Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, is facing internal complaints and public scrutiny tied to his handling of Moderna’s influenza vaccine submission. Reports cite allegations of interpersonal misconduct and staff pushback after Prasad returned a refusal-to-file letter for Moderna’s mRNA-1010 application. Agency staff reportedly disagreed with Prasad’s intervention, arguing that an assembled review team was prepared to evaluate the submission. Moderna countered that its study design had been discussed with FDA reviewers in advance. The discord has spilled into coverage by The Wall Street Journal and statements from HHS and Moderna. The episode underscores operational strain within CBER and may shape industry expectations for vaccine reviews, particularly where leadership interventions overturn or preempt career reviewers’ plans.