Overview
- Moderna’s amended application seeks full approval for adults 50 to 64 and accelerated approval for those 65 and older with a required post‑marketing study.
- The FDA set August 5, 2026, as the target date to decide on the application.
- The original refusal-to-file cited a control arm for older adults that did not reflect the best-available standard of care, and Moderna said no specific safety or efficacy concerns were identified.
- The reversal unfolds during heightened federal scrutiny of mRNA vaccines under HHS Secretary Robert F. Kennedy Jr., including cuts to mRNA funding.
- Moderna shares rose about 6% after the announcement, and regulators in Europe, Canada and Australia are also reviewing the shot.