Trump official overruled FDA scientists to reject Moderna's flu shot
4 hours ago
- #Moderna
- #FDA
- #vaccine-regulation
- Vinay Prasad, Trump's FDA vaccine regulator, overruled scientists to reject Moderna's mRNA flu vaccine review.
- FDA scientists, including David Kaslow, opposed Prasad's decision, providing detailed reasons for proceeding with the review.
- An hourlong meeting in January saw FDA scientists objecting to Prasad's stance, calling it the wrong approach.
- Prasad's objection was not about Moderna's mRNA vaccine but the comparator vaccine used in a Phase 3 trial.
- Moderna noted FDA's prior reviews of trial plans were without objection, though suggestions for a different comparator for older participants were made.