The Food and Drug Administration (FDA) will require more evidence for what top officials describe as the uniquely American “repeat-boosters-in-perpetuity strategy,” the recommendation that even healthy adults receive a yearly COVID shot.
FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled the new policy in the New England Journal of Medicine (NEJM) Tuesday. The policy marks a departure from a policy initiated under the Biden administration to universally recommend a yearly COVID-19 booster akin to an annual flu shot.
“I think we have to admit to ourselves that America is deeply divided on the policy of repeated COVID-19 vaccines or boosters,” Prasad said at an FDA town hall. “There are some Americans who are worried that the FDA has not fully documented and interrogated the safety harms of these products and they are categorically opposed to these products. There are also some Americans, we also have to recognize, who are desperate for additional protection and demand the product.”
Most Americans are uncertain about boosters, as middling uptake of yearly boosters demonstrate, Prasad argued. The new guidelines would align the U.S. more closely with other high-income countries around the world, according to the new framework.
Australia, Belgium, Canada, Denmark, Finland, France, Germany, The Netherlands, Sweden, Switzerland and the United Kingdom largely recommend booster shots for populations 60 years old or older and for people with underlying conditions.
“The truth is that for many Americans we simply do not know the answer to whether or not they should be getting the seventh or eighth or ninth or tenth COVID-19 booster as current policy would have us go down the road of,” Prasad said.
The FDA thus must collect more evidence, he said.
The FDA is likely to approve annual booster shots in people 65 years old or older. The officials also anticipate the benefits will outweigh the risks for adults and children older than 6 months with one or more health conditions that give them a higher chance of severe COVID. The officials signaled the FDA is likely to approve yearly boosters for these populations without new clinical trials, which take months and could limit their uptake. FDA could approve booster shots for high-risk populations based on immunogenicity data, or antibody levels.
The Centers for Disease Control and Prevention list of risk factors for severe COVID are broad, the NEJM article shows, including asthma, obesity and mental health conditions like depression. Thus roughly 100 million to 200 million Americans will still be able to get a booster shot if they want one under the new plan.
But for the millions of healthy Americans under the age of 65, the FDA will require more randomized controlled clinical trials, the officials write.
A new article from the @US_FDA compares broad U.S. recommendations on Covid vaccination with those from other countries and announces the adoption of an evidence-based approach to such recommendations.
Read the full article: https://t.co/VTCFE8A4Gk #IDThreads pic.twitter.com/FtFsDLPD6g
— NEJM (@NEJM) May 20, 2025
FDA seeks a stronger evidence base on booster recommendations for the 50 to 64 year-old age group in post-marketing trials by companies like Moderna and Pfizer, according to the framework. The clinical trials should track symptomatic COVID infections, with severe COVID-19, hospitalization, and death as secondary endpoints.
The clinical trials should track reinfections for six months of follow-up, the framework says. And drugmakers should include individuals who have immunity from a prior infection to mimic real-world circumstances.
The officials also say the new framework “does not preclude” other randomized trials in healthy populations younger than 50.
Recommending boosters for high-risk individuals rather than a universal approach would bring the U.S. in alignment with the rest of the world, said Monica Gandhi, a professor of medicine at the University of California, San Francisco, to the Daily Caller News Foundation. She added that recommendations had been muddled in part due to fear-based messaging by some public health officials.
“I think that we should be consistent with the [World Health Organization] and Canada and the UK and Australia and other high-income countries in using a risk-based vaccination strategy,” Gandhi told the DCNF ahead of the new guidelines being unveiled. “Public health has always been a risk-based field.”
An earlier 2022 British Medical Journal study coauthored by Makary and Prasad concluded that the adverse events and social costs of vaccination in college students mandated to receive a COVID-19 vaccine outweighed the benefits.
The announcement comes just days before a Thursday meeting of the outside scientists who advise FDA on vaccines is set to vote on recommendations on the selection of strain of COVID-19 vaccines.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in a session open to the public for several hours.
The FDA briefing materials for that meeting, published Tuesday, acknowledge that as the coronavirus has evolved the efficacy of the vaccines has declined.
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