Vaccine manufacturing is a rate-limiting step as nations prepare for the next, as-yet-unknown, pandemic. A global network of “warm” facilities able to quickly transition from their current products to the relevant vaccines is the go-to solution. However, setting that up is easier said than done.
Implementing a network of ready-to-go facilities on a global scale requires two things: international government, non-governmental organization, and industry collaboration; and optimized manufacturing processes to “capitalize on the modularity offered by vaccine platform technologies,” according to the soon-to-be-released book, Principles and Practice of Emergency Research Response (Springer, October 2, 2024).
Focusing on manufacturing, chapter authors Richard Hatchett, MD, CEO, and Nicole Lurie, MD, U.S. director, both with the Coalition for Epidemic Preparedness Innovations (CEPI), and Aishani Aatresh, former CEPI intern, currently a biological systems engineer at Centivax, cite the inequitable distribution of COVID-19 vaccines as a key concern. In 2023, for example, 17 of the 43 nations with the capacity to manufacture vaccines were located in Europe.
To prevent vaccine inequity from recurring in some future pandemic,the book authors highlight the need to manufacture vaccines in low- and middle-income countries as well as in the developed world.
A recent paper by Suneth Agampodi, MD, of the International Vaccine Institute (IVI) and colleagues at IVI and Yale University also called for “strategically allocating biomedical manufacturing facilities,” to better balance manufacturing capacity to global needs.
An earlier proposal by scientists at Georgetown University and Johns Hopkins University suggested one way in which that may be done: locating vaccine manufacturing facilities in small countries that could quickly fulfill their own needs and then begin to supply the rest of the world.
Collaboration critical
However it occurs, the goal is to produce investigational doses within the first 100 days, and to manufacture quantities for large populations during the second 100 days. One challenge will be the plethora of vaccine platforms involved. Vaccines against SARS-CoV-2, for example, used 11 different platforms, according to the World Health Organization’s COVID-19 vaccine tracker.
Differences between expertise and infrastructure vary among regions. Therefore, significant process optimization is needed before such a global network is truly feasible to confront the next pandemic. CEPI’s list of requirements includes temperature stability for advanced vaccines, as well as a more extensive cold chain to extend delivery to resource-poor communities. Whether these goals can be achieved depends partially upon the strength of collaborations among stakeholders.
Going it alone, Moderna paused its efforts to build an mRNA manufacturing facility in Kenya last spring, citing lack of demand and some $1 billion in losses and write-downs. A few weeks later, the BioNTech/CEPI partnership expanded efforts to build a facility in Rwanda to manufacture mRNA vaccines from R&D through commercial-scale quantities.
Whether lessons from the COVID-19 pandemic or subsequent outbreaks of avian flu and mPox will be implemented in time for the next pandemic remains to be seen.
But a portion of the global community, at least, is thinking about it.
