FDA Advisory Committee Votes Unanimously (9-0) in Favor of Moderna's mRNA Flu Vaccine

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously 9-0 that the benefits of Moderna's mRNA-1010 (mFLUSIVA) investigational seasonal influenza vaccine outweigh its risks for adults aged 50–64, and voted 9-0 again that the same benefit-risk conclusion applies to adults 65 and older. Moderna is seeking standard approval in the younger age group and accelerated approval (with a postmarketing confirmatory study) for the 65-plus group. The pivotal Phase 3 trial enrolled 40,805 adults across 301 sites in 11 countries and showed 26.6% relative vaccine efficacy against RT-PCR-confirmed influenza-like illness versus a standard-dose comparator, rising to 47.9% efficacy against emergency room visits, hospitalizations, and urgent care encounters. The unanimous vote — a rare outcome for FDA advisory panels — clears the way for a potential approval by the August 5, 2026 PDUFA date, which would make mRNA-1010 the first mRNA-based seasonal influenza vaccine licensed in the US, in time for the 2026–2027 flu season.