The recent cancellation of the FDA’s upcoming vaccine advisory committee meeting has sparked concerns about the U.S. flu vaccine supply for the next season. The meeting, which was scheduled for March 13, plays a crucial role in determining the flu strains for the upcoming flu shot. Experts fear the delay could cause a shortage of vaccines as drugmakers typically need timely guidance to produce enough doses for fall distribution.
Each year, vaccine manufacturers face a tight deadline to meet the demand for flu shots. While the federal government places preorders for vaccines in January and February, production can’t begin until the FDA selects the flu strains. Litjen Tan, co-chair of the National Adult and Influenza Immunization Summit, explained that vaccine manufacturers usually need strain selection finalized by the end of March to ensure timely availability by late July or early August.
The canceled meeting raises the possibility of strain selection being delayed, potentially disrupting the production timeline. While Tan believes that manufacturers could manage with a late decision, any further delay beyond March could cause significant problems in vaccine production.
This cancellation comes amid an especially severe flu season in the U.S., with over 910,000 hospitalizations and at least 86 child deaths, according to the CDC. The Department of Health and Human Services has assured that vaccine recommendations will be made in time for the 2025-2026 flu season, but questions remain about the specific timeline and the FDA’s plans to seek expert input.
Dr. Ofer Levy of Boston Children’s Hospital noted that the World Health Organization’s advisory committee will still meet this Friday to select strains for the Northern Hemisphere’s next flu season. The FDA often follows the WHO’s guidance, but it’s unclear whether drugmakers can begin production based on the WHO’s decision or must wait for the FDA’s approval.
Another concern is whether the FDA will reschedule its advisory committee meeting, which typically requires two weeks’ notice for public comment. If the meeting is not rescheduled, it would be the first time in FDA history that the agency proceeds without input from its expert panel.
Dr. Paul Offit, a member of the FDA’s advisory committee, expressed concern over the cancellation, suggesting it reflects a troubling trend of diminishing reliance on expert advice in public health decision-making. This follows a similar postponement of a CDC vaccine advisory committee meeting earlier this month.
The CDC continues to recommend flu vaccinations for everyone over six months old, and preliminary data indicate that this year’s flu vaccine is effective at preventing hospitalizations, with an effectiveness of 63% to 78% in children and teens, and 41% to 55% in adults.
Despite the uncertainties caused by the canceled meeting, manufacturers like Sanofi and GSK are already preparing for the 2025-2026 season and expect to support final strain selections in time for the upcoming flu season. However, experts warn that delays could cost lives, particularly during a flu season as severe as this one.
