Moderna’s New Flu Shot Hits a Roadblock

The U. S. Food and Drug Administration has decided not to review Moderna’s mRNA flu vaccine, even though the company spent years and millions of dollars on testing. The decision came after the agency’s chief vaccine regulator, Dr. Vinay Prasad, raised a concern. He said the trial used a comparison vaccine that the FDA does not view as the best option on the market. Participants in the control group received Fluarix Quadrivalent, a product made by GSK. Moderna enrolled 41, 000 people in its study, focusing on adults aged 50 and older. The company reported that its vaccine performed better than the GSK product in the trial.Stephen Hoge, Moderna’s president, said the new shot is designed to suit one country better than vaccines that cover an entire hemisphere. He also noted that the FDA had previously shown support for Moderna’s study plan. Hoge expressed confusion over the sudden refusal to start a review. He called it surprising and said the company is trying to understand what changed. A spokesperson for the Department of Health and Human Services, which oversees the FDA, declined to comment on individual applications. The agency said it does not discuss communications with specific applicants. This move highlights growing tension between the federal health agency and vaccine developers.