The FDA will convene its vaccines advisory panel to discuss seasonal COVID-19 vaccines—a surprise move after Health Secretary and vaccine skeptic Robert F. Kennedy, Jr. overhauled a separate vaccine committee.
The FDA will convene its Vaccines and Related Biological Products Advisory Committee to discuss possibly updating COVID-19 vaccines to include the now-dominant XFG subvariant. The meeting will take place on Thursday, May 28.
The session will be a whole-day affair, during which the external experts will hear from the CDC and an independent working group from the World Health Organization, according to a draft agenda posted on the FDA’s website. The U.S. withdrew from the WHO in January.
Vaccine developers Moderna, Sanofi and Pfizer will also be at the meeting to present updates from their respective products, per the federal documents.
The FDA’s VRBPAC has convened several times over the years—once during the second Trump administration—to evaluate strain selection and vaccine formulation. During its May 2025 meeting, the vaccines advisory committee unanimously voted to recommend monovalent COVID-19 vaccines targeting the JN.1 lineage of the virus, according to a briefing document posted Tuesday.
But the latest data from the CDC show that the XFG subvariant has now become the dominant type of virus circulating in the U.S. “More than six years after its emergence, SARS-CoV-2 is evolving against an increasingly heterogeneous immune landscape,” the FDA’s briefing document reads, pointing to varying levels of virus exposure, vaccination adherence and waning immunity across the country.
The VRBPAC will be tasked with making a recommendation for a COVID-19 vaccine formulation against this backdrop, the FDA said. “All licensed manufacturers have indicated that they are prepared to produce an XFG vaccine for COVID-19 vaccines,” the agency added.
The COVID-centric meeting comes shortly after the resignation of former FDA Commissioner Marty Makary—a known critic of COVID-19 vaccines. In his first public interview as FDA chief in April 2025, he claimed that the agency downplayed the side effects of COVID-19 shots, leading to what he called the “epidemic of distrust” against the regulator.
A month later, he unwrapped a risk-based approach to approving COVID-19 vaccines, noting that moving forward, the regulator would focus on products for adults 65 and older and high-risk patients with underlying conditions. Makary penned this new risk-based framework with Vinay Prasad, former director of the Center for Biologics Evaluation and Research, and a similarly vocal critic of COVID-19 vaccines.
Late last year, Prasad wrote an internal memo—that was subsequently leaked—claiming that “at least” 10 children have died “because” of COVID-19 vaccines. “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children,” he wrote at the time. Detailed data from the agency have since shown that Prasad’s claims were overblown, and that no pediatric deaths have been definitively linked to the shots.
Prasad left the FDA at the end of April.
Health Secretary Robert F. Kennedy, Jr. is himself a major skeptic of vaccines. Last May, for instance, Kennedy removed COVID-19 shots from the regular immunization guidelines for healthy pregnant women and healthy children. A few weeks later, he emptied the CDC’s vaccines advisory panel in a move he said at the time was “necessary to reestablish public confidence in vaccine science.”
He has since reformed this group, called the Advisory Committee on Immunization Practices, filling it with experts who share his skepticism toward vaccines.
