FDA's Abrupt Flip-Flop on Moderna's mRNA Flu Shot Highlights Growing Risks to Drug-Makers of Investing in Vaccines

FDA's abrupt flip-flop on Moderna's mRNA flu shot highlights growing risks to drug-makers of investing in vaccines

The Food and Drug Administration's decision, made public on Feb. 10, 2026, to not review an application to approve Moderna's proposed mRNA-based flu vaccine set off a firestorm of criticism from public health experts.

Why did FDA refuse Moderna's flu application?

What regulators decided and why it matters U.S. regulators told the company that its marketing application would not be accepted for review after examining the clinical evidence the company submitted. The Food and Drug Administration questioned whether the trial design and the comparison vaccine…

Kennedy’s FDA Refuses to Review Moderna’s mRNA Flu Vaccine Application:

his decision leaves us more exposed during the next influenza shift This week, the FDA declined to even consider Moderna’s application to license its new mRNA influenza vaccine. This, despite strong clinical trial results. Those results, published in the New England Journal of Medicine, which found that Moderna’s mRNA flu vaccine was more than 20% more effective than a traditionally produced influenza vaccine in adults. Efficacy, Immunogenicity,…