The FDA approved Moderna’s mRNA influenza vaccine, mFlusiva (mRNA-1010), marking the first licensed U.S. seasonal flu shot built on mRNA technology. Clearance covers adults aged 50 to 64 and adults 65 and older, with the latter group receiving accelerated approval contingent on a postmarketing study. Moderna’s path included a rare “refusal-to-file” decision earlier in the year that was later reversed after the company and FDA aligned on the review package. Trial data previously indicated the vaccine reduced influenza-like illness risk by about 27% versus a standard-dose comparator in older adults. The approval broadens the use of mRNA platforms beyond COVID-19 and is likely to reshape how flu vaccine manufacturers think about manufacturing lead times and strain updates.