mRNA-1010 - (P304)

June 18, 2026: Moderna, Inc. (NASDAQ: MRNA) reported that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously (9-0) that the benefits of mRNA-1010, its investigational seasonal influenza vaccine, outweigh the risks for prevention of influenza disease in adults ages 50–64, and separately voted 9-0 for adults ≥65. The committee discussion included data from Moderna’s Phase 3 clinical program, including primary analysis results from the pivotal Phase 3 trial NCT06602024 (previously announced June 2025 and published in The New England Journal of Medicine). Moderna stated the Phase 3 safety profile was consistent with previously reported studies. The FDA will consider VRBPAC’s non-binding recommendation as part of its ongoing review of Moderna’s Biologics License Application (BLA) for mRNA-1010; the PDUFA goal date remains August 5, 2026. Moderna also said mRNA-1010 has been accepted for regulatory review in the U.S., EU, Canada, and Australia, with additional country submissions planned during 2026.