FDA reverses course, agrees to review Moderna's flu vaccine [View all]

Source: Statnews

WASHINGTON — The Food and Drug Administration reversed course and told Moderna it would review its application for a new flu vaccine, the company announced Wednesday.

The agency told Moderna earlier this month that it would not review the submission 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.

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.

“We appreciate the FDA’s engagement in a constructive … meeting and its agreement to advance our application for review,” said Stéphane Bancel, Moderna’s chief executive officer of Moderna.”

Read more: https://www.statnews.com/2026/02/18/fda-moderna-reverse-course-flu-vaccine/

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Maybe it is time for Vinay Prasad to find another line of work, since he was the one who overruled career scientists in the vaccine center.

This is the same person who had a problems with the Covid vaccine, with his criticisms bordering on conspiracy rhetoric, with the data or evidence to back it up.