FDA clears Moderna’s first mRNA flu shot for adults 50 and older

The Food and Drug Administration approved Moderna’s mFlusiva for adults 50 and older, making it the first mRNA-based seasonal flu vaccine cleared in the United States. The agency granted traditional approval for people ages 50 to 64 after a late-stage trial of more than 40,000 adults found about 27% fewer flu cases than with a licensed standard-dose shot. For adults 65 and older, the FDA used accelerated approval based on data showing stronger antibody responses than Sanofi’s high-dose vaccine, with Moderna required to submit more evidence from an additional study. Moderna said some doses should reach select retailers within weeks, ahead of the 2026-27 flu season.