Health

FDA Panel Backs Moderna's mRNA Flu Vaccine for Adults Over 50

Was the FDA blocking American vaccine innovation or rightfully demanding Moderna prove its efficacy?

Published 1 hour ago

FDA Panel Backs Moderna's mRNA Flu Vaccine for Adults Over 50

Story

Above: Moderna logo in Warsaw, Poland, on April 9, 2025. Image credit: Jakub Porzycki/NurPhoto/Getty Images

The Spin

Narrative A

The FDA's initial refusal to even review Moderna's mRNA flu vaccine was a regulatory disaster. Moderna ran a 43,000-person trial under an FDA-approved design, proved superiority over both standard-dose and high-dose comparators, and still got stonewalled. The EU, Canada and Australia are moving forward with reviews while American innovation gets left behind. Unpredictable regulation doesn't protect the public; it just drives vaccine development offshore.

CIDRAP

Richard Hanania on X

Narrative B

Moderna compared its mRNA flu vaccine to the weakest available flu shot, not the high-dose formulation that's been the evidence-based benchmark for older adults for nearly a decade, thereby setting an easy target. Regulatory predictability matters, but so does comparator integrity; clearing a low bar doesn't mean a product is actually better. Real innovation means proving superiority over the best available option, not the most beatable one.

Dr. Syed Haider on X

Anil Makam on Substack