The FDA reversed a recent refusal and agreed to review Moderna’s BLA for its seasonal mRNA influenza vaccine, setting a PDUFA target of Aug. 5, 2026. The decision follows a Type A meeting in which Moderna proposed an amended regulatory strategy that splits indications by age: standard approval for adults 50–64 and accelerated approval for those 65+, with a required post‑marketing study in older adults. Stéphane Bancel, Moderna’s CEO, confirmed agency engagement and the company’s plan to proceed with the amended filing. The reversal stems from internal disagreement at the agency over trial comparators and review pathways; the episode has drawn attention to FDA decision consistency and the operational impact on vaccine makers. The FDA’s move preserves Moderna’s path to market for 2026–27 season supply planning but shifts approval timing and evidence commitments for older adults. Industry watchers will monitor how the decision affects other mRNA vaccine developers and regulatory precedent for age‑stratified approvals.