Overview
- The FDA set August 5, 2026 as the target decision date for Moderna’s amended biologics application.
- Moderna now seeks full approval for ages 50–64 and accelerated approval for 65+, tied to a post-marketing trial in seniors.
- The initial refuse-to-file cited the Phase 3 control arm for older adults as not reflecting the U.S. best standard of care, and did not allege safety or efficacy issues.
- Company-reported Phase 3 data in roughly 40,000 adults found the shot about 27% more effective than a standard comparator vaccine from GSK.
- The dispute unfolded during tightened mRNA oversight under HHS Secretary Robert F. Kennedy Jr., with reports that CBER head Vinay Prasad overruled staff; regulators in Europe, Canada and Australia are also reviewing the vaccine, which could reach the 2026–27 flu season if approved.