The U.S. FDA has approved Moderna’s mRNA flu vaccine, mFlusiva (mRNA-1010), marking the first licensed seasonal influenza shot built on an mRNA platform. Coverage starts for adults aged 50 to 64 and adults 65 and older, with the older-group indication tied to follow-up postmarketing study requirements. The approval follows a high-profile regulatory turnaround earlier in the year. Moderna previously disclosed an initial FDA refusal-to-file decision and then received a reversal after an FDA meeting. The new authorization comes as the company positions mRNA as a faster manufacturing approach than egg-based production for seasonal strain changes. Separately, STAT reports on additional FDA approval activity—framing a broader moment for U.S. regulators—while the Moderna approval underscores how mRNA is again becoming a mainstream option for seasonal immunization despite earlier political headwinds around the platform.