The FDA reversed a recent refuse‑to‑file (RTF) decision and agreed to review Moderna’s mRNA influenza vaccine mRNA‑1010, assigning a PDUFA date and reopening a regulatory pathway after a Type A meeting. Moderna said it proposed an age‑stratified regulatory approach that could seek full approval for ages 50–64 and accelerated approval for those 65 and older. The reversal follows agency concerns that Moderna’s Phase III comparator for older adults did not reflect the best US standard of care. CBER officials had flagged the choice of control in 65+ patients; Moderna proposed a pragmatic post‑approval real‑world study for the older cohort. Moderna CEO Stéphane Bancel welcomed the engagement; the agency’s about‑face underscores ongoing regulatory friction around mRNA vaccine development and trial design. The episode also highlights how rapid interactions with FDA leadership can resolve major filing disputes.