The FDA initially rejected Moderna's application for its mRNA flu vaccine (mRNA-1010) for adults 50+ due to concerns over the clinical trial design, specifically using a standard-dose flu vaccine as the control instead of a high-dose one.123
The FDA reversed its decision and accepted a revised application, with full review for adults 50-64 and accelerated approval for those 65+ requiring a post-marketing study.134
The target decision date is August 5, 2026, potentially allowing availability for the fall flu season.1234
The reversal followed industry backlash, prior FDA acceptance of the trial design in 2024, and possible external pressures including White House involvement.23
Moderna CEO Stephane Bancel welcomed the FDA's engagement via a Type A meeting.3
Experts noted confusion over the FDA's inconsistent approach under current leadership, impacting vaccine development confidence.3
Sources:
1. https://www.statnews.com/2026/02/18/fda-moderna-reverse-course-flu-vaccine/
2. https://www.politico.com/news/2026/02/18/fda-reverses-course-on-moderna-flu-shot-bid-00785799
3. https://www.cidrap.umn.edu/influenza-vaccines/double-reverse-fda-now-says-it-will-review-moderna-s-mrna-flu-vaccine
4. https://www.powershealth.org/about-us/newsroom/health-library/2026/02/19/modernas-mrna-flu-vaccine-back-under-fda-review