What is the story about?
What's Happening?
The Biomedical Advanced Research and Development Authority (BARDA) has issued a stop work order on Vaxart's Phase IIb trial for its oral COVID-19 vaccine candidate. This decision coincides with the Department of Health and Human Services' (HHS) announcement to wind down mRNA vaccine development activities, affecting numerous projects. Vaxart had enrolled half of the targeted participants for the trial, which was part of a contract with BARDA initiated in June 2024.
Why It's Important?
The halt in Vaxart's trial reflects broader shifts in U.S. vaccine development priorities, particularly concerning mRNA technologies. This decision impacts Vaxart's efforts to advance its oral vaccine, which could have offered a novel administration method for COVID-19 prevention. The move underscores the challenges faced by biotech companies in navigating regulatory and funding landscapes, affecting innovation and potential market entry.
What's Next?
Vaxart is allowed to continue follow-up efforts for participants already dosed, but the future of the trial remains uncertain. The company may need to reassess its strategy and explore alternative funding or partnerships to advance its vaccine candidate. The broader implications of HHS's decision could influence the direction of vaccine research and development in the U.S., affecting stakeholders across the biotech industry.
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