The Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, yesterday announced up to $500 million in Project NextGen funding to plan and conduct multiple phase 2b clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.
Assistant Secretary for Preparedness and Response Dawn O'Connell, JD, said, "The next generation vaccines that BARDA is investing in may bolster our protection against COVID-19 and be easier to administer through intranasal or oral delivery."
The project awards were made through BARDA's Rapid Response Partnership Vehicle to support the following companies in readying their vaccine candidates for phase 2b clinical trials:
- Up to $453 million to Vaxart of San Francisco for 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, to develop its intranasal vaccine candidate, CVAX-01.
- About $40 million to Cyanvac of Athens, Georgia, to advance its intranasal vaccine candidate, CVXGA.
Castlevax and Cyanvac phase 2b trials are in partnership with BARDA's Clinical Studies Network.