Overview
- In a Feb. 3 refusal-to-file letter, FDA vaccine chief Vinay Prasad said Moderna’s application lacked an “adequate and well-controlled” trial because the control did not reflect the best-available standard of care.
- Moderna’s Phase 3 trial enrolled about 40,700 participants, used GSK’s Fluarix as the comparator, and reported roughly 26.6% higher effectiveness versus that standard shot.
- The company says FDA had previously cleared the protocol, it supplied supportive analyses against a high-dose vaccine for seniors, and the agency cited no safety or efficacy deficiencies.
- Moderna has requested a Type A meeting with the FDA to determine a path forward while parallel reviews continue in the EU, Canada and Australia.
- An HHS spokesperson said Moderna ignored clear 2024 guidance to use a CDC-recommended high-dose control for older adults, and CNN reported internal debate within the FDA over the refusal.