health
February 11, 2026
FDA refuses to review Moderna's mRNA flu vaccine
The move comes amid RFK Jr.'s relentless efforts to enact his anti-vaccine agenda.
TL;DR
- The FDA has refused to review Moderna's application for its mRNA flu vaccine, mRNA-1010.
- Moderna was surprised by the FDA's decision, citing the design of the Phase 3 trial, specifically the comparator vaccine used.
- The FDA stated the comparator vaccine did not reflect the 'best-available standard of care'.
- Moderna had previously received FDA acceptance for the trial design on two occasions.
- The mRNA-1010 vaccine was found to be superior to standard-dose influenza vaccines in the trial.
- Moderna plans to meet with the FDA to understand the basis of the refusal.
- The mRNA-1010 vaccine is already under review in the European Union, Canada, and Australia.
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