FDA Rejects Moderna's mRNA Flu Vaccine Application

The United States===Food and Drug Administration (FDA) has refused to review Moderna's application for its first mRNA-based flu shot, citing that the clinical trial's comparator vaccine was not the 'best-available standard of care'. This decision, communicated via a 'refusal-to-file' letter signed by Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, has been deemed inconsistent with previous communications by Moderna CEO Stéphane Bancel. The move comes amidst heightened scrutiny of mRNA technology under Health Secretary Robert F. Kennedy Jr., who has expressed skepticism about vaccines and canceled federal funding for mRNA development. Moderna's shares dropped 8% following the announcement. While the FDA did not identify any safety or efficacy concerns, the rejection poses a significant setback for Moderna's expansion into the flu vaccine market in the United States, although the vaccine is under review in Europe, Canada, and Australia.