BARDA Funds Vaxart's Phase 2b Study for COVID-19 Oral Vaccine

Vaxart, Inc., a clinical-stage biotechnology firm, has been granted $9.27 million by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to prepare for a Phase 2b clinical trial of its oral XBB COVID-19 vaccine. The study will involve 10,000 subjects and will compare the vaccine's efficacy against an authorized mRNA vaccine.

Dr. Michael Finney, Vaxart’s Interim CEO, expressed gratitude for the BARDA award and emphasized the potential of the oral vaccine platform to change pandemic response and vaccination strategies. According to Dr. James F. Cummings, Vaxart’s CMO, the oral vaccine could address needle-phobia and speed up vaccination efforts. It is also designed to be thermostable, offering cross-reactivity against various SARS-CoV-2 strains and long-lasting immunity.

The initiative is part of Project NextGen, a $5 billion HHS program aimed at creating vaccines and therapeutics with more extensive and enduring protection than the first generation of COVID-19 vaccines. Vaxart's platform aligns with BARDA's goals of inducing mucosal immunity and a cross-reactive response to multiple COVID variants.

The funding comes from the Department of Health and Human Services, highlighting the government's commitment to advancing public health through innovative solutions. Vaxart's focus is on developing oral recombinant vaccines that can be stored and shipped without refrigeration, reducing the risk of needle-stick injuries. The company holds patents for its technology and is developing vaccines for a range of diseases, including coronaviruses, norovirus, influenza, RSV, and HPV.

Vaxart's mission is to revolutionize the field of vaccination with its proprietary pill-based delivery system, which could lead to the development of oral versions of existing vaccines and new vaccines for emerging health threats. The company's innovative approach has the potential to increase vaccination rates and provide robust protection against a variety of infectious diseases.