In Rare Move, FDA Refuses to Review Moderna’s mRNA Flu Vaccine

The FDA has delivered an unusually blunt rebuke to Moderna, refusing even to review the company’s application for an mRNA-based flu vaccine. In a February 3rd letter, the agency issued what’s known as a “refuse-to-file” decision, telling Moderna that its submission failed a basic requirement: it did not include an “adequate and well-controlled” clinical trial. […]