The U.S. Food and Drug Administration accepted Moderna’s amended application for its mRNA influenza vaccine after initially refusing to review the submission. Moderna and the agency agreed an amended filing that splits regulatory pathways: full approval for adults 50–64 and accelerated approval for those 65 and older, with a post‑marketing study requirement for the older cohort. Moderna said the FDA aims to complete its review by Aug. 5. The agency’s reversal follows internal disputes over trial design and underscores growing regulatory scrutiny around novel mRNA vaccine trial paradigms. The decision affects timing for the 2026–27 flu season and sets precedent for mRNA vaccine filings beyond COVID-19.