Vaxart's COVID-19 Trial Resumes After HHS Lifts Stop Work Order

The stop work order on Vaxart's vaccine research grant has been lifted as of April 24, 2025, according to a U.S. Securities and Exchange Commission filing2.
Vaxart can now resume its next-generation COVID-19 work and will screen participants for its oral vaccine trial4.
The Phase 2b clinical trial received a favorable review from an independent Data Safety Monitoring Board (DSMB) based on initial safety assessment of 400 participant 30-day data3.
Vaxart plans to progress the trial to enrollment of 10,000 participants, pending U.S. Food and Drug Administration (FDA) review and Biomedical Advanced Research and Development Authority (BARDA) approval31.
Prior to the lift of the stop work order, Vaxart had laid off 10% of its workforce5.
The Phase 2b trial is designed to compare Vaxart's oral pill COVID-19 vaccine candidate to an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-193.
Funding for this research comes from Project NextGen, a government initiative supporting next-generation COVID-19 vaccines3.

The trial will continue with the goal of enrolling approximately 10,000 participants to determine the relative efficacy, safety, and immunogenicity of Vaxart's oral pill COVID-19 vaccine compared to existing mRNA options3.

Sources:

1. https://investors.vaxart.com/news-releases/news-release-details/vaxart-highlights-progress-covid-19-norovirus-and-influenza

2. https://firstwordpharma.com/story/5953799

3. https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-favorable-dsmb-review-sentinel-cohort-covid-19

4. https://endpts.com/vaxart-says-stop-work-order-was-lifted-on-next-gen-covid-vaccine/

5. https://sfbn.org/san-francisco-biotech-news/2025/04/28/hhs-lifts-stop-work-order-on-vaxarts-covid-19-trial-continues-funding-for-the-10000-participant-study/