FDA Reverses Decision, Agrees to Review Moderna's mRNA Flu Vaccine Application

FDA Reverses Decision, Agrees to Review Moderna's mRNA Flu Vaccine Application

The U.S. Food and Drug Administration (FDA) has reversed its earlier decision and agreed to review Moderna's application for its mRNA-based flu vaccine. Initially, the FDA had declined to review the application due to concerns about the study design. This reversal means that the vaccine could potentially be available before the next flu season. The decision marks a significant development in the regulatory process for Moderna's innovative flu vaccine technology. The review will take place in the United States, where both the FDA and Moderna are based. This update reflects the FDA's willingness to reconsider the application, potentially impacting flu prevention efforts in the upcoming season.

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U.S. Food and Drug Administration Moderna

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United States

Articles

February 18, 2026
2 total
FDA Reverses Decision, Agrees to Review Moderna's mRNA Flu Vaccine Application
FDA Reverses Decision, Agrees to Review Moderna's mRNA Flu Vaccine Application

The Conversation • 18 Feb 23:46

The FDA has reversed its earlier decision and will now review Moderna's application for an mRNA-based flu vaccine, potentially allowing its availability for the upcoming flu season.

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FDA Reverses Decision, Agrees to Review Moderna's mRNA Flu Vaccine
FDA Reverses Decision, Agrees to Review Moderna's mRNA Flu Vaccine

The Guardian • 18 Feb 17:26

The FDA has agreed to review Moderna's mRNA-based flu vaccine after initially declining the application, potentially allowing the vaccine to be available before the next flu season.

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