{"id":483448,"date":"2026-02-18T17:30:10","date_gmt":"2026-02-18T17:30:10","guid":{"rendered":"https:\/\/www.newsbeep.com\/ca\/483448\/"},"modified":"2026-02-18T17:30:10","modified_gmt":"2026-02-18T17:30:10","slug":"fda-reverses-course-agrees-to-review-modernas-flu-vaccine","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ca\/483448\/","title":{"rendered":"FDA reverses course, agrees to review Moderna\u2019s flu vaccine"},"content":{"rendered":"

WASHINGTON \u2014 The Food and Drug Administration reversed course and told Moderna it would review its application for a new flu vaccine, the company announced Wednesday.\u00a0<\/p>\n

The agency told Moderna earlier this month that it would not review the submission<\/a> because of a dispute over the design of a clinical trial, sparking an industry backlash and raising questions about broader decision-making at the FDA. The decision was made by top agency official Vinay Prasad, who STAT previously reported had overruled career scientists in the vaccine center<\/a>.\u00a0<\/p>\n

Moderna is trying to secure approval for an mRNA flu vaccine for adults 50 and older. The FDA will now review the product in adults 50 to 64 through a regular pathway, and adults over 65 via accelerated approval with a requirement to run a post-marketing study. The agency will aim to review the vaccine by Aug. 5.\u00a0<\/p>\n

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