Vaxart Finishes Sentinel Cohort Enrollment in Phase 2b COVID-19 Oral Pill Vaccine Study

Vaxart, Inc., based in South San Francisco, has successfully completed enrollment for the initial cohort of its Phase 2b clinical trial for an oral COVID-19 vaccine. This study aims to compare the effectiveness of Vaxart's oral pill vaccine against an approved mRNA vaccine. The sentinel cohort consists of 400 participants, with an equal number receiving either Vaxart's vaccine or the mRNA vaccine.

Dr. James F. Cummings, Vaxart’s Chief Medical Officer, expressed satisfaction with reaching this significant milestone, emphasizing the collaborative effort of the team and the commitment of participants and investigators. The data from this cohort will undergo a 30-day safety review by an independent Data and Safety Monitoring Board (DSMB) and the U.S. Food and Drug Administration (FDA). If approved, the trial will proceed to its second phase, involving approximately 10,000 participants, pending further approval from the Biomedical Advanced Research and Development Authority (BARDA).

The trial, designed as a double-blind, multi-center, randomized, comparator-controlled study, aims to assess the relative efficacy, safety, and immunogenicity of Vaxart’s oral COVID-19 vaccine in adults previously vaccinated against COVID-19. It will examine both symptomatic and asymptomatic disease, systemic and mucosal immune responses, and the occurrence of adverse events. The primary objective is to measure the vaccine's effectiveness in preventing symptomatic disease compared to the mRNA vaccine. Final analysis will occur when all participants have completed a 12-month post-vaccination follow-up.

Funding for this research is part of Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID) aimed at accelerating the development of next-generation COVID-19 vaccines and therapeutics. Vaxart’s project, backed by the Rapid Response Partnership Vehicle (RRPV), could receive up to $456 million in funding. This federal support comes from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); and BARDA.

Vaxart has pioneered the development of oral vaccines and was the first U.S. company to complete a Phase 2 clinical trial of an oral COVID-19 vaccine. The company is developing a range of oral recombinant vaccines using its proprietary delivery platform. These vaccines can be administered via pill, eliminating the need for refrigeration and needle-stick injuries, making them more accessible and safer. Vaxart’s pipeline includes vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV), its first immune-oncology indication. The company has filed extensive patent applications to cover its proprietary technology and innovations in oral vaccination methods.

About Vaxart
Vaxart is a clinical-stage biotechnology firm focused on creating oral recombinant vaccines using its unique delivery platform. The company aims to develop oral versions of existing vaccines and create new indications. Its current projects include vaccines for various viruses and a therapeutic vaccine for HPV. Vaxart's proprietary technology allows for vaccines to be administered in pill form, providing convenience and safety advantages.