Vaxart announced the first patient was dosed in the 10,000-participant portion of its ongoing Phase 2b clinical trial evaluating its oral pill COVID-19 vaccine candidate.
“Initiating dosing in the 10,000-participant portion of this study is a significant step forward in the development of our oral COVID-19 vaccine candidate,” said Steven Lo, Chief Executive Officer of Vaxart. “Following the lift of the stop work order, we quickly reactivated our clinical trial sites, screened patients, and shipped clinical trial material that enabled us to start dosing patients. We look forward to progressing this trial and continuing to collaborate with our government partners."
The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study. It is designed to evaluate the relative efficacy, safety, and immunogenicity of Vaxart's oral COVID-19 vaccine candidate compared to an approved mRNA COVID-19 vaccine in adults who have previously been vaccinated against COVID-19.
This portion of the trial follows a positive review of the 30-day safety data from the sentinel cohort of 400 participants by an independent Data Safety Monitoring Board (DSMB). As announced previously, the DSMB recommended that the study proceed without modifications.
Funding for this award was received under Project NextGen, an initiative by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart’s project award through the Rapid Response Partnership Vehicle (RRPV) Consortium is valued at up to $460.7 million. This project has been funded with federal funds from BARDA, under Other Transaction (OT) number 75A50123D00005.
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