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), has announced up to $500 million in Project NextGen funding. This funding aims to plan and execute multiple Phase 2b clinical trials evaluating novel vaccines administered as a nasal spray or 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) and will support several companies in preparing vaccine candidates for Phase 2b clinical trials:
- Up to $453 million will be allocated to Vaxart of San Francisco, California, which is developing an oral pill vaccine candidate using adenovirus serotype 5 (Ad-5). An initial $65.7 million will be provided for early trial milestones, with remaining funds contingent on successful advancement toward trial execution.
- Approximately $34 million will go to Castlevax, part of the Mount Sinai Health System in New York City, which is developing an intranasal vaccine candidate named CVAX-01.
- Approximately $40 million will be awarded to Cyanvac of Athens, Georgia, which is developing an intranasal vaccine candidate called CVXGA.
Castlevax and Cyanvac's Phase 2b trials are being conducted 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 are effective but limited in inducing a robust immune response in mucosal areas such as the mouth, nose, and gut where SARS-CoV-2 first enters the body. The development of intranasal and oral vaccines aims to provide safe, effective needle-free options that could improve vaccine access.
Each of these three Phase 2b clinical trials will recruit 10,000 volunteers. Half will receive one of the investigational vaccines while the other half receives an FDA-licensed vaccine. The efficacy and safety of these investigational vaccines will be compared with licensed ones.
BARDA established its Clinical Studies Network in 2012 to assist private sector partners with technical and regulatory guidance in developing medical countermeasures against various threats including pandemic influenza and emerging infectious diseases. The RRPV is designed as a multi-purpose acquisition vehicle supporting advanced research into medical countermeasures like vaccines.
Project NextGen is a $5 billion initiative led by BARDA alongside the National Institute of Allergy and Infectious Diseases aimed at accelerating innovative COVID-19 solutions. To date, over $2 billion has been leveraged through Project NextGen funding for developing next-generation vaccines and treatments.
These latest awards build on previous efforts including over $25 million allocated in May towards decentralized clinical trial solutions aiming at better data collection from diverse populations regarding COVID-19 vaccine protection correlates.
