Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, is the subject of internal complaints alleging misconduct while also overruling staff to return a refusal‑to‑file letter to Moderna for its seasonal influenza mRNA candidate, according to Wall Street Journal reporting. The dispute centers on trial design and choice of comparator; agency reviewers had disagreed with Prasad’s decision and some pushed to proceed with a formal review team. Moderna pushed back publicly, saying its comparator was agreed with CBER prior to the study; company CEO Stéphane Bancel called the decision unexpected. The episode highlights growing agency internal friction and shows how leadership disputes can directly disrupt vaccine review pathways, with potential downstream impacts on sponsor timelines and public‑private vaccine programs.