It’s hard to recall a regulator who has done as much damage to medical innovation in as little time as Vinay Prasad. In his latest drive-by shooting, the leader of the Food and Drug Administration’s vaccine division rejected Moderna’s mRNA flu vaccine without even a cursory review. This is arbitrary government at its worst.
The FDA rarely refuses to review a drug or vaccine application. Our sources say the FDA has rejected only about 4% of applications without a review, typically when they are missing important information. That wasn’t the case with Moderna.
Dr. Prasad spiked Moderna’s flu vaccine because its Phase 3 trial was putatively not “adequate and well-controlled.” He quibbled that the control group in Moderna’s late-stage trial didn’t receive the “best-available standard of care.” He decides what is “best.”
Moderna launched a global randomized controlled trial in September 2024 with 41,000 participants, half of whom received its vaccine. The other half received a standard flu vaccine as a control. The FDA blessed its trial design, and agency staffers gave Moderna a thumbs up to apply for approval last August based on the results. Its vaccine was 27% more effective at preventing symptomatic cases of flu and 49% more effective against hospitalization than the standard flu vaccine.
The WSJ Editorial Board weighs in:
— Amy Siskind 🏳️🌈 (@Amy_Siskind) February 13, 2026
“It’s hard to recall a regulator who has done as much damage to medical innovation in as little time as Vinay Prasad. In his latest drive-by shooting, the leader of the Food and Drug Administration’s vaccine division rejected Moderna ’s mRNA flu…
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