The FDA abruptly reversed course and agreed to review Moderna’s mRNA influenza vaccine candidate mRNA-1010, setting a PDUFA target date of Aug. 5, 2026. The agency moved from a refusal-to-file stance to acceptance after a Type A meeting in which Moderna proposed a revised regulatory approach that divides indications by age and commits to a post‑marketing study in older adults. Moderna will seek standard approval for adults 50–64 and accelerated approval for those 65 and older, with a required post-approval trial in the latter group. The decision follows public controversy over earlier internal disagreements at the FDA and underscores regulatory uncertainty affecting vaccine developers. The turnaround has immediate implications for vaccine timelines and market planning: if approved, mRNA-1010 could be available for the 2026–27 flu season for targeted age groups. Industry watchers are watching both the agency’s handling of mRNA dossiers under new leadership and the precedent the reversal sets for future vaccine reviews.