Moderna has received FDA approval for mFLUSIVA (mRNA-1010), a new mRNA-based vaccine against seasonal influenza for adults aged 50 and older. The company said the decision makes mFLUSIVA its fifth approved product globally and fourth FDA-approved product, and its first flu vaccine using mRNA technology.
The approval for adults 50 through 64 years of age is based on a randomized, observer-blind, active-controlled Phase 3 trial that enrolled 40,805 adults across 11 countries. The study evaluated safety, reactogenicity and relative vaccine efficacy versus a standard-dose comparator against RT-PCR-confirmed influenza-like illness caused by influenza A or B strains. Use in adults 65 and older was granted under accelerated approval, supported by immunogenicity data from a separate trial of 2,992 older adults in the United States and descriptive efficacy analysis from the larger Phase 3 study. Confirmation of clinical benefit in this age group will be assessed in a postmarketing trial.
Moderna said the Phase 3 program showed an acceptable safety profile with no new safety concerns, consistent with earlier studies of mFLUSIVA. Chief Executive Officer Stéphane Bancel called the approval an important milestone for the company’s mRNA platform and for public health, noting that flu remains a significant burden for older adults.
The company expects mFLUSIVA supply to be available in select U.S. retailers in the coming weeks, in time for the 2026–2027 respiratory virus season, alongside its COVID-19 and RSV vaccines Spikevax, mNEXSPIKE and mRESVIA. Moderna said mRNA-1010 is under regulatory review in the European Union, Canada and Australia, with additional filings planned later this year.
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