FDA Rejects Moderna’s Application for mRNA Flu Shot

The pharmaceutical company said it is seeking a meeting with the agency to understand the path forward.

The Moderna logo is displayed on a cellphone, in this photo illustration taken on May 3, 2022. REUTERS/Dado Ruvic/Illustration

The Food and Drug Administration is refusing to review Moderna’s experimental influenza vaccine, the company announced on Feb. 10.

In a letter published by Moderna, FDA Center for Biologics Evaluation and Research (CBER) Director Dr. Vinay Prasad wrote to the company that the refusal stems from the design of Moderna’s study of its messenger ribonucleic acid (mRNA) flu shot.