The FDA reversed an initial Refuse‑to‑File decision and agreed to review Moderna’s mRNA influenza vaccine application after a Type A meeting between agency staff and the company. The U‑turn followed internal and external scrutiny of trial comparator choices and regulatory expectations, prompting political attention and debate over agency leadership and decision‑making. The reversal unfolded amid heightened scrutiny of the FDA’s vaccine and vaccine‑policy processes and drew comment from senior officials and White House actors. The episode has intensified debate about agency consistency and review standards for novel mRNA vaccines, with implications for sponsors designing comparators and accelerated approval pathways.