fda on boosters :: Article CreatorCOVID Boosters Might Not Be Updated For Next Season, FDA Commissioner Says
HealthDay News — The head of the U.S. Food and Drug Administration (FDA) reiterated Tuesday that the agency is applying a more skeptical approach to this year's round of COVID-19 vaccine boosters.
Companies applying for approval of COVID boosters are being encouraged to use "gold standard science," including full-fledged clinical trials involving healthy people, FDA Commissioner Dr. Marty Makary said today at the American Hospital Association's annual meeting in Washington, D.C.
That approach could mean no COVID boosters will be approved in time for next winter's respiratory disease season, Makary has warned in earlier interviews.
"We need some better data. We can't just extrapolate from a clinical trial from four or five years ago," he said at the conference. "Americans have a very low uptake and a very low confidence of the COVID boosters right now."
For example, 85% of health care workers did not get the last COVID booster, Makary noted.
"It's reasonable to say we'd like to see a clinical trial rather than just some antibodies that spike after you give [the vaccine]," he said. "You can make antibodies spike to anything. That doesn't tell us that it actually has a clinical benefit. Americans want to know, do we really, is there really a clinical benefit in healthy subjects?"
The FDA also is considering whether COVID boosters should be given primarily to high-risk groups, as opposed to general coverage, Makary added.
"Should we really be putting the full weight of the government to urge vaccination against COVID for a healthy, thin 12-year-old girl with her seventh COVID booster right now today in America?" Makary said. "I don't think so."
The commissioner also downplayed the impact that layoffs ordered by the Trump Administration might have on the FDA's effectiveness.
"There's a lot of people with impressive sounding titles, but that may not necessarily mean that they are working towards the core mission of the agency, which is to deliver more cures, diagnostics, therapeutics and healthy foods," Makary said. "We're committed to public safety, which was why none of the cuts that were made included scientific reviewers or inspectors."
The FDA has doubled its staff since 2007, Makary said, increasing from 9,500 employees to 19,000 employees just a few months ago.
Under the Trump Administration, there's been a 12% reduction in the workforce, Makary said, noting that's a lower level of staffing cuts than those ordered under President Bill Clinton for the U.S. Department of Health and Human Services.
"We need a lean FDA that's efficient, not a bloated FDA that is inefficient and slows down our approvals and inspections," Makary said.
More information
The U.S. Centers for Disease Control and Prevention has more on COVID-19 vaccines.
SOURCE: Presentation, American Hospital Association annual meeting, May 6, 2025
FDA Set To Meet This Month On COVID Vaccines
A panel of Food and Drug Adminsitration advisers will meet May 22 to discuss updating the formula of COVID-19 vaccines ahead of the fall and winter season, according to a draft notice posted Wednesday.
The Vaccines and Related Biological Products Advisory Committee will provide recommendations on selecting the specific coronavirus variant COVID vaccine manufacturers should target with booster shots. Their advice isn't binding, but the FDA tends to follow it.
The meeting will take place, however, as shakeups across the Department of Health and Human Services could raise new scrutiny on how boosters are developed and approved.
On Tuesday, the FDA announced the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research, which oversees vaccines as well as some genetic medicines and blood products. Prasad will be taking over Peter Marks' role, who resigned in March over differences with HHS Secretary Robert F. Kennedy Jr. On vaccines.
A critic of the FDA, Prasad has been skeptical of U.S. Policies and recommendations around COVID vaccines in the past. Leerink Partners analyst Mani Foroohar wrote in a Wednesday note that Prasad's stance significantly increases the "probability of a more restrictive COVID vaccine recommendation."
Advisers to the Centers for Disease Control and Prevention are separately contemplating a narrower, risk-based approach to COVID vaccine recommendations, which they will vote on at a June meeting.
Already, there are signs at the FDA of a shift in the agency's handling of COVID shots. A deadline for the FDA to approve Novavax's protein-based shot came and went last month without action. The company later said the FDA requested a postmarketing commitment to study the shot after an approval. It's not entirely clear what the agency has asked to do, but The Wall Street Journal reported it demanded an additional randomized controlled trial.
The FDA also appears to have shifted its approval requirements. A spokesperson for HHS confirmed to BioPharma Dive that all new vaccines must be tested in placebo-controlled trials prior to approval. In years past, updates to formulations for COVID vaccines have not been considered new products, much like how influenza shots are treated.
More recently, the FDA asked Moderna for more data on a combination flu and COVID shot it's developing before the agency would consider an approval, delaying the expected timeline. While Moderna said its interactions with the FDA have been business as usual, Foroohar described the FDA's action as evidence of a "higher bar" for vaccines.
COVID Boosters Might Not Be Updated For Next Season, FDA Commissioner Says
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