FDA greenlights Moderna's mRNA flu shot for adults, promising faster production

On 5 August, the U.S. Food and Drug Administration granted full approval to Moderna’s mRNA influenza vaccine, mFLUSIVA, for people aged 50-64 and accelerated approval for those 65 and older, with availability expected in the coming weeks for the 2026-27 flu season. Clinical data from more than 40,000 participants indicated a 2 % infection rate among mFLUSIVA recipients versus 2.8 % for a standard non-mRNA comparator, reflecting a 26.6 % relative reduction in confirmed cases.

Scientists praised the mRNA technology for its rapid redesign capability, which could alleviate traditional manufacturing delays. Moderna will conduct a confirmatory phase IV trial in seniors to compare efficacy against an enhanced vaccine. The product is under review by regulators in the European Union, Canada and Australia, and follows the earlier EU approval of Moderna’s combined flu-COVID shot, mCombriax. Side effects were mostly mild, though injection-site pain occurred more frequently than with conventional vaccines.