FDA Accepts Moderna’s mRNA Influenza Vaccine Application After Reversal of Decision
The U.S. Food and Drug Administration has reversed its prior position and accepted Moderna’s biologics license application for its mRNA-based influenza vaccine, initiating a formal review process. Previously, the agency had declined to review Moderna’s application for an “investigational influenza vaccine.” Following submission of an amended application, the FDA has assigned a Prescription Drug User…