The FDA reversed an earlier refusal-to-file and agreed to review Moderna’s seasonal mRNA flu vaccine application, setting a PDUFA target date of Aug. 5. The company proposed an age‑stratified regulatory pathway: full approval for adults 50–64 and accelerated approval for those 65+, with post‑marketing study requirements in older adults. Moderna framed the outcome as the result of a productive Type A meeting with CBER; CEO Stéphane Bancel issued a statement thanking the agency. Coverage from Politico cited unnamed sources alleging a White House phone call to FDA leadership preceded the agency’s reversal, a claim the White House denied. For developers and investors, the episode underscores how high‑visibility political and regulatory interactions can reshape the review timeline for novel vaccine platforms and influence competitive dynamics in seasonal vaccine markets.