$1.4 Billion for NextGen COVID-19 Vaccines and Therapeutics

The U.S. Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), today announced it awarded more than $1.4 billion for Project NextGen.

This award supports the development of a new generation of tools and technologies to protect people against COVID-19 for years to come.

Project NextGen, a $5 billion initiative led by ASPR’s Biomedical Advanced Research and Development Authority (BARDA) in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), coordinates across the federal government and the private sector to advance innovative COVID-19 vaccines and therapeutics into clinical trials, regulatory review, and potential commercial availability for the American people.

The awards announced on August 22, 2023, include the following actions:

$1 billion to four BARDA Clinical Trial partners to support vaccine Phase IIb clinical trial studies: ICON Government and Public Health Solutions, Inc of Hinckley, Ohio; Pharm-Olam, LLC, of Houston, Texas; Technical Resources Intl (TRI), Inc, of Bethesda, Maryland; and Rho Federal Systems, Inc., Durham, North Carolina.

$326 million to Regeneron to support the development of a next-generation monoclonal antibody (mAb) for COVID-19 prevention.

$100 million to Global Health Investment Corp., the non-profit organization managing the BARDA Ventures investment portfolio, to expand investments in new technologies that will accelerate responses in the future.

$10 million to Johnson & Johnson Innovation for competition through Blue Knight, a BARDA-JLABS partnership.

“Project NextGen is a key part of the U.S. Administration’s commitment to keeping people safe from COVID-19 variants,” commented HHS Secretary Xavier Becerra in a related press release.

“These awards are a catalyst for the program – kickstarting efforts to more quickly develop vaccines and continue to ensure availability of effective treatments.”

The awards to BARDA’s Clinical Studies Network will speed the development of new vaccine candidates, providing a network of at-the-ready trials with the flexibility to pivot to the most promising new vaccines as they mature.

HHS’ partnership with Regeneron is advancing its efforts to prevent COVID-19 infections by developing a novel mAb that will protect people who do not respond to or cannot take existing vaccines – a critical need and current gap in COVID-19 therapeutics.

HHS and Regeneron expect the new mAb to enter clinical trials in the fall 0f 2023.

The remaining NextGen awards will fund technologies that enable more efficient development and manufacturing strategies – accelerating development timelines across the board and bolstering future vaccine and therapeutic availability.