Vaxart's Oral Pill COVID-19 Vaccine: A Promising Alternative to mRNA Vaccines

Vaxart, Inc. (Nasdaq: VXRT) has received a positive review from an independent Data Safety Monitoring Board (DSMB) for its COVID-19 Phase 2b clinical trial. The DSMB recommended that the study continue without modifications based on the initial safety assessment of 400 participant 30-day data. This favorable review is a significant milestone for Vaxart, as it paves the way for the trial to progress to enrollment of 10,000 participants, pending approval from the U.S. Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA).

The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study designed to determine the relative efficacy, safety, and immunogenicity of Vaxart's oral pill COVID-19 vaccine candidate compared to an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection. The trial aims to enroll participants in line with U.S. demographics, including at least 25% over the age of 65.

Vaxart's oral pill vaccine offers several potential advantages over mRNA injectable vaccines. One of the primary advantages is the ability to induce mucosal immunity, which is crucial for protecting against respiratory infections like COVID-19. This could be demonstrated by measuring systemic and mucosal immune responses in the trial. Additionally, oral vaccines can be stored and shipped without refrigeration, making them more accessible and easier to distribute, especially in resource-limited settings. This advantage could be highlighted by comparing the stability and storage requirements of Vaxart's vaccine with those of mRNA vaccines. Furthermore, oral vaccines eliminate the risk of needle-stick injury and may be more acceptable to patients who are needle-phobic. This advantage could be demonstrated by comparing patient preferences and satisfaction with the two vaccine administration methods in the trial.

The Phase 2b trial will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and the incidence of adverse events. The primary endpoint is relative efficacy of Vaxart's COVID-19 vaccine candidate compared to an approved mRNA comparator for the prevention of symptomatic disease. Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination.

Funding for this award was received under Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart's project award through the Rapid Response Partnership Vehicle (RRPV) is valued at up to $460.7 million. This project has been funded with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); BARDA, under Other Transaction (OT) number 75A50123D00005.

In conclusion, Vaxart's oral pill COVID-19 vaccine offers a promising alternative to mRNA vaccines, with potential advantages such as mucosal immunity, stability and storage, and ease of administration. The favorable DSMB review and the planned enrollment of 10,000 participants in the Phase 2b trial bring Vaxart one step closer to demonstrating the advantages of its mucosal technology against an approved mRNA vaccine. As the trial progresses, investors should closely monitor the results and the company's strategic initiatives to capitalize on the growing demand for effective and accessible COVID-19 vaccines.