Trump Administration Cancels FDA Vaccine Advisers Meeting (2)

The Trump administration has canceled an upcoming meeting of the Food and Drug Administration’s vaccine advisory committee, a move that could complicate efforts to produce flu shots in time for the upcoming season.

The Vaccines and Related Biological Products Advisory Committee, which evaluates immunization data for the FDA, had planned to meet in March to discuss the composition of next season’s flu vaccine. The meeting is a routine but critical step in ensuring manufacturers have sufficient time to produce doses ahead of the next flu season.

The meeting was originally planned for March 13, but several committee members were notified late Wednesday afternoon that it had been canceled.

“That was the word” that was used, said Paul Offit, a professor of pediatrics at the Children’s Hospital Philadelphia and a member of the advisory panel who received the email Wednesday at 4:18 p.m. No reason was provided, and there was no indication of whether it would be rescheduled, Offit and two other panel members said.

In a brief email Thursday, Andrew Nixon, a spokesperson for the Department of Health and Human Services, confirmed the cancellation, and said the FDA would “make public its recommendations to manufacturers in time for updated vaccines to be available for the 2025-2026 influenza season.”

The timing of the meeting is crucial because flu vaccine production is a lengthy process, with some doses still made using chicken eggs. Each year, FDA advisers meet to formally decide which flu strains to include, typically aligning with recommendations from the World Health Organization. Once selected, manufacturers need about six months to produce large quantities of the vaccine. Any significant delay in this process could mean the vaccine isn’t ready in time for the next flu season.

The FDA can make recommendations to flu vaccine manufacturers without the advisory panel. However, eliminating advisory panels removes a key layer of public accountability and transparency in the FDA’s decision-making process.

‘In the Dark’

“We have this meeting every year. It’s how pharmaceutical companies determine which strains to use,” Offit said. “I don’t understand. We’re all just sort of left in the dark.” He added that it was unclear who had ordered the cancellation or why.

A representative for one major flu shot manufacturer who asked not to be identified said the company was in a wait-and-see mode. While some manufacturing can go on without the strain selection decision, the longer the delay goes on, the more uncertainty it creates around the manufacturing process, the person said. The company will continue with manufacturing for markets other than the US based on the WHO’s recommendations, the person said.

FDA advisory panels don’t issue binding decisions, but they serve an essential role in publicly reviewing data and guiding major regulatory actions. The vaccine advisory panel played a key role during the pandemic, debating whether to authorize mRNA-based Covid vaccines from Moderna Inc. and Pfizer Inc.

The cancellation of this meeting raises concerns that other federal health advisory panels may also be in jeopardy. Since President Donald Trump’s inauguration, the FDA hasn’t posted any new expert advisory panel meetings on its website, and a separate advisory panel on surgical medical devices — previously scheduled for this month — was postponed.

By this point in February 2024, at least three FDA advisory panels had already met, with three more officially scheduled for March, according to archived versions of the agency’s website.

The cancellation comes as the US grapples with its worst seasonal flu epidemic in over 15 years. The move is likely to raise further questions about vaccine policy under the new Health and Human Services secretary, Robert F. Kennedy Jr., a longtime vaccine critic.

It also marks the second time in a week that a major government vaccine advisory meeting has been called off. The Advisory Committee on Immunization Practices, or ACIP, which makes national vaccine recommendations, was scheduled to meet this week to review immunization data, but the meeting was postponed.

(Updates with HHS comment in the 5th paragraph.)

--With assistance from Ashleigh Furlong.

To contact the reporters on this story:
Robert Langreth in New York at rlangreth@bloomberg.net;
Gerry Smith in New York at gsmith233@bloomberg.net

To contact the editors responsible for this story:
Cynthia Koons at ckoons@bloomberg.net

Jason Gale, John Lauerman

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