After initially issuing a Refusal to File over comparator and study‑design concerns, the FDA reversed course and agreed to review Moderna’s seasonal influenza BLA for mRNA‑1010. Moderna said it reached agreement in a Type A meeting and proposed an age‑stratified regulatory pathway with a PDUFA date set for August 5, 2026. The reversal follows public scrutiny of the agency’s earlier decision and underlines regulatory volatility affecting novel vaccine modalities. FDA objections centered on the elderly comparator arm; Moderna proposed accelerated pathways and post‑marketing commitments for older adults. The episode highlights ongoing tension between innovative mRNA vaccine developers and evolving regulatory expectations.