The recommendations were made in a closed session with representatives from CBER, the CDC and Department of Defense.
The FDA on Thursday released the list of virus strains to be included in influenza vaccines for the upcoming 2025-2026 flu season.
These strain recommendations were made in a closed, interagency meeting with several representatives from the agency’s Center for Biologics Evaluation (CBER) and Research and the Centers for Disease Control and Prevention (CDC), as well as one attendee from the Department of Defense. The government experts backed the use of trivalent shots for an H1N1, an H3N2, and a Victoria-lineage subtype, using standard industrial production, as per a brief meeting summary.
Traditionally, strain recommendations are voted on by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), a panel of external experts that the agency convenes periodically to review the literature on vaccines and make non-binding recommendations to the regulator. Members of the VRBPAC are what the agency calls “science-oriented professionals” and are outside experts in their respective fields. Panelists typically include statisticians, public health experts, physicians and researchers.
Late last month, however, news broke that the FDA had cancelled without explanation the VRBPAC meeting where panelists were scheduled to vote on the flu vaccine strains. The Committee was originally scheduled to convene on Thursday. A separate subcommittee meeting had also been cancelled, a VRBPAC member told Reuters at the time.
The regulator has forwarded these recommendations to companies that manufacture FDA-approved flu vaccines. The agency expects supply to be “adequate and diverse” for the coming season, according to the meeting summary. Influenza, a vaccine-preventable but highly transmissible respiratory condition, last month hit its highest level in the U.S. since 2015, according to CDC data. Rates have since gone down but remain “elevated nationally,” as per the agency.
In his confirmation hearing last week, Marty Makary, whose nomination for FDA commissioner is up for full Senate vote soon, showed lukewarm support for the VRBPAC. Makary promised that under his leadership, the vaccine advisors would be able to continue convening, though he did not commit specifically to rescheduling the canceled meeting.
Makary also noted that he would “re-evaluate which topics deserve a convening of” the VRBPAC, “and which may not require a convening.”
Vaccine advisors for the CDC also had their meeting postponed last month. The experts were supposed to discuss immunization recommendations for various infectious diseases, including influenza. Also on their agenda were new vaccine formulations, including Moderna’s mRNA COVID-19 vaccine and GSK’s meningococcal shot Penmenvy.
These high-level meeting disruptions follow the confirmation of vaccine critic Robert F. Kennedy Jr. as Secretary of Health and Human Services.
