Overview
- The late-stage trial in roughly 7,500 seronegative women ages 16 to 40 showed only 6% to 23% efficacy at preventing primary CMV infection, far below the company’s target.
- Moderna will discontinue development for congenital CMV and continue a Phase 2 study of mRNA-1647 in bone marrow transplant patients.
- The vaccine was generally well tolerated with a safety profile consistent with earlier studies, and the Data and Safety Monitoring Board reported no safety concerns.
- Moderna plans to share fuller results at a medical meeting to help explain the miss and inform future CMV research.
- The company reaffirmed its 2025 guidance and its expectation to reach cash break-even in 2028, as analysts highlight renewed pressure on its vaccine portfolio.