Bulwark Takes FDA Reverses Decision About Moderna Flu Vaccine
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Feb 19, 2026 Jonathan Cohn, a health policy reporter and newsletter writer, breaks down the FDA’s sudden flip on Moderna’s mRNA flu vaccine. He walks through why the agency initially refused review, the science and trial-design questions at play, the political interventions that prompted a reversal, and what this all means for vaccine research and industry confidence.
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FDA's Unprecedented Refusal To Review
- The FDA initially refused to even review Moderna's mRNA flu vaccine application, an extremely unusual procedural step.
- That refusal appeared driven by internal leadership intervention rather than standard senior scientist review.
Pre-Submission Agreements Then Reversal
- Moderna followed standard pre-submission meetings with FDA to align on required tests and trial design.
- The agency had previously accepted their approach, making the later refusal especially surprising.
Senior Scientists Were Overruled
- Reporting shows Vinnie Prasad overruled senior scientists to block the application from review.
- That kind of override is rare and signals politicized decision-making at the agency.