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Published 10 days ago

The FDA’s refusal to review Moderna’s mRNA flu vaccine

STAT News · Feb 12, 2026 · Collected from RSS

Summary

This week on "The Readout LOUD," everything you need to know about the FDA's controversial decision to block the review of Moderna’s mRNA flu shot.

Full Article

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.We’re devoting our entire episode this week to one controversial and impactful topic: the FDA’s decision to block the review of Moderna’s mRNA flu shot. STAT was the first to report that Vinay Prasad, the agency’s top regulator of vaccines, overruled the head of the FDA’s vaccine office and other staffers in making that decision. Prasad’s unilateral action has renewed concerns about the FDA’s regulatory posture under the Trump administration. To help us dig deeply into this important story and its ramifications, we bring on STAT reporters Lizzy Lawrence and Matthew Herper. We also chat with Moderna President Stephen Hoge and former FDA official Jesse Goodman. For more on the FDA’s refusal to review Moderna’s application, go here. For more on Prasad overruling staff, go here. Be sure to sign up for “The Readout LOUD” on Apple Podcasts, Spotify, or wherever you get your podcasts.


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