Overview
- Moderna’s amended filing seeks full approval for adults 50 to 64 and accelerated approval for those 65 and older with a required post‑marketing study in seniors.
- The FDA set an August 5, 2026 decision date, and the vaccine could reach adults 50+ for the 2026–2027 flu season if approved.
- The earlier refusal-to-file, signed by CBER director Vinay Prasad, said the Phase 3 control arm for seniors did not use the U.S. best-available high‑dose comparator.
- Moderna and multiple reports say the letter cited no safety or efficacy concerns; company data showed roughly 27% higher efficacy versus GSK’s Fluarix in adults 50+.
- The high-profile back-and-forth comes during broader U.S. policy shifts on mRNA under HHS Secretary Robert F. Kennedy Jr., and Moderna shares rose about 5–6% after the reversal.