mFlusiva becomes the first mRNA influenza vaccine approved by the FDA

mFlusiva, the first mRNA influenza vaccine, received FDA approval for adults 50 to 64 and accelerated approval for those 65 and older, based on superior vaccine efficacy shown in the FLUENT trial. The approval process involved a brief refusal-to-file by the FDA, leadership changes, and stringent postmarketing study commitments, creating uncertainty around Advisory Committee on Immunization Practices recommendations for the 2026-2027 flu season.

This Wire brief sits within Fusion42's coverage of Health, and 12 sources have reported it between 6 Aug 2026 and 27 Aug 2026.