BARDA awards up to $500 million in Project NextGen funding for vaccine clinical trials
The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), is announcing up to $500 million in Project NextGen funding to plan and execute multiple Phase 2b clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.
The project awards were made through BARDA’s Rapid Response Partnership Vehicle (RRPV) to support the following companies in planning for and preparing the vaccine candidates for Phase 2b clinical trials:
- Up to $453 million to Vaxart of San Francisco, California, developing an oral pill vaccine candidate, adenovirus serotype 5 (Ad-5). BARDA will provide an initial $65.7 million for early trial milestones, with remaining funds provided as the effort successfully advances toward trial execution. Vaxart will execute its own Phase 2b clinical trials.
- Approximately $34 million to Castlevax, part of the Mount Sinai Health System in New York City, developing an intranasal vaccine candidate, CVAX-01.
- Approximately $40 million to Cyanvac of Athens, Georgia, developing an intranasal vaccine candidate, CVXGA.
Castlevax and Cyanvac Phase 2b trials are in partnership with BARDA’s Clinical Studies Network.
Each of these three Phase 2b clinical trials will recruit 10,000 volunteers, half of whom will receive one of the investigational vaccines while the other half receives an FDA-licensed vaccine. The efficacy and safety of the investigational vaccines will be compared to the licensed vaccines.
