The FDA reversed an earlier refuse‑to‑file decision and agreed to review Moderna’s revised mRNA influenza vaccine submission after the company amended its filing and the agency held an internal senior‑leader meeting. The regulator will consider full approval for adults 50–64 and accelerated approval for those 65 and older, with a post‑marketing study required in older adults. Moderna and STAT reporting show the U‑turn followed high‑level discussions at the agency; the FDA set an August 5 target date for a decision. The split‑indication approach means Moderna may need additional data to win full approval in the oldest cohort, while accelerated approval would permit earlier access pending confirmatory evidence. The reversal highlights an unusual, high‑visibility deviation from prior FDA practice and leaves open questions about internal review processes and precedent for future mRNA vaccine filings.
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