The U.S. Food and Drug Administration reversed a recent refusal-to-file and agreed to review Moderna’s mRNA seasonal influenza vaccine mRNA-1010, assigning a PDUFA target date of Aug. 5, 2026. The agency agreed Moderna will pursue full approval for adults 50–64 and accelerated approval for those 65 and older, with a required post‑marketing study in older adults. Moderna and FDA officials reached the change after a Type A meeting in which Moderna proposed an amended regulatory strategy. The reversal follows public controversy around the agency’s earlier refusal, which cited concerns about comparator selection in Moderna’s phase 3 trials and prompted industry scrutiny of internal review decisions. The new pathway preserves Moderna’s plan to have the shot available for older adults for the 2026–27 flu season if approved.