FDA makes flu vaccine recommendations after canceled VRBPAC, closed-door meeting

After canceling a routine meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review the composition of the 2025-2026 influenza vaccine, the US Food and Drug Administration (FDA) on Thursday announced its recommendations for strain selection following a closed-door meeting with other government agencies.

The meeting was not previously announced or open to the public and took place the same day as the previously scheduled VRBPAC meeting would have taken place, though the agency released slides and an agenda for the meeting after it took place. The hour-and-a-half-long meeting was attended by officials from FDA, the Centers for Disease Control and Prevention, and the Department of Defense, and was called to a close 55 minutes before it was scheduled to end, according to a summary released by FDA.

Experts who spoke to Focus expressed concern at the VRBPAC meeting’s cancellation. (RELATED: Flu vaccine advisory committee meeting cancellation raises concerns about HHS’ future, Regulatory Focus 27 February 2025)

FDA said its strain selections are similar to last year’s, and while not mentioning the World Health Organization (WHO) in its statement regarding the selection, the recommendation mirrors WHO’s recommendations for the upcoming flu season in the northern hemisphere. The agency added that it “does not anticipate any impact on timing or availability of vaccines for the American public.”

For egg-based cultures, the strains include an A/Victoria/4897/2022 (H1N1)pdm09-like virus, A/Croatia/10136RV/2023 (H3N2)-like virus, and B/Austria/1359417/2021 (B/Victoria lineage)-like virus, while cell culture-, recombinant protein- or nucleic acid-based vaccines should be comprised of an A/Wisconsin/67/2022 (H1N1)pdm09-like virus, A/District of Columbia/27/2023 (H3N2)-like virus; and B/Austria/1359417/2021 (B/Victoria lineage)-like virus. For quadrivalent vaccines, the B/Yamagata lineage should be added, as was recommended in previous seasons.

During his confirmation hearing, Martin Makary, President Donald Trump’s pick to lead FDA, said he would reevaluate the decision to cancel the meeting with Center for Biologics Evaluation and Research (CBER) leadership, but wouldn’t commit to reinstating the meeting. Makary also expressed skepticism about the meeting’s usefulness, despite the cancellation raising questions about transparency into the agency’s decision making. (RELATED: Senate committee advances Makary nomination, Regulatory Focus 13 March 2025; Makary commits to review FDA staff cuts, VRBPAC cancelation in Senate confirmation hearing, Regulatory Focus 6 March 2025)

Senate Health, Education, Labor and Pensions Chair Bill Cassidy (R-LA) told Makary during the confirmation hearing that the meeting’s cancellation “seems to go backwards” on Department of Health and Human Services Secretary Robert Kennedy’s promise of radical transparency from federal health agencies.

Makary instead criticized the Biden administration for not convening VBRPAC to review COVID-19 vaccine boosters for children during the pandemic and downplayed VRBPAC’s role in flu vaccine strain selection.

“I will say that in my opinion there was a huge difference between requiring every 12-year-old girl in America to take an eighth COVID booster shot versus rubber stamping a recommendation from the international [Global Influenza Program] GIP group, which is done seven out of the last seven years,” Makary said.

Despite Trump’s order for the US to withdraw from WHO, US health officials participated in the GIP meting to select the flu vaccine composition for the northern hemisphere held last month.

FDA

FDA makes flu vaccine recommendations after canceled VRBPAC, closed-door meeting

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