The U.S. Food and Drug Administration reversed a refusal-to-file decision and agreed to review Moderna’s BLA for its seasonal mRNA influenza vaccine mRNA-1010, setting a PDUFA goal date of Aug. 5, 2026. Moderna said the agency accepted an amended filing that splits regulatory pathways by age group: traditional approval for adults 50–64 and accelerated approval for those 65 and older with a required post‑marketing study. The reversal follows a Type A meeting between Moderna and FDA after career reviewers and senior agency leadership had been at odds over the Phase 3 comparator. Moderna’s CEO Stéphane Bancel called the meeting “constructive.” The outcome restores a potential 2026–27 season launch for the company’s mRNA flu candidate and highlights continuing regulatory unpredictability for vaccine developers. Industry readers should note the procedural detail: the FDA’s approach ties approval routes to age cohorts and mandates additional real‑world data collection in older adults. The decision sets a precedent for how the agency may handle mRNA platform vaccines going forward and underscores the operational risks developers face when trial comparators or design raise agency concerns.