Internal dissent at the FDA surfaced after agency leadership, led by Vinay Prasad, overruled vaccine-review teams on Moderna’s submission—actions that industry sources say changed the outcome of a review-ready file. Reporting from STAT and other outlets indicates senior CBER staff and reviewers were prepared to accept the application for review but were overruled by office leadership. Experts and vaccine executives warned that the decision could chill investment in next-generation vaccine development and reshape sponsor‑agency interactions. The move has provoked public pushback from industry figures and sparked debate about consistency and predictability in vaccine regulation, with observers noting potential downstream effects on global vaccine programs and manufacturer trial design choices.