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FDA在没有AdCom参与的情况下发布流感疫苗建议

2025-03-14 19:07

The U.S. Food and Drug Administration (FDA) has issued its recommendations to vaccine makers on which virus strains to select when manufacturing influenza (flu) vaccines for the 2025-2026 U.S. flu season.

However, unlike previous years, the agency has released its annual update without feedback from its Vaccines and Related Biological Products Advisory Committee (VRBPAC).

“With today’s action, the FDA does not anticipate any impact on the timing or availability of vaccines for the American public,” the FDA said in a statement on Thursday, adding, “The recommendations are similar to the previous year’s strain selection.’

For the 2025-2026 season, the FDA recommends trivalent flu vaccines comprising two strains of influenza A and one strain of influenza B.

The agency said it arrived at the decision following a meeting with scientific and public health experts from the FDA, the CDC, and the Department of Defense, who took into consideration the data related to currently circulating flu viruses.

The announcement comes on the day the agency previously planned to conduct a VRBPAC meeting to obtain expert advice on the flu strain selection for next season’s flu vaccines.

However, last month, without explanation, the FDA abruptly canceled the meeting as part of many changes the agency has implemented since the appointment of Robert F. Kennedy Jr., a well-known vaccine skeptic, to the position of Health and Human Services secretary.

Flu vaccine makers include: CSL Limited (OTCQX:CSLLY) (OTCQX:CMXHF), GSK (NYSE:GSK), Sanofi (NASDAQ:SNY) (OTCPK:SNYNF) (GCVRZ), and AstraZeneca (NASDAQ:AZN) (OTCPK:AZNCF)

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