other material
confidence high
sentiment positive
materiality 0.70
Vaxart completes sentinel cohort enrollment in Phase 2b oral COVID vaccine trial
Vaxart, Inc.
- Sentinel cohort of 400 participants randomized 1:1 to Vaxart's oral pill vaccine or approved mRNA comparator.
- Last dose administered Nov 26, 2024; DSMB and FDA will review 30-day safety data before expanding.
- Upon favorable review and BARDA approval, second part will enroll approximately 10,000 participants.
- Project NextGen award (BARDA) valued at up to $456 million; trial includes >=25% over age 65.
- Primary endpoint is relative efficacy vs mRNA comparator for prevention of symptomatic COVID-19 disease.