What's Happening?
Vaxart, a biotechnology company based in South San Francisco, has received a stop work order for its Phase IIb trial of an oral COVID-19 vaccine candidate. The order was issued by Advanced Technology International, a nonprofit managing R&D collaborations, and aligns with the U.S. Department of Health and Human Services' (HHS) decision to wind down activities related to mRNA-based vaccine development under the Biomedical Advanced Research and Development Authority (BARDA). Vaxart had enrolled approximately half of the targeted 10,000 participants for the study, which was funded by BARDA. Despite the stop work order, the independent Data Safety Monitoring Board had previously determined the study could continue without modification. Vaxart was not listed among companies whose contracts were terminated by HHS, and the company is allowed to continue follow-up efforts for participants already dosed.
Why It's Important?
The halt of Vaxart's trial reflects broader shifts in U.S. vaccine development priorities, particularly the scaling back of mRNA-related projects by HHS. This decision impacts numerous projects, potentially affecting the pace and direction of COVID-19 vaccine innovation. For Vaxart, the stop work order represents another setback in its vaccine development efforts, following a previous halt in February 2025 that led to workforce reductions. The uncertainty surrounding the trial's future could influence investor confidence and strategic planning within the biotechnology sector. Additionally, the decision underscores the evolving landscape of public health policy and funding allocation in response to changing pandemic dynamics.
What's Next?
Vaxart may seek clarification from HHS regarding the stop work order and explore alternative funding or partnership opportunities to continue its vaccine development. The company might also reassess its strategic focus in light of the shifting priorities in vaccine research. Stakeholders, including investors and public health officials, will likely monitor developments closely to gauge the impact on the broader vaccine development ecosystem. Further announcements from HHS regarding mRNA program adjustments could provide additional context and direction for affected companies.
