WASHINGTON — The U.S. Food and Drug Administration has approved the first messenger RNA-based seasonal influenza vaccine for adults aged 50 and older, granting Moderna authorization to market its vaccine, mFlusiva, in a milestone for the company's mRNA platform beyond COVID-19 vaccines.
The FDA granted traditional approval for adults aged 50 through 64 and accelerated approval for adults aged 65 and older, with the latter contingent on Moderna completing post-marketing studies to confirm the vaccine's clinical benefit in older adults, according to the company and U.S. regulators.
The approval marks the first time mRNA technology has been authorized for the prevention of seasonal influenza in the United States. Unlike conventional flu vaccines, which are commonly produced using egg-based or cell-based manufacturing, mRNA vaccines can be updated more rapidly to better match circulating influenza strains.
The decision was supported by results from a late-stage clinical trial involving more than 40,000 participants. Moderna said the vaccine demonstrated approximately 26.6% to 27% greater efficacy than a standard-dose influenza vaccine and generated stronger immune responses than a high-dose comparator in older adults. No major new safety concerns were identified during the study, according to reported trial data.
The approval follows a closely watched regulatory review that earlier this year included an initial refusal by the FDA to accept Moderna's application before the agency later agreed to review it under separate approval pathways for different age groups. An FDA advisory committee subsequently voted unanimously in favor of recommending approval.
Moderna said it plans to make mFlusiva available for the 2026-27 influenza season. The FDA's accelerated approval for adults aged 65 and older remains subject to confirmatory studies.
