The FDA agreed to advance Moderna’s mRNA seasonal flu vaccine application after a Type A meeting, reversing a prior refuse‑to‑file action and assigning a PDUFA date of August 5. Moderna proposed a revised regulatory pathway that seeks full approval for adults 50–64 and accelerated approval for those 65 and older, with post‑marketing studies required in the older cohort. Moderna framed the outcome as constructive engagement with regulators and indicated it expects to make the vaccine available later this year pending approval. Reporting from Politico linked the agency’s reversal to political pressure, citing an unnamed source who said the White House intervened — an assertion denied by an unnamed White House official. The FDA’s decision renews focus on regulatory consistency for mRNA vaccines and on how external factors may affect review timelines.