The FDA reversed a recent refusal‑to‑file decision and agreed to review Moderna’s mRNA seasonal flu vaccine after a Type A meeting between the company and regulators. The agency had initially objected to aspects of Moderna’s Phase III control arm for adults 65+, saying it did not reflect the best available U.S. standard of care; Moderna proposed an age‑stratified regulatory pathway and supplemental real‑world evidence for older adults. The U‑turn has prompted debate over regulatory consistency and political pressure around vaccine reviews. Commentators and policy analysts are scrutinizing the episode for implications on FDA processes and on how regulators evaluate comparator selection and pragmatic evidence in vaccine trials.