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Despite Safety Concerns, FDA Approves Moderna’s mRNA Flu Shot

Despite Safety Concerns, FDA Approves Moderna’s mRNA Flu Shot

On Aug. 5, 2026, the U.S. Food and Drug Administration (FDA) approved Moderna’s seasonal flu shot, mFLUSIVA (mRNA-1010), making it the first messenger RNA platform for seasonal influenza in the United States. The decision permits health care providers to use mRNA technology for annual influenza vaccination in eligible age groups.1 FDA regulators approved mFLUSIVA to […]

FDA Greenlights Review of Moderna’s mRNA Flu Shot After Application Amended

FDA Greenlights Review of Moderna’s mRNA Flu Shot After Application Amended

On Feb. 18, 2026, the U.S. Food and Drug Administration (FDA) agreed to review Moderna’s application for its mRNA influenza shot, known as mRNA-1010, after the company amended its submission to address regulatory concerns. The agency accepted the updated biologics license application and set a target action date of Aug. 5, 2026, allowing the shot […]

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