Moderna secured a last-minute regulatory reprieve: the FDA reversed an initial Refusal to File and will now accept review of the company’s mRNA influenza vaccine, mRNA-1010, after a Type A meeting. The agency’s earlier concern centered on the trial’s control arm for adults 65+, which CBER said did not reflect U.S. standard-of-care comparators. Moderna proposed an age-stratified regulatory pathway — full approval for ages 50–64 and accelerated approval plus a pragmatic post-approval study for 65+ — and engaged in a focused meeting that cleared the way for review. Company CEO Stéphane Bancel framed the outcome as constructive engagement with regulators. The episode highlights growing friction between sponsors and reviewers over comparator selection and trial design in vaccine submissions, and it underscores political and leadership scrutiny at FDA. The U-turn may influence how sponsors design pivotal vaccine studies going forward.