Vaxart Announces Favorable DSMB Review of Sentinel Cohort from COVID-19 Phase 2b Clinical Trial

Core Insights - An independent Data Safety Monitoring Board (DSMB) has recommended that Vaxart's COVID-19 Phase 2b trial proceed without modifications based on a safety assessment of 30-day data from 400 participants [1][2] - The trial aims to enroll approximately 10,000 participants, pending favorable review from the FDA and approval from BARDA [1][2] - Vaxart's Phase 2b trial is designed to compare the efficacy, safety, and immunogenicity of its oral COVID-19 vaccine candidate against an approved mRNA vaccine [3] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [6] - The company has received funding under Project NextGen, a $5 billion initiative aimed at accelerating the development of innovative COVID-19 vaccines and therapeutics, with Vaxart's project award valued at up to$460.7 million [4] - Vaxart is recognized as a pioneer in oral vaccines, being the first U.S. company to complete a Phase 2 clinical trial for an oral COVID-19 vaccine [5]