Clinical TrialJul 7, 2026, 08:07 AM
Vaxart Oral COVID-19 Vaccine Phase 2b Shows Positive Safety Data
AI Summary
Vaxart, Inc. announced positive topline 12-month safety data from the 400-participant sentinel safety cohort of its Phase 2b clinical trial for its oral pill COVID-19 vaccine candidate. The study reported no vaccine-related serious adverse events (SAEs) or sustained Grade 3 or higher adverse events in either the oral vaccine or mRNA comparator arms. The company anticipates full study data, including the main 5,000-participant cohort, in 2027. This project is funded by BARDA under Project NextGen, with an award valued up to $344.8 million.
Key Highlights
- No vaccine-related serious adverse events (SAEs) or sustained Grade 3 or higher adverse events reported in either arm of the study.
- Most common AEs for Vaxart's oral pill vaccine were malaise/fatigue (20.9%), headache (18.9%), and anorexia (10.0%).
- Most common AEs for the mRNA vaccine were injection site pain (60.3%), injection site tenderness (40.2%), malaise/fatigue (35.2%), myalgia (33.2%), and headache (28.6%).
- 33 participants in the oral pill vaccine arm and 30 in the mRNA vaccine arm experienced symptomatic COVID.
- Asymptomatic COVID cases were reported in 12 participants in each arm.
- The 400-participant sentinel safety cohort was not powered to determine comparative efficacy.
- Topline data from the complete 5,400-participant study are anticipated in 2027.
- Project funding received under Project NextGen from BARDA, valued up to $344.8 million.
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