The FDA’s Center for Biologics Evaluation and Research (CBER) returned a refusal-to-file (RTF) for Moderna’s influenza vaccine application after CBER director Vinay Prasad overruled internal reviewers, prompting internal complaints and external pushback. Reporting in The Wall Street Journal and follow-ups in STAT and Fierce Biotech detail staff disagreements over trial design and comparator choice, while Moderna CEO Stéphane Bancel publicly criticized the decision. The dispute centers on whether Moderna’s study used an FDA‑approved comparator and whether the review team should have been allowed to proceed. HHS acknowledged a diversity of views within the review team. The episode raises near-term regulatory risk for industry vaccine sponsors and spotlights leadership and process questions inside CBER.