Moderna Says FDA Refuses To Review Its Application for Experimental Flu Shot

The Food and Drug Administration has refused to start a review of Moderna’s application for its experimental flu shot, the company announced Tuesday, in another sign of the Trump administration’s influence on tightening vaccine regulations in the U.S. Moderna said the move is inconsistent with previous feedback from the agency from before it submitted the application and started phase three trials on the shot, called mRNA-1010. The drugmaker said it has requested a meeting with the FDA to “understand the path forward.”

Moderna noted that the agency did not identify any specific safety or efficacy issues with the vaccine, but instead objected to the study design, despite previously approving it. The company added that the move won’t impact its 2026 financial guidance. Moderna’s jab showed positive phase three data last year, meeting all of the trial goals. At the time, Moderna said the stand-alone flu shot was key to its efforts to advance a combination vaccine targeting both influenza and Covid-19.