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Over $1.4 billion awarded for COVID-19 vaccine clinical trials and therapeutics

Project NextGen funding includes $1B for clinical trials, $326M for a new monoclonal antibody and $100M for novel vaccines and therapeutics.

Susan Morse, Executive Editor

Photo: Longhua Liao/Getty Images

The federal government is releasing $1.4 billion to support clinical trials, coronavirus antibodies and what the Department of Health and Human Services is calling transformative technologies to fight COVID-19. 

HHS, through the Administration for Strategic Preparedness and Response, has awarded the more than $1.4 billion through Project NextGen, a $5 billion initiative led by the Biomedical Advanced Research and Development Authority (BARDA) in partnership with the National Institute of Allergy and Infectious Diseases.

The awards 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. HHS and Regeneron expect that the new monoclonal antibody will enter clinical trials this fall.
  • $100 million to Global Health Investment Corp. (GHIC), the nonprofit 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 support clinical trials that will enable the rapid development of even more effective and longer-lasting coronavirus vaccines, a new monoclonal antibody and transformative technologies to streamline the manufacturing processes, according to HHS.

WHY THIS MATTERS

The public can expect to see clinical trials for new vaccine candidates targeting longer-lasting protection against future variants as early as this winter, according to HHS.

"Project NextGen is a key part of the Biden-Harris Administration's commitment to keeping people safe from COVID-19 variants," said HHS Secretary Xavier Becerra. "These awards are a catalyst for the program – kickstarting efforts to more quickly develop vaccines and continue to ensure availability of effective treatments."

The project builds on a better understanding of COVID-19 – with HHS developing, using and constantly reevaluating the strengths and weaknesses of current vaccines and therapeutics for more than three years.

"As the virus continues to evolve, we need new tools that keep pace with those changes," said Assistant Secretary for Preparedness and Response Dawn O'Connell. "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."

THE LARGER TREND
 
Project NextGen coordinates across the federal government and the private sector to advance innovative vaccines and therapeutics into clinical trials, regulatory review and potential commercial availability. 

The awards follow coordination with industry partners.

HHS said it continues to engage with potential partners and expects to announce additional awards before the end of this fiscal year.

Twitter: @SusanJMorse
Email the writer: SMorse@himss.org