BARDA Awards $9.27 Million Contract to Evaluate Oral Pill COVID Vaccine

Biotechnology firm Vaxart, Inc. announced on Jan. 19, 2024 that it received a $9.27 million contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to fund preparations for a Phase IIb clinical trial to evaluate the company’s oral pill XXB COVID-19 vaccine candidate. The trial is expected to involve 10,000 participants and will compare Vaxart’s oral pill vaccine candidate to an approved mRNA (messenger ribonucleic acid) biologic.^{1 2 3 4}

“We are very honored to receive this BARDA award, which will support the innovative approach of our oral pill vaccine platform,” said Michael Finney, PhD, Vaxart’s interim chief executive officer. “We believe our oral pill vaccine platform may ultimately hold the promise of revolutionizing how we fight pandemics and how we vaccinate against several infectious diseases.”^{2 4}

According to Vaxart’s chief medical officer, James Cummings, MD, the company’s oral pill vaccine could improve existing COVID biologics in “two important ways”…

First, a thermostable pill vaccine such as Vaxart’s offers the chance to overcome needle-phobia, a documented obstacle to vaccination, and offers the potential to make it easier to vaccinate more people faster than with traditional injected vaccines. Second, our previous research on other vaccine constructs found Vaxart’s oral pill vaccine to be cross-reactive against all tested SARS-CoV-2 variants and to trigger long-lasting immune responses, potentially offering broader, longer protection than the current first-generation vaccines. We believe our vaccine does this by triggering both a systemic and mucosal response.^{2 4}

Additionally, Vaxart’s oral pill vaccine platform eliminates the need for refrigeration during storage and transportation, allowing more convenience and flexibility to those delivering and administering the drug. It also eliminates the risk of “needle-stick injury.”^{1 3}

The contract to Vaxart was awarded as part of a $5 billion initiative called Project NextGen, which is based at the U.S. Department of Health and Human Services (HHS) and led by the Administration for Strategic Preparedness and Response’s (ASPR) BARDA and the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID).⁵

The goal of Project NextGen is to foster the development of groundbreaking vaccines and therapeutics that provide “broader and more durable protection against COVID-19 than the first generation COVID vaccines and medicines.”^{2 3 4 5}

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