Key Highlights

  • Moderna received FDA approval for mFLUSIVA, the first mRNA-based influenza vaccine, for use in adults 50 years of age and older.
  • The approval follows unanimous recommendations from the FDA's Vaccines and Related Biological Products Advisory Committee and marks Moderna's fourth FDA-approved product and fifth approved product globally.
  • The Phase 3 trial supporting the approval enrolled 40,805 adults aged 50 and older across 11 countries, while use in adults 65 and older was granted accelerated approval based on a separate trial of 2,992 participants.
  • Moderna expects mFLUSIVA to be available in select U.S. retailers in the coming weeks, in time for the 2026-2027 respiratory virus season.

FDA Approves First mRNA-Based Flu Vaccine

Moderna (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration has approved mFLUSIVA, a new vaccine against seasonal influenza, for use in all adults 50 years of age and older. The approval follows unanimous recommendations from the FDA's Vaccines and Related Biological Products Advisory Committee supporting mFLUSIVA for this age group. Chief Executive Officer Stephane Bancel said the approval represents Moderna's fourth approved product in the United States and the first mRNA-based flu vaccine, calling it a demonstration of the continued strength and versatility of the company's mRNA platform. The approval marks mFLUSIVA as Moderna's fifth approved product globally.

Approval Based on Large-Scale Phase 3 Trial Data

The FDA's approval of mFLUSIVA in adults 50 through 64 years of age is based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial that enrolled 40,805 adults aged 50 and older across 11 countries, evaluating the vaccine's safety and relative efficacy against a standard-dose active comparator. Use in adults 65 years of age and older was granted accelerated approval based on a separate randomized trial enrolling 2,992 adults in the United States, which evaluated immunogenicity against a high-dose inactivated influenza vaccine comparator, with confirmation of clinical benefit in this population to be assessed in a postmarketing study. The Phase 3 program demonstrated an acceptable safety profile, with no new safety concerns identified.

Approval Follows Reversal of Earlier Regulatory Setback

The approval caps an unusual regulatory path for mFLUSIVA, which appeared uncertain as recently as February 2026, when the FDA's then-head of biologics issued a rare refusal-to-file notice citing Moderna's use of a standard-dose rather than high-dose comparator in its pivotal trial. That decision was reversed within days following public backlash and a formal meeting with the agency, clearing the way for the vaccine's review to proceed toward Wednesday's approval. Moderna said it expects mFLUSIVA to be available in select U.S. retailers in the coming weeks, positioning the vaccine for the 2026-2027 respiratory virus season alongside the company's existing Spikevax, mRESVIA, and mNEXSPIKE products. Regulatory submissions for mRNA-1010 are also under review in the European Union, Canada, and Australia, with additional country submissions planned during 2026.

Conclusion

The FDA approval of mFLUSIVA represents a significant milestone for Moderna's mRNA platform, both as the company's fourth approved U.S. product and as the first mRNA-based influenza vaccine to reach the market. The approval's path, which included an early regulatory setback before its reversal, underscores the scrutiny mRNA-based products have faced even as the underlying science continues to expand into new therapeutic areas. Broader adoption of mFLUSIVA in the coming flu season, along with continued regulatory progress internationally, may serve as an early indicator of the vaccine's commercial trajectory.