The U.S. Department of Health and Human Services (HHS) has awarded $1.4 billion to support vaccine clinical trials to test new, more effective and longer-lasting COVID-19 vaccines. In all, Project NextGen is a $5 billion initiative from Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).
The aim of the program is to identify and address strengths and weaknesses of current COVID-19 therapies and vaccines, as well as the back the development of next-gen COVID-19 vaccines and therapies
The latest funding announcement announced allots $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody and another $100 million to spark innovation of novel vaccine and therapeutic technologies.
Towards next-gen COVID-19 vaccines and therapies
Regeneron alone received $326 million under the program, dubbed Project NextGen. The funding for the Tarrytown, New York–based company will cover the development of a next-generation monoclonal antibody for COVID-19 prevention.
In the throes of the pandemic, Regeneron was quick to win authorization for its monoclonal antibody cocktail, REGN-COV2, winning emergency use authorization on November 21, 2020. While the FDA authorized its use for mild to moderate COVID-19 infections, the agency recommended pulling it from the market after it proved ineffective against omicron.
Part of the remaining circa $1 billion of the funding will support four BARDA clinical trial partners with plans for phase IIb clinical trial studies of new COVID-19 vaccines.
Recipients of the funding include ICON Government and Public Health Solutions, Pharm-Olam, Technical Resources International (TRI) and Rho Federal Systems.
In addition, $100 million will go to Global Health Investment Corp. (GHIC) to explore improved strategies for pandemic responses.
Another $10 million will go to BLUE KNIGHT, a collaboration between BARDA and Johnson & Johnson Innovation. The project will prioritize the development of novel strategies for emergency preparedness and response related to emerging infectious disease threats.
HHS plans to work with potential partners and announce additional award recipients before the end of this fiscal year.