification by the WHO, and certification by national regulatory authorities. In any case, fuller utilization of the world’s vaccine manufacturing capacity is conducive to the goal of reducing per-unit costs and thus enhancing their accessibility for low and lower-income countries.
Hopefully, China’s proactiveness toward COVID-19 vaccines becomes a new normal in its approach to international health affairs. Overall, for the sake of managing COVID-19 and international health security in general, at the very least, when a country as populous as China moves more firmly in the direction of materially ameliorating a global health emergency, stress on the entire world can be reduced. In terms of global health governance, this is more affirmation that expertise-based international cooperation rather than competition for international political status is what truly matters.