FDA Issues 2025-26 Flu Vaccine Recommendations Without Advisory Input

The FDA has issued recommendations for the 2025-26 flu vaccine composition without consulting its usual independent advisory committee, a deviation from standard practice. The decision followed the abrupt cancellation of the Vaccines and Related Biological Products Advisory Committee meeting, which typically reviews and votes on vaccine strain recommendations. Instead, the recommendations were made internally by FDA, CDC, and Department of Defense experts, advocating for a trivalent vaccine targeting H1N1, H3N2, and a Victoria-lineage subtype. While the FDA ensures there will be sufficient vaccine supply, the cancellation has raised concerns about the exclusion of external expert input. Simultaneously, the U.S. is experiencing one of the worst flu seasons in over a decade, with hospitalization rates at a 15-year high, highlighting the urgent need for effective vaccines.