On May 20, the U.S. Food and Drug Administration (FDA) released a new plan going forward with COVID-19 vaccine boosters. This announcement made big waves — even as far as the New England Journal of Medicine. This new policy represents a sea change in the world of vaccine availability, especially among underserved demographic populations. The FDA has recently revised its guidelines. Now, they will only approve new and updated vaccines for those 65 years and older, and for those six months to 64 years with at least one medical condition that increases the individual’s risk of severe outcomes from COVID-19.
The FDA’s announcement coincides with health experts’ divided sentiments over the need and effectiveness of these boosters. Susan Ellenberg, a prominent figure in vaccine monitoring, emphasized that while she supports the new framework, she has concerns about limiting access. She didn’t just express her concern. I don’t like the idea of limiting those things so anybody outside that specific category of people wouldn’t be able to get it if they wanted to.
This new requirement would affect 100 million to 200 million Americans. Chief among them, of course, is the public health nightmare that continues to be caused by SARS-CoV-2, the virus that causes COVID-19. Annually in the US, the virus still leads to around 300,000 hospitalizations and around 30,000 deaths.
Vaccine candidates need to show that they reduce disease in the vaccinated population by at least 30 percent versus a placebo population. This is required in order to receive FDA approval under the new framework. The FDA plans to require randomized controlled trials testing these products against a saline placebo in individuals aged 50 to 64 once a vaccine is licensed.
There is cause for alarm about the impact of such strict testing requirements on vaccine availability. Ellenberg pointed out the likely unacceptable delays in being able to do placebo-controlled trials. This is particularly important for those 50–64, who stand to benefit the most from the most recently updated vaccines.
And this shift is reflected in the evolving nature of booster campaigns, as noted by Vinay Prasad, yet another powerful contrarian voice in this field. We’ve now set off on this multiyear campaign of booster after booster after booster,” he added. Prasad warned that we don’t have enough data yet to know the long-term effects of repeated COVID-19 vaccine doses. That worry amplifies as people are just starting to get their seventh, eighth and ninth doses.
The FDA’s revised guidelines are an indicator of a larger change in how the agency will define vaccine efficacy. It will stop depending on stand-ins for safety, like immunity through antibodies. Rather, the FDA aims for robust evidence showing that vaccines substantially decrease the occurrence of symptomatic COVID-19.
As the new framework is implemented, insurance coverage for COVID-19 vaccine boosters will likely change as well. People who can no longer meet the expanded standards might incur out-of-pocket expenses, calculated at an average of $130 per shot. This new financial burden would make access to vaccines even more difficult in a time where we still face many pandemic-related challenges.
Given that the Pfizer-BioNTech and Moderna vaccines are mRNA vaccines, they might face these new restrictions as well now. We know that both vaccines are excellent at preventing severe COVID-19 illness. Their continued use in the future will depend on whether they can clear the new rigorous standard of evidence demanded by the FDA.
Prasad raised a critical point about public health messaging and vaccine strategy. We’re hoping to gain a better understanding of the impact of these products. This is most critically important as we start the seventh, eighth, and now ninth doses. He further remarked on the implications of the current framework for average-risk and low-risk Americans: “We do not have gold-standard science to support this for average-risk [and] low-risk Americans.”
Paul Offit, one of the country’s leading vaccine researchers, long ago admonished us to face an inconvenient truth. There is no risk-free cohort, as it relates to COVID, Goodman said. He added, “There is no no-risk group.… There is an assumption that anybody can’t be seriously infected by this virus.” This announcement highlights the need for sustained vaccination investments for all ages and communities.
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