The FDA agreed to reconsider Moderna’s seasonal mRNA influenza vaccine mRNA-1010 after a rapid Type A meeting, setting a target PDUFA date of August 5. Moderna proposed an age‑stratified regulatory pathway — full approval for adults 50–64 and accelerated approval for those 65+ with post‑marketing studies in older adults. The company cited constructive engagement with the agency and signaled readiness to make the vaccine available later this year. The episode followed an earlier Refusal‑to‑File letter and public reporting that the fast turnaround may have been prompted by high‑level pressure. Moderna and FDA publicly framed the outcome as a regulatory resolution; outside reports in Politico cited a presidential inquiry into agency handling. The case underscores the intersection of regulatory detail (choice of comparators and trial design) and political scrutiny in high‑profile vaccine reviews.
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