The independent experts will meet on May 22 to discuss updates to the COVID-19 vaccine for the upcoming season.
Later this month, the FDA will convene its external vaccine advisors to decide on the formulation for COVID-19 vaccines to be used in the upcoming 2025-2026 season, according to a Federal Register notice posted Thursday. The meeting is scheduled for May 22.
Importantly, Federal Register notices should go live at least 15 days before the scheduled meeting. In this case, the announcement should have been posted on Wednesday, May 7. “FDA regrets that it was unable to publish this notice 15 days prior to the [meeting] due to technical issues,” the notice reads.
Still, the agency decided to push through with the panel, noting the “need for an immediate meeting of the Committee, including the time-sensitive need for input and public discussion” on the subject at hand. The FDA “concluded that there are exceptional circumstances that support holding this meeting without the customary 15-day public notice.”
This urgency is a notable change in tone for the current administration, which in recent weeks has expressed strong skepticism of the COVID-19 vaccines. In February, Health and Human Services Secretary Robert F. Kennedy Jr. postponed a meeting of the Centers for Disease Control and Prevention’s vaccine advisors. The panelists were supposed to have met on Feb. 27 to update immunization recommendations for a host of infectious diseases, including COVID-19.
Kennedy’s HHS has also frozen its support for drugmakers developing next-generation COVID-19 vaccines, including GeoVax and Vaxart (the latter of which has had its stop order lifted). And last month, the FDA missed its decision date for Novavax’s updated COVID-19 vaccine. Later, the company revealed that the FDA is asking for a post-marketing commitment to collect additional clinical data for the shot.
Late last month, Politico reported that Kennedy was considering pulling COVID-19 vaccination from the CDC’s immunization guidelines for children—a move that would put the U.S. in line with international standards, but would also show how comfortable the secretary is in “making unilateral decisions,” BMO Capital Markets said in an investor note at the time.
Most recently, HHS named Vinay Prasad as the new head of the FDA’s Center for Biologics Evaluation and Research—succeeding Peter Marks, who was a staunch supporter of vaccines during his term.
Prasad, an oncologist and hematologist at the University of California, San Francisco, has built a name for himself on YouTube as an outspoken critic of some public health policies. Most notably, Prasad came out strongly against university COVID-19 vaccine mandates and argued on his YouTube channel that the disease has become merely a “common cold respiratory virus.”