BARDA awards $500M for Project NextGen vaccine trials
The trials will evaluate novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.
Photo: AlexandruPavalache/Getty Images
The Biomedical Advanced Research and Development Authority (BARDA) is setting aside 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.
BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services.
"We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises," said HHS Secretary Xavier Becerra. "That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness."
WHAT'S THE IMPACT?
The project awards were made through BARDA's Rapid Response Partnership Vehicle to support a number of companies.
Up to $453 million will go to Vaxart of San Francisco, California, for developing an oral pill vaccine candidate. 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.
About $34 million will go to Castlevax, part of the Mount Sinai Health System in New York City, which is developing an intranasal vaccine candidate, CVAX-01. And roughly $40 million is set to be awarded to Cyanvac of Athens, Georgia, which is developing another 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. While effective, they 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, according to HHS, 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 will receive an FDA-licensed vaccine. The efficacy and safety of the investigational vaccines will be compared to the licensed vaccines.
THE LARGER TREND
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. This was with an eye toward preventing or treating the medical consequences of chemical, biological, radiological and nuclear threats, pandemic influenza, and emerging infectious diseases.
The RRPV is a 10-year, multipurpose 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 COVID-19 vaccines, therapeutics and enablers. To date, BARDA has leveraged more than $2 billion in Project NextGen funding.
ON THE RECORD
"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."
Jeff Lagasse is editor of Healthcare Finance News.
Email: jlagasse@himss.org
Healthcare Finance News is a HIMSS Media publication.
