F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine

Christina Jewett and Rebecca Robbins / nytimes - Moderna said it had held further discussions with regulators and announced that the agency would accept the company’s application for approval of its flu vaccine that uses mRNA technology.

AI Summary: After renewed discussions with the company, the FDA reversed its earlier stance and agreed to accept Moderna’s amended application for an mRNA seasonal influenza vaccine. Regulators will now evaluate the submitted safety and efficacy data to determine whether the shot meets approval standards — a regulatory about-face that will keep flu-watchers and investors awake.

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