Vaxart announced that it received a project award valued at up to $453M through the Rapid Response Partnership Vehicle, or RRPV. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority, or BARDA, part of the Administration for Strategic Preparedness and Response, or ASPR, in the U.S. Department of Health and Human Services, or HHS. The funds will be used to conduct a Phase 2b comparative study evaluating Vaxart’s oral pill COVID-19 vaccine candidate against a FDA-approved mRNA vaccine comparator. In preparation for the trial, Vaxart created and manufactured under Good Manufacturing Practice, or GMP, standards a next-generation oral COVID-19 vaccine tablet candidate that – based on preclinical data – is more potent than Vaxart’s prior COVID-19 vaccine constructs. Funding under the award will be provided in two parts with approximately $65.7M available immediately to continue study start-up activities, and the remainder of approximately $387.2M provided when Vaxart and BARDA have determined that the study may further proceed and paid over the course of the study. Currently, Vaxart anticipates initiating enrollment as early as summer 2024. An interim analysis for vaccine efficacy compared to an approved mRNA comparator may occur as early as the first quarter of 2025.
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