BARDA awards up to $500 million in Project NextGen funding for vaccine clinical trials

Project awards made under new Rapid Response Partnership Vehicle will evaluate novel COVID-19 vaccine candidates

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.

“We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises. That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness,” said HHS Secretary Xavier Becerra. “We are making progress on the development of cutting-edge treatments, such as vaccines administered as a nasal spray or as a pill. The Biden-Harris Administration won’t stop until we have the next generation of innovative vaccines, therapeutics, and other tools to protect against COVID-19, or any other pathogen that could threaten the American public.”

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.

“At ASPR, we are working to unlock technology that will better protect Americans from viruses like COVID-19,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “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.”

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. Successful development of intranasal and oral vaccines would provide safe, effective, needle-free vaccines that are easier-to-administer options with the potential to improve vaccine access.

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 announced today 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. Visit the Project NextGen portfolio page to learn more.