The FDA reversed a prior refusal and agreed to review Moderna’s mRNA seasonal influenza vaccine mRNA‑1010, assigning a PDUFA date of Aug. 5, 2026. Regulators and Moderna negotiated an amended filing that proposes traditional approval for adults 50–64 and accelerated approval for those 65 and older, with a post‑marketing study required in the older cohort. The reversal follows a Type A meeting after agency staff initially raised concerns about the trial comparator and design. The episode exposed internal agency tensions and heightened scrutiny of vaccine review standards; company CEO Stéphane Bancel said Moderna appreciates the FDA’s engagement. If approved, mRNA‑1010 would be positioned for the 2026–27 flu season in selected age groups and marks an important test of mRNA vaccines beyond COVID‑19.