FDA Does Sharp U-Turn On Application For Moderna Flu Vaccine

The F.D.A. didn't give a detailed explanation yesterday as to why it suddenly changed direction
By Susie Madrak — February 19, 2026

The FDA this week agreed to begin review of the latest Moderna flu shot after shooting it down. Why?

Well, the F.D.A. didn't give a detailed explanation yesterday as to why it suddenly changed direction. But the initial refusal to even consider the application drew a lot of public criticism, and startled Big Pharma as well as investors. Blackstone alone invested $750 million in Moderna’s development of a flu vaccine.

Industry executives have gotten vocal about expressing their opinions about the administration’s destruction of vaccine policy and the F.D.A.’s recent pattern of rejecting drugs after years-long agreements on study standards. A number of drug companies have also raised similar concerns after the F.D.A. refused to review their applications or denied approvals.

Dr. Stephen Hoge, Moderna’s president, said on Fox Business this week that Moderna and other drug developers needed clear and consistent rules from regulators. “What we can’t have is somewhat arbitrary changes to those rules after the game has been played,” he said.

Breaking News: The FDA reversed its decision on Moderna’s mRNA flu vaccine and agreed to review it for possible approval, Moderna said.

— The New York Times (@nytimes.com) 2026-02-18T13:55:41.539129Z

US says that it will review Moderna flu vaccine it previously declined https://aje.news/uylmdz

— Al Jazeera English (@aljazeera.com) 2026-02-18T18:30:05.974Z

NEW: "This was not a decision to reject the Moderna vaccine. It was a refusal even to think about approving it."
www.thebulwark.com/p/this-is-wh...

— Adam Keiper (@adamkeiper.com) 2026-02-15T13:30:10.451Z

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