Following a positive safety review, Vaxart advances its needle-free, room-temperature stable oral vaccine candidate with government-backed funding and a year-long follow-up study.
Image credits: Vaxart
Vaxart, Inc has initiated dosing in the 10,000-participant segment of its ongoing Phase 2b trial evaluating an oral COVID-19 vaccine candidate. This randomized, double-blind, multi-center study compares the efficacy, safety, and immunogenicity of Vaxart’s oral vaccine to an approved mRNA vaccine in adults previously vaccinated against COVID-19. The expansion follows a positive 30-day safety review by an independent Data Safety Monitoring Board (DSMB) of the initial sentinel cohort of 400 participants, which recommended continuing the trial without modifications.1
In today's press release, Steven Lo, chief executive officer of Vaxart, emphasized the importance of recent progress, stating, “Initiating dosing in the 10,000-participant portion of this study is a significant step forward in the development of our oral COVID-19 vaccine candidate.” He added, “Following the lift of the stop work order, we quickly reactivated our clinical trial sites, screened patients, and shipped clinical trial material that enabled us to start dosing patients. We look forward to progressing this trial and continuing to collaborate with our government partners.”1
Earlier this year, in January 2025, we reported the DSMB’s favorable review, which enabled the study’s progression into this larger cohort. The ongoing trial includes a 12-month follow-up period to assess safety, immunogenicity, and efficacy. Vaxart’s oral vaccine employs a proprietary pill delivery platform designed to eliminate the need for refrigeration and needle administration, with the aim of eliciting both systemic and mucosal immune responses. This platform offers potential logistical advantages, such as room temperature stability and ease of administration without medical personnel.2
Vaxart has expanded dosing to 10,000 participants in its Phase 2b oral COVID-19 vaccine trial after a positive safety review of the initial sentinel cohort.
The oral vaccine uses a pill-based platform that is room temperature stable and needle-free, designed to elicit both systemic and mucosal immune responses.
Supported by $460.7 million in federal funding through Project NextGen, the trial includes a 12-month follow-up to evaluate safety, efficacy, and immunogenicity.
Funding for the trial is provided through Project NextGen by the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), with up to $460.7 million awarded through the Rapid Response Partnership Vehicle Consortium. Vaxart is developing oral recombinant vaccines not only for COVID-19 but also for other viral infections, including norovirus, influenza, and human papillomavirus.2
In our previous interview with James F Cummings, MD, Vaxart’s chief medical officer, discussed the significance of the DSMB’s safety review and the vaccine’s potential as an alternative to injectable options. He stated, “To date, Vaxart’s vaccine platform has maintained a clean safety profile in studies comprising more than 800 participants across our pipeline of vaccines. While Vaxart remains blinded, we are encouraged that, after careful review, the DSMB has authorized this study to continue, without modification, into the 10,000 person cohort, the next step in this study upon favorable review from FDA and following BARDA approval.”2
Cummings further outlined key milestones for the trial’s next phase: “This 10,000 person cohort should take about six months to fully enroll. There is then a 12-month follow-up period for safety, immunogenicity, and efficacy. We will remain blinded until the last study volunteer completes their 12-month follow-up visit, then complete our analysis of these key features (safety, efficacy, and immunogenicity).”2
