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.
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.
The vaccine development has been funded through a $460.7 million project award received under Project NextGen, an initiative by the Biomedical Advanced Research and Development Authority (BARDA) to accelerate and streamline the development of the next generation of innovative COVID vaccines, therapeutics and enablers.
Back in February, Vaxart was hit with a stop work order for the project from Department of Health and Human Services. The order was lifted in April, with the stipulation that Vaxart would have further discussions with BARDA regarding costs, timelines, and a regulatory pathway agreement.