FDA Issues Moderna a 75% Refund - Refuses to Review License Application for New mRNA Flu Vaccine
The FDA refused to review Moderna’s license application for the mRNA flu vaccine because its safety and efficacy was compared to a currently licensed flu vaccine as the control group.
February 10, 2026: Moderna just announced that the company received a refusal-to-file letter from the FDA. The FDA is refusing to review the biological license application (BLA) for their investigational flu vaccine, mRNA-1010 and issuing Moderna 75% refund for their license application.
The sole reason for the refusal to initiate the review of Moderna…