FDA’s Center for Biologics Evaluation and Research director Vinay Prasad returned Moderna’s mRNA-1010 influenza application and is facing internal complaints alleging interpersonal misconduct and procedural overreach. Reporting by The Wall Street Journal and STAT News describes staff pushback over Prasad’s decision to issue a refusal-to-file (RTF) despite an assembled review team that had previously engaged with Moderna on trial design. Moderna publicly disputed the RTF, with CEO Stéphane Bancel arguing the company had agreed the comparator strategy with CBER before initiating the study. Internal memos from CBER reviewers, including David Kaslow of the Office of Vaccines Research and Review, reportedly urged against blocking the submission. The dispute mixes scientific debate over control-arm standards with allegations of Prasad’s personal impropriety, raising regulatory and staffing risk for vaccine reviews. For industry executives and regulatory affairs teams, the episode signals heightened scrutiny of trial comparator choices and the potential for leadership disputes at CBER to slow vaccine reviews. Companies planning vaccine submissions should anticipate intensified internal deliberations within the agency and prepare to document early alignment with review divisions. Sources: Wall Street Journal, STAT News, company statements.