The FDA reversed its earlier 'refusal to file' decision and will now review Moderna's mRNA flu vaccine application (mRNA-1010 or mRNA-100) for adults 50 and older123
Initial rejection stemmed from a dispute over the clinical trial design, specifically using a standard-dose flu shot instead of a high-dose one for adults 65+, decided by FDA official Vinay Prasad124
Moderna amended its application:
full approval sought for ages 50-64 via regular pathway, accelerated approval for 65+ with a required post-marketing study in older adults1234
FDA aims to complete review by August 5, 2026; Moderna targets availability for the 2026-27 flu season123
The decision followed a Type A meeting and industry backlash, amid questions about FDA consistency under current leadership134
Moderna CEO Stéphane Bancel welcomed the FDA's engagement, emphasizing benefits for seniors23
Sources:
1. https://www.statnews.com/2026/02/18/fda-moderna-reverse-course-flu-vaccine/
2. https://www.cbsnews.com/news/moderna-fda-flu-vaccine-mrna-reverse-decision/
3. https://www.cidrap.umn.edu/influenza-vaccines/double-reverse-fda-now-says-it-will-review-moderna-s-mrna-flu-vaccine
4. https://cen.acs.org/pharmaceuticals/vaccines/Regulatory-whiplash-FDA-decides-review/104/web/2026/02