Vaxart, Inc. released topline 12-month safety data from the sentinel safety cohort of its Phase 2b clinical trial for its oral pill COVID-19 vaccine candidate. The trial involved approximately 400 participants, with 201 receiving Vaxart's oral vaccine and 199 receiving an approved mRNA vaccine. No vaccine-related serious adverse events (SAEs) or sustained Grade 3 or higher adverse events (AEs) were reported in either the oral vaccine group or the mRNA vaccine group. Common AEs for the oral vaccine included malaise/fatigue (20.9%), headache (18.9%), and anorexia (10.0%). Common AEs for the mRNA vaccine included injection site pain (60.3%), injection site tenderness (40.2%), malaise/fatigue (35.2%), myalgia/muscle pain (33.2%), and headache (28.6%). Symptomatic COVID cases were reported in 33 participants in the oral vaccine arm and 30 in the mRNA arm. Asymptomatic COVID cases were reported in 12 participants in each arm. The safety cohort was not powered to determine comparative efficacy. Topline data from the complete study, including a main cohort of approximately 5,000 participants, are anticipated in 2027. The main cohort is designed to provide a statistical comparison of safety and relative efficacy. Funding for the trial is supported by Project NextGen, an initiative by BARDA and NIAID, with Vaxart's project award valued at up to $344.8 million.