FDA Declines to Review Moderna’s mRNA Flu Vaccine Application

THURSDAY, Feb. 12, 2025 (HealthDay News) — In a major blow to vaccine development, the U.S. Food and Drug Administration (FDA) said it will not review Moderna’s application for the first mRNA-based flu shot.

Dr. Vinay Prasad, the nation’s top vaccine regulator, told the company it lacked an "adequate and well-controlled" study, Moderna said in a statement earlier this week.

"We’re trying right now to reach out to the FDA and understand what would be necessary for them to start reviewing the submission," Moderna President Stephen Hoge told The Washington Post.