FDA Prioritizes COVID Vaccine for 65+ and High Risk

The FDA will prioritize approval of COVID-19 vaccines which can be proven to generate antibody titers in people over age 65 or people who are 6 months or older and at high risk for severe disease, the agency announced on Tuesday.

The focus on these age groups will bring the US in line with European nations, Canada, and Australia, many of whom recommend boosters only in those age 60 or older or who are otherwise at high risk, said FDA Commissioner Martin Makary, MD, and Vinay Prasad, MD, the new chief of the FDA’s Center for Biologics Evaluation and Research. They explained the new regulatory priorities in a May 20 New England Journal of Medicine paper. 

The FDA announcement comes just 2 days before the FDA’s Vaccines and Related Biologics Products Advisory Committee will meet to discuss which strains should be included in this fall’s COVID booster.

“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,” said Prasad, at a “town hall” explaining the new policy. The event was held at the FDA’s headquarters and livestreamed. 

Even though the risk of severe disease and hospitalization have declined, “the efficacy of repeat doses…to further reduce severe disease and symptomatic illness is uncertain and there are important safety considerations whose long-term impact is not fully known,” he said. 

Prasad said the agency’s new stance meant that the vaccine would be approved for about a third of the US population. “This effectively means 100 to 200 million Americans, those with the most favorable benefit-to-harm balance, will be covered by such approvals,” he said.

Based on existing evidence of antibody titers from previous studies, the COVID vaccines would be approved for anyone over 65, and people over 6 months who have conditions such as cancer, diabetes, kidney disease, HIV, physical inactivity, obesity, and who are current or former smokers, among many others.

This is a departure from current recommendations from the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), which for the winter of 2024-25, urged all Americans over 6 months of age to get a booster and that people who are immunocompromised receive two boosters. 

ACIP will meet in late June to discuss its recommendations on who should receive the COVID shots in the fall.

Prasad said the FDA will start requiring manufacturers to conduct randomized, controlled trials to prove that the COVID-19 vaccines protect against symptomatic COVID and severe consequences in healthy individuals aged 50-64.

For other age groups or specific populations, manufacturers “are, of course, free to conduct their own randomized studies,” said Prasad. 

Both Makary and Prasad said the agency was striking a balance between regulatory flexibility “and a commitment to gold-standard science,” noting that it would approve vaccines for people at high risk of COVID and demand data for those at low risk.

It was time to take a new approach, said Prasad. “The virus has changed,” he said. “Many Americans have been infected multiple times, the risk of severe disease is lower. This is not June of 2020. This is 2025, so our policies at FDA, the standards for evidence have to also shift,” he said.

Makary agreed. The original COVID vaccine trials “are now four and five years old,” he said, at the town hall. Makary said the “virus is much different,” and that “there is now broad population immunity.”

The Commissioner said the FDA was “not going to be removing vaccines from the market,” but would be asking for additional data on low-risk populations.

In a post on X, Peter Hotez, MD, professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, Houston, said that the FDA’s policy doesn’t seem to “consider the benefits of vaccinating vs long COVID,” and that there was “no clarity who determines risk factors such as ‘physical inactivity’.” And on choosing whether a healthy individual wants to be vaccinated, “now the decision is no longer between you and your doctor,” he wrote.

Others have been calling for a better framework for COVID vaccination. “A 6-month-old does not need an annual COVID-19 booster; my 90-year-old father does,” Monica Gandhi, MD, an infectious diseases specialist and professor of medicine at University of California, San Francisco, posted on X in April. 

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.