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Title:

Building the global vaccine manufacturing capacity needed to respond to pandemics

Authors:
Tara Kirk Sell, Daniel Gastfriend, Matthew Watson, Crystal Watson, Lauren Richardson, Anita Cicero, Tom Inglesby, Nancy Connell
Date posted:
February 24, 2021
Publication type:
Article
Publication:
Vaccine
DOI:
https://doi.org/10.1016/j.vaccine.2021.02.017
Availability:
Available on publisher's website
See also:
Introduction:

Among the most pressing issues in preparing for the global response to a pandemic are the design, development, manufacture, and dissemination of vaccines. In 2018 and 2019, we conducted 48 interviews with prominent leaders in public health, pandemic preparedness, vaccine design, and vaccine manufacturing about how they would respond to a sudden, urgent need to manufacture 2 billion or more doses of vaccine. Little did we know that this scenario would become a dire global challenge a few months later with the onset of COVID-19. The response to this pandemic has shown that when leading vaccine manufacturers are fully engaged in a global response, it might be possible for them to manufacture substantial doses of vaccine on timelines faster than previously envisioned. It is now hoped that hundreds of millions of doses of vaccine will start to be produced sometime in the end of 2020 or the start of 2021, and that billions of doses of vaccine could be produced in the months that follow. Whether these timelines can be met or not, it is crucial now, while the world is fully attuned to the terrible consequences of pandemics, to begin preparing the system of global manufacturing for future pandemics. The following insights and recommendations are taken from our interviews with leading experts and our own analysis.

Vaccine manufacturers are best prepared to confront an influenza pandemic, among known biological threats. The influenza vaccine is produced annually at scale through a consistent platform, allowing manufacturers to quickly ramp up production to billions of doses. As of 2015, high-income countries had the capacity to produce 1 billion seasonal influenza vaccine doses each year, while upper-middle income countries could produce 250 million doses and lower-middle income countries could produce 200 million doses. In the event of a pandemic, manufacturers could scale up production to 6.4 billion doses of pandemic influenza vaccine active pharmaceutical ingredient (API) within 12 months. Some experts we interviewed were skeptical that this number could be met in practice. Even if so, it would fail to meet the WHO Global Action Plan for Influenza Vaccine goals, which calls for 70% of the global population to receive two vaccines within six months.1, 2

Manufacturers are far less prepared to address novel threats. At the time of our study, most experts doubted that manufactures could scale up a novel vaccine on a timeline to adequately confront a catastrophic pandemic. Policymakers can adopt four approaches to expand vaccine supply in the event of a pandemic: stockpiling vaccines in advance of an outbreak; reserving excess manufacturing capacity for surge production; financing construction of new manufacturing capacity before or during an outbreak; and repurposing existing manufacturing facilities to produce a pandemic vaccine. Before COVID-19, experts believed these approaches could provide only a modest expansion of capacity within the first 12 months of a novel pandemic.

 

 

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