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FDA cancels advisory committee's flu shot meeting amid uncertainty in HHS leadership

As the nation prepares for its next flu season, key discussions on vaccine composition are on hold.
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The Food and Drug Administration abruptly canceled its advisory committee meeting, which is tasked with recommending the composition of annual flu shots.

The Vaccines and Related Biological Products Advisory Committee was scheduled to meet on March 13 and discuss the composition of the 2025-26 flu shots. Traditionally, the committee meets each winter to issue recommendations on the following season's flu vaccines.

Influenza vaccines are adjusted annually to best target the most prominent strains of the virus. Vaccine manufacturers then have several months to translate these government recommendations into the following season's flu shot.

Dr. Paul Offit, a pediatrician with the Children's Hospital of Philadelphia and a member of the committee, told Scripps News that the meeting would not be rescheduled. He added that the Food and Drug Administration will issue its own recommendations concerning flu vaccines without the help of the Vaccines and Related Biological Products Advisory Committee.

In a statement, the FDA confirmed Offit's statement.

"The FDA will make public its recommendations to manufacturers in time for updated vaccines to be available for the 2025-2026 influenza season," the agency said.

"I guess the FDA has decided they don't need an independent group of experts to help them out," he said.

"We meet in March to pick flu strains for what is a six-month production cycle," he added. "Therefore, the vaccines can be ready by September. By canceling this meeting, that means that someone else is going to be making this decision, but it has to be made soon."

Offit notes that creating a flu shot is a "moving target" as the strain changes every year. He said members of his committee often look at what strains are circulating in the Southern Hemisphere in the spring as a potential clue for what strains could circulate in the U.S. the following flu season.

"We're not always right, but usually pretty close to being right," he said. "Not only does it sort of mutate from one year to the next so that natural infection or immunization the previous year doesn't protect you, but it even mutates during the season. So, the virus continues to change."

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The cancellation of this meeting follows the postponement of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices meetings, which were scheduled for this week. That committee was set to vote on recommending RSV vaccines for adults, along with making other recommendations for influenza, meningococcal, and chikungunya vaccines.

Additionally, the CDC committee was also scheduled to hear a presentation regarding Moderna's Phase 3 trial of a COVID-19 vaccine that the company has highlighted for its easier storage compared to other COVID-19 shots.

It is unclear whether these meeting disruptions are related to new leadership at the Department of Health and Human Services. Robert F. Kennedy Jr., a vaccine skeptic, now leads HHS, which oversees the Food and Drug Administration and the CDC. Although he states he is not anti-vaccine, he has frequently expressed skepticism regarding the safety and efficacy of routine vaccinations. Kennedy had previously indicated that he would not reduce access to vaccines during his confirmation.

RELATED STORY | Moderna to present combo COVID-flu vaccine to regulators after trial

The Vaccines and Related Biological Products Advisory Committee has postponed hearings in the past. In May 2024, the committee delayed a meeting by several weeks to gather more information on COVID-19 vaccines before issuing a final recommendation for the 2024-25 vaccine.

The CDC reports this year has been more active for flu activity. So far, the CDC estimates that there have been at least 24 million illnesses, 310,000 hospitalizations, and 13,000 deaths caused by the flu.