The Food and Drug Administration’s abrupt decision on Wednesday to cancel next month’s vaccine advisory committee meeting — where experts recommend the strains for next season’s flu shot — is raising concerns about whether the U.S. will have enough of the vaccine for the next flu season.
Drugmakers already face a tight deadline each year to produce enough doses for distribution in the fall.
The federal government typically places preorders for the vaccines in January and February, which appears to have been placed as usual. But drugmakers can’t actually start making the doses until the FDA selects the strains. Shots are usually available by the end of July or early August, said Litjen Tan, co-chair of the flu shot advocacy group the National Adult and Influenza Immunization Summit.
The advisory committee meeting plays a key role, Tan said, because the flu virus is constantly evolving, requiring updates to the vaccine to provide the best protection. This year’s FDA flu meeting was scheduled for March 13, with a final decision from the agency on the strain expected shortly after.
Tan said that depending on the vaccine technology used, manufacturers can wait until late March for input from the FDA on strain selection to produce enough doses for the fall — but no longer.
“If the strain selection happens much later than now, it’s going to be really, really tight, but the manufacturers will scramble and can make it happen,” Tan said. “If the delay is any longer than late March, it’s going to put manufacturers into a huge bind.”
The cancelation of the meeting comes amid a particularly bad flu season this year, with as many as 910,000 hospitalizations so far, according to the Centers for Disease Control and Prevention. At least 86 children and 19,000 adults have died.
In a statement, Andrew Nixon, a senior spokesperson for the Department of Health and Human Services, which oversees the FDA, said the agency will “make public its recommendations to manufacturers in time for updated vaccines to be available for the 2025-2026 influenza season.”
Nixon didn’t answer questions about why the meeting was cancelled or whether the agency would seek input from its outside advisory committee.
Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital, who has advised the FDA on vaccines, said that if the agency decides not to seek input from its committee, it won’t be entirely in the dark.
On Friday, a World Health Organization advisory committee is convening to decide which strains should be included in next season’s flu vaccines for the Northern Hemisphere.
That meeting usually guides the FDA’s strain selection, Levy said.
“FDA has the authority to advance flu vaccines without convening the VRBPAC committee,” he said.
It’s unclear, however, whether drugmakers can begin producing doses for the U.S. based on the WHO’s recommendation or if they must wait for the FDA’s guidance.
It also remains to be seen whether the FDA will reschedule its advisory committee meeting or forgo input on the flu strains from its expert panel altogether — which would be a first for the agency, according to Tan. Typically, the agency must provide two weeks’ notice of a meeting to allow for a public comment period, meaning any advisory committee meeting likely wouldn’t happen until mid-March at the latest.
Dr. Paul Offit, a committee member and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said agency officials offered no explanation for the canceled meeting, nor did they indicate whether it would be rescheduled.
“What worries me about this, I think it’s part of the bigger picture, which is this sort of dissolution of public health infrastructure, that we don’t need experts anymore,” said Offit, who helped develop a vaccine for rotavirus that was later sold to drugmaker Merck. “We don’t need experts advising us at the CDC, we don’t need experts advising us from the FDA. We’ll just figure it out ourselves.”
Earlier this month, federal health officials also abruptly postponed a CDC vaccine advisory committee meeting.
Asked whether he’s concerned about next season’s flu shot supply, Offit said, “I think we’ll have a flu vaccine this year, although I guess I shouldn’t say anything because everything seems unimaginable, and yet it still happens.”
The flu vaccine is recommended for everyone over 6 months old. Data so far show that this year’s flu vaccine is 63% to 78% effective for preventing hospitalization in children and teens, and 41% to 55% effective for adults, the CDC reported Thursday.
If drugmakers don’t have enough time to produce the vaccines because of the canceled meeting, “many lives that could be saved by vaccination will be lost,” said Dr. Tin Tan, president of the Infectious Diseases Society of America.
“This decision — and other federal efforts to undermine well-established science about vaccine safety — puts everyone at risk, especially when we are currently experiencing the worst U.S. flu season in more than a decade,” Tin Tan said.
Flu vaccine manufacturers are still preparing for next year’s flu season.
In a statement, a spokesperson for Sanofi said it has “already begun production for the 2025-2026 flu season in the Northern Hemisphere and will be ready to support final strain selections in time for the season.”
A spokesperson for GSK, another flu vaccine manufacturer, said it’s aware of the canceled meeting and is continuing to work with the FDA on its flu strain recommendation.
