The U.S. Food and Drug Administration (FDA) is changing the game on COVID-19 vaccines. Instead of approving yearly boosters for everyone, the agency is now focusing on high-risk individuals and requiring more rigorous testing for new vaccines. It’s a major shift that puts science — not the calendar — at the center of future vaccine decisions.
This new approach was laid out in a commentary published Tuesday in the New England Journal of Medicine by FDA Commissioner Dr. Marty Makary and the agency’s new vaccine policy director, Dr. Vinay Prasad. They argue that moving forward, COVID vaccines must go through placebo-controlled clinical trials — the kind where some people get the vaccine and others get a placebo — before receiving full approval for broad use.
This means vaccine makers like Pfizer and Moderna will no longer be able to rely on small studies to push updates to market for everyone. Instead, they’ll have to show clear evidence that their vaccines reduce symptoms in real-world conditions — with at least 30% effectiveness, tracked over six months.
Fewer Shots, Fewer People
One of the biggest takeaways? Annual COVID shots for healthy children and adults will no longer be the norm. Dr. Prasad was clear: “The virus doesn’t have a calendar,” he said during a Q&A session. “We should let science guide us, not the calendar year.”
While those at high risk — including older adults, pregnant women, and individuals with conditions like obesity, heart disease, diabetes, and mental health disorders — will still have access to updated shots under streamlined testing, healthy individuals may face delays in getting the latest vaccines.
That’s because the new rules require more time-consuming clinical trials for broader populations. Vaccine makers must design the studies, enroll participants, collect and analyze data, and then submit findings for FDA review — a process that can take months. It’s unlikely this will happen in time for the 2025 fall season for healthy people.
Criticism and Concerns from the Medical Community
Not everyone is on board with the FDA’s new direction. Dr. Jesse Goodman, former FDA chief scientist and now a professor at Georgetown University, expressed concern that the changes might restrict vaccine access for people who still want protection — even if they’re not classified as high-risk.
“What about people who live with elderly or immunocompromised relatives?” he asked. “What about people who just don’t want to get sick or miss work?”
Dr. Paul Offit, a member of the FDA’s vaccine advisory panel, warned that just because someone is “low risk” doesn’t mean they’re immune. “Anybody can be hospitalized or die from this virus,” he said.
Even more controversially, critics say the FDA has overstepped its usual role. Typically, the Centers for Disease Control and Prevention (CDC) — specifically its Advisory Committee on Immunization Practices — determines who should get vaccinated. Goodman questioned why the FDA made such sweeping recommendations on its own without the CDC’s usual public advisory process.
HHS Secretary Kennedy’s Influence Raises Eyebrows
The shift also comes amid growing influence from Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic. Earlier this month, Kennedy ordered that all new vaccines must undergo placebo-controlled trials, raising questions about how updated COVID shots would be classified.
Kennedy’s history includes filing a 2021 petition urging the FDA to revoke emergency authorization for COVID vaccines and falsely labeling them “the deadliest vaccine ever made.” Public health experts have since debunked those claims, noting that severe complications, such as myocarditis, are much more likely after a COVID infection than from the vaccine.
At a recent Senate hearing, Kennedy also incorrectly claimed that the COVID vaccines were the only ones tested against a placebo — prompting a correction from Senator Bill Cassidy, a physician, who pointed out that vaccines for rotavirus, measles, and HPV have all been tested the same way.
What This Means for Fall 2025 and Beyond
The FDA estimates that between 100 million and 200 million Americans will still be eligible for updated vaccines this fall — primarily those in high-risk categories. A key advisory meeting is scheduled for Thursday to decide which strains the next round of shots should target.
Meanwhile, the FDA’s recent decision to limit Novavax’s COVID vaccine to older adults and those with underlying health issues suggests a broader trend: fewer approvals, more caution, and a tighter focus on people most vulnerable to serious illness.
This is a far cry from the early pandemic days, when mass vaccination was encouraged for nearly everyone. Now, the FDA says the science — not sweeping one-size-fits-all mandates — should drive decisions.
