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Complexity of Vaccine Manufacture and Supply

  • Philippe JuvinEmail author
Chapter
Part of the Practical Issues in Geriatrics book series (PIG)

Abstract

There is a shortage of medicines and vaccines on a global scale in the world today. Yet, ensuring a continuous supply of high-quality, safe, effective and affordable medicines is a fundamental component of a good health system, and shortages in medication supply can jeopardize equal access for all to enjoy the highest possible standard of health. The production of drugs and vaccines is a complex journey within a highly regulated industry, and changes or incidents anywhere along the production pathway may affect production capacity and supply chains down the line. The production of vaccines of consistently high quality requires specialized equipment, long and complex manufacturing cycles, in an increasingly regulated environment that meets stringent quality standards that may differ between countries. In view of this lengthy and complex process, it can be difficult to establish exact inventories of vaccine stocks, thus making it hard to anticipate potential shortages. In addition, in times of increased demand for vaccines, manufacturing and supply pathways may not be able to keep pace with the sudden spike in demand. The pharmaceutical industry is making a concerted effort to improve vaccine availability, in concertation with other major stakeholders, such as governments, wholesalers, regulators and the pharmacy profession. A platform for open and continuous dialogue between public health institutions and industry is warranted to discuss strategies for decreasing the complexity of vaccine production and release, as well as reducing the regulatory burden. All stakeholders must seek common solutions for improved vaccine supply, have better anticipation of vaccine needs, encourage innovation and ultimately improve vaccine availability.

Keywords

Vaccine Manufacturing Supply Regulatory procedures Pharmaceutical industry 

References

  1. 1.
    Gatesman ML, Smith TJ. The shortage of essential chemotherapy drugs in the United States. N Engl J Med. 2011;365(18):1653–5.CrossRefGoogle Scholar
  2. 2.
    Chabner BA. Drug shortages—a critical challenge for the generic-drug market. N Engl J Med. 2011;365(23):2147–9.CrossRefGoogle Scholar
  3. 3.
    Jensen V, Rappaport BA. The reality of drug shortages—the case of the injectable agent propofol. N Engl J Med. 2010;363(9):806–7.CrossRefGoogle Scholar
  4. 4.
    Mirtallo JM. The drug shortage crisis. JPEN J Parenter Enteral Nutr. 2011;35(4):433.CrossRefGoogle Scholar
  5. 5.
    Sixty-ninth World Health Assembly. Addressing the global shortage of medicines and vaccines. WHA69.25. 2016. http://apps.who.int/medicinedocs/documents/s22423en/s22423en.pdf. Accessed 23 June 2018.
  6. 6.
    Waning B, Diedrichsen E, Jambert E, Barnighausen T, Li Y, Pouw M, et al. The global pediatric antiretroviral market: analyses of product availability and utilization reveal challenges for development of pediatric formulations and HIV/AIDS treatment in children. BMC Pediatr. 2010;10:74.CrossRefGoogle Scholar
  7. 7.
    International Federation of Pharmaceutical Manufacturers & Associations. The complex journey of a vaccine. The manufacturing chain, regulatory requirements and vaccine availability. 2016. https://www.ifpma.org/wp-content/uploads/2016/01/TheComplexJourneyofaVaccinePRINT-EN.pdf. Accessed 23 June 2018.
  8. 8.
    Fineberg HV. Pandemic preparedness and response—lessons from the H1N1 influenza of 2009. N Engl J Med. 2014;370(14):1335–42.CrossRefGoogle Scholar
  9. 9.
    World Health Organization. Vaccination in humanitarian emergencies: implementation guide. Geneva. Licence: CC BY-NC-SA 3.0 IGO. 2017. http://www.who.int/immunization/documents/general/who_ivb_17.13/en/. Accessed 23 June 2018.

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Sanofi PasteurLyonFrance

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