The remarkable news of record-breaking COVID-19 vaccine development has been clouded by the increasing emergence of new variants of the SARS-CoV-2 virus. Like other viruses, SARS-CoV-2 mutates over time, due to random errors in copying its genetic sequence. When one of these mutations helps the virus survive and reproduce—such as by making the virus more transmissible—that variant will spread more rapidly than the original virus through natural selection. The global effort to control the pandemic has thus been framed as a race between the vaccines and the variants: can the world be vaccinated before the virus evolves to evade the vaccines? In this post, we examine how COVID-19 vaccine developers are responding to the spread of variants, how the FDA plans to regulate updates to the vaccines, and other innovation policies governments should consider to combat the variant spread.
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Once variants exist, it is important to know what, where, and how widespread they are. This means genetic surveillance—sequencing infected patients to know which variant they have contracted. Genetic surveillance is a problem of nonexcludable innovation, which suggests that private actors are unlikely to spend enough on it, leaving governments to fill the gap. Some governments do genetic surveillance very well; the United States doesn’t, at least nationally. Such surveillance should also help scientists understand how effective existing vaccines are in managing the spread of variants.
Better understanding the performance of vaccines suggests its own potential policy intervention. Each vaccine was tested in a different time frame, with different populations, in different places, and—crucially—with different variants at different levels circulating in the population. As a result, despite headlines trumpeting different vaccine performances (and some policy reactions), no one really knows whether Johnson & Johnson’s or AstraZeneca’s vaccines are actually less effective than Moderna’s and Pfizer–BioNTech’s. Even less is known about how a vaccine modified to address a variant would compare with any of them. Running comparative randomized controlled trials between multiple different vaccines seems unlikely—indeed, comparative trials are underfunded generally—but at the very least policymakers should consider robust systems for collecting observational data to understand how different vaccines perform.
Once vaccines are approved, getting them made remains a challenge—and with variant vaccines, that challenge will continue. Flexible manufacturing platforms should make it easier to get variant vaccines into scaled-up production more rapidly, and further investment in such platforms could help with that challenge. As we’ve noted, older processes to manufacture vaccines were materials intensive—some involve incubating viruses in chicken eggs. mRNA vaccines, on the other hand, are less resource intensive and seem especially well suited to variants, since the encapsulated mRNA sequence can be easily altered without changing other production parameters. Government efforts to improve manufacturing generally, and especially around mRNA or other flexible manufacturing platforms, could be essential to producing variant vaccines if COVID becomes endemic and continues to change.
Finally, getting vaccines into arms is always the last step, without which nothing matters; investing in better vaccine roll-out is essential if variant boosters will become routine. An example for this exists, of course: the annual flu vaccine. Someday we all may get annual COVID vaccines, tailored to that year’s new variants. But for that to work, the health system would need to do a better job keeping track of who gets what, whether first and second vaccine shots can be mixed and matched, and how to insure that ongoing distribution is efficient, affordable, and equitable.