The FDA has approved Moderna’s mFLUSIVA (mRNA-1010), the first mRNA-based influenza vaccine in the U.S., for the prevention of seasonal influenza in adults ages 50 and older. The decision follows a monthslong regulatory process that included the agency’s initial refusal to review the application, a subsequent reversal and a unanimous recommendation from an FDA advisory committee.
In February, the FDA agreed to review Moderna’s application after initially declining to file it because of questions about the design of a phase 3 trial. Under the revised regulatory strategy, Moderna sought traditional approval for adults ages 50 to 64 and accelerated approval for adults 65 and older, while agreeing to conduct a postmarketing study in the older population if the vaccine was approved.
The FDA’s Vaccines and Related Biological Products Advisory Committee unanimously recommended approval in June. At the meeting, FDA staff said the vaccine was about 27% more effective than a standard flu shot in a late-stage trial. The committee also recommended approval for adults 65 and older contingent on Moderna completing the confirmatory postmarketing study.
The approval for adults ages 50 through 64 was based on a phase 3 trial involving 40,805 adults across 11 countries, according to an Aug. 5 news release. Accelerated approval for adults 65 and older was based on a separate clinical trial of 2,992 U.S. participants, with confirmation of clinical benefit to be evaluated after launch. Moderna said it expects mFLUSIVA to be available in select retailers in the coming weeks for the 2026-2027 respiratory virus season.
The Infectious Diseases Society of America welcomed the approval, calling it “another important option” to help protect against influenza, according to an Aug. 6 statement. Ronald Nahass, MD, the organization’s president, said the approval demonstrates the potential of mRNA technology to enable faster vaccine development and responses to emerging viral mutations.
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