- The Department of Health and Human Services is investing more than $1.4 billion in developing next-generation vaccines and therapeutics against COVID-19.
- This first round of funding through the $5 billion Project NextGen program supports development of more effective and longer lasting vaccines, a new monoclonal antibody, and streamlined biomanufacturing.
- Funding includes $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody, and $100 million to explore novel vaccine and therapeutic technologies
The Biden Administration today announced that it is allocating more than $1.4 billion to support the development of a new generation of tools and technologies to protect against COVID-19.
Project NextGen, a $5 billion initiative administered by the Biomedical Advanced Research and Development Authority (BARDA), coordinates across the federal government and the private sector to advance innovative vaccines and therapeutics into clinical trials, regulatory review, and potential commercial availability for the American people. The project builds on a better understanding of COVID-19 – developing, using, and constantly re-evaluating the strengths and weaknesses of current vaccines and therapeutics for over three years.
As the virus continues to evolve, we need new tools that keep pace with those changes, Project NextGen combines the research and development expertise at HHS with the lessons we have learned about the virus throughout the pandemic – strengthening our preparedness for whatever comes next.Dawn O’Connell, Assistant Secretary for Preparedness and Response
The awards announced today 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 for COVID-19 prevention.
- $100 million to Global Health Investment Corp. (GHIC), 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 (JLABS) for a competition through Blue Knight, a BARDA-JLABS partnership.
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. The public can expect to see clinical trials for new vaccine candidates targeting longer-lasting protection against future variants as early as this winter under Project NextGen.
HHS’ partnership with Regeneron is advancing its efforts to prevent COVID-19 infections by developing a novel monoclonal antibody 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 that the new monoclonal antibody will enter clinical trials this fall.
The remaining 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.
In parallel with the awards announced today, HHS continues to engage with potential partners and expects to announce additional awards before the end of this fiscal year.