The Food and Drug Administration’s (FDA) upcoming Vaccine and Related Biological Products Advisory Committee meeting on March 13 was abruptly canceled via email on Wednesday. The committee was to consider the selection of strains to be included in the influenza virus vaccines for the 2025–2026 flu season. This is the second vaccine-related advisory meeting canceled since Robert F. Kennedy, Jr. took over at the Department of Health and Human Services (HHS).
No reason for the cancellation was given, and the committee members were warned against forwarding the email. It suggested that members decline to answer questions from media.
So much for Kennedy’s pledge earlier this month of “radical transparency.” He added, “We will make our data and our policy process so transparent that people won’t even have to file a FOIA [Freedom of Information Act] request.”
In addition to suggesting members of the FDA’s vaccine committee stifle themselves, the HHS will publish a notice next week in the Federal Register to eliminate public comment on that agency’s plans and decisions. While past meetings have been open to public scrutiny and participation, it is not clear if the new limits will apply to future meetings of the committee. Radical transparency, indeed.
With respect to the normal processes for evaluating and developing annual flu vaccines, the FDA has previously explained:
The job of producing a new vaccine for the next flu season starts well before the current season ends. For the FDA, it’s a year-round initiative.
Flu viruses are constantly evolving. The flu viruses that circulate and cause disease in people often change from one year to another, necessitating a new vaccine every year.
To accomplish this, the FDA, World Health Organization, the Centers for Disease Control and Prevention and other partners collaborate by collecting and reviewing data on the circulating flu strains from around the world to identify those likely to cause the most illness in the upcoming season.
In late February/early March — well before the new influenza season begins, the FDA convenes its vaccines advisory committee to review data about which flu viruses have caused disease in the past year, how the viruses are changing, and disease trends so they can recommend the flu virus strains to include in the vaccines for the upcoming U.S. flu season.
Once the strains are selected, vaccine manufacturers begin the manufacturing process to include the newly selected flu strains in their FDA-approved vaccines. The different virus strains are combined to formulate the vaccine into standard dosages. The vaccine is then filled into vials, syringes and, for the nasal vaccine, sprayers.
Flu vaccine effectiveness varies from year to year depending, among other things, on whether the FDA guessed right about which strains will be circulating each season. The current vaccine is around 40 percent to 60 percent effective against influenza-associated hospitalization.
Noting that the U.S. is currently experiencing one of the worst flu seasons in a decade, Infectious Diseases Society of America president Tina Tan warns that “cancelling a critically important Food and Drug Administration meeting that is vital to the development of effective flu vaccines for next flu season is irresponsible.” She adds, “Cancelling this meeting means vaccine makers may not have the vital information and time they need to produce and distribute targeted vaccines before the next flu season. If the FDA meeting is not immediately rescheduled, many lives that could be saved by vaccination will be lost.”
RFK, Jr.’s HHS promises that the FDA “will make public its recommendations to manufacturers in time for updated vaccines to be available for the 2025-2026 influenza season.”
We’ll see.
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