FDA Refuses To Review Moderna's Application For New mRNA-Based Flu VaccineThe U.S. Food and Drug Administration is refusing to review Moderna’s application for a new mRNA flu vaccine, the pharmaceutical company said in an announcement Tuesday that called the refusal “inconsistent” with the government’s prior feedback.Moderna said it received a “refusal-to-file letter” from the FDA that objected to how the company carried out a 40,000-person clinical trial on the vaccine. That’s despite both sides previously discussing and agreeing upon how the study would be done prior to its start, Moderna CEO Stéphane Bancel said."This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America's leadership in developing innovative medicines," Bancel said in a statement, which referred to the FDA’s Center for Biologics Evaluation and Research.The refusal comes months after the Department of Health and Human Services canceled contracts and halted funding for mRNA technology, which Health Secretary Robert F. Kennedy Jr. has been critical of.Moderna said its mRNA vaccine has been accepted for review in the European Union, Canada and Australia, and that it has requested a meeting with the FDA “to understand the path forward.”See All UpdatesClose