FDA chooses flu vaccine strains despite cancelled meeting
The FDA has released its recommendations on the composition of influenza vaccines for the 2025-26 season – without the input of its external advisors.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) had been scheduled to meet to discuss the strains that should be included in the seasonal vaccine yesterday but was abruptly cancelled by new Health and Human Services (HHS) Secretary Robert F Kennedy Jr soon after he took on the role.
The FDA said its recommendations have been made "following a thorough and comprehensive review of US and global surveillance data," adding that it "does not anticipate any impact on timing or availability of vaccines for the American public."
The prompt publication of the recommendations – which are close to the strains selected last year – has likely come in response to criticism of the decision to cancel the meeting and concerns that any delay could make it hard for pharma companies to make the 2025-26 shots, as the manufacturing processes for flu vaccines – particularly those still made in chicken eggs – can take months.
The FDA said it had opted instead to convene a behind-closed-doors meeting of scientific and public health experts from the FDA, CDC, and Defense Department to arrive at its position, which is to recommend a trivalent vaccine including two influenza A subtypes (H1N1 and H3N2) and one influenza type B strain (B/Victoria lineage).
Along with cancelling the VRBPAC meeting, Kennedy also postponed a meeting of the CDC's Advisory Committee on Immunisation Practices (ACIP), which had been due to discuss a range of topics, including the use of recently approved RSV vaccines in the coming season.
The two decisions – and the announcement of a commission to investigate "threats" to children's health in the US that has medication and vaccines in its scope – have raised concerns that anti-vaccine sentiment has started to creep into the US regulatory system.
"The FDA anticipates that there will be an adequate and diverse supply of approved trivalent seasonal influenza vaccines" for the upcoming season, said the agency in its statement.
President Donald Trump's nomination to head the FDA, Dr Martin Makary, was pressed on the decision to cancel the VRBPAC meeting at a hearing in front of the Senate Health, Education, Labor, and Pensions (HELP) committee earlier this month, saying he believed VRBPAC was merely 'rubber stamping' the decisions made by the WHO's Global Influenza Programme (GIP).
The GIP's own recommendations, published in February, also called for H1N1, H3N2, and B/Victoria lineage strains for vaccines intended for the 2025-26 season.
