BARDA Awards Up To $500 Million In Project NextGen Funding For Vaccine Clinical Trials
Government
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.
Currently approved COVID-19 vaccines are administered intramuscularly and, while extremely effective, are limited in their capacity to induce a robust immune response in mucosal areas such as the mouth, nose, and gut, where the SARS-CoV-2 virus first enters the body.
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.
BARDA established the Clinical Studies Network in 2012 to provide private sector partners with technical and regulatory assistance in the development of vaccines, therapeutics, diagnostics, and medical devices to prevent or treat the medical consequences of chemical, biological, radiological, and nuclear threats; pandemic influenza; and emerging infectious diseases. The RRPV is a 10-year, multi-purpose acquisition vehicle and consortium partnership designed to support advanced research and development of medical countermeasures, such as vaccines, therapeutics, and diagnostics.
Project NextGen is a $5 billion program led by BARDA and the National Institute of Allergy and Infectious Diseases to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. To date, BARDA has leveraged more than $2 billion in Project NextGen funding to support development of next generation vaccines, treatments, and enabling technologies. The awards also build on over $25 million awarded in May to support decentralized clinical trial solutions and to enable better COVID-19 vaccine correlates of protection data collection from larger and more diverse populations.
These awards are just one component of BARDA’s Project NextGen medical countermeasures portfolio.