On August 6, the U.S. FDA approved mFLUSIVA® (mRNA-1010), Moderna’s seasonal influenza vaccine, for adults 50 years of age and older. mFLUSIVA is the first FDA-approved mRNA influenza vaccine and Moderna’s fourth FDA-approved product.
The approval was supported by a Phase 3 clinical development program. In adults 50 years of age and older, a randomized, observer-blind, active-controlled trial involving more than 40,000 participants evaluated safety, reactogenicity, and relative vaccine efficacy compared with a licensed standard-dose influenza vaccine.
For adults 65 years of age and older, accelerated approval was based on immunogenicity data comparing mFLUSIVA with a licensed high-dose influenza vaccine, together with supportive efficacy findings. Continued approval in this age group is contingent upon confirmation of clinical benefit in a postmarketing study.
Across the Phase 3 program, mFLUSIVA demonstrated an acceptable safety profile, with no new safety concerns identified. Moderna expects mFLUSIVA to be available at select U.S. retailers for the 2026–2027 respiratory virus season.
For additional information, I’ve included the news release and Prescribing Information below:
News Release: Moderna Receives U.S. FDA Approval for Influenza Vaccine mFLUSIVA
Full Prescribing Information: Package Insert and Information for Patients - MFLUSIVA