Project NextGen Selects Initial Vaccine Candidates and Awards ... - HHS.gov

Vaccine selection brings products closer to clinical trials slated to begin as early as this winter

Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), is announcing the selection of initial next-generation vaccine candidates and more than $500 million in awards for Project NextGen – kick-starting planning for Phase 2b clinical trials and technologies that advance innovative next-generation vaccine and therapeutics platforms.

“The Biden-Harris Administration is committed to keeping people safe from COVID-19,” said HHS Secretary Xavier Becerra. “By investing in next-generation vaccines and treatments, we can improve our ability to respond to new variants, reduce transmission, stop infections, and save lives. Through Project NextGen, we are combining research and development expertise at HHS with the lessons learned throughout the pandemic to protect our nation from COVID-19.”

The over $500 million announced today builds on the over $1.4 billion awarded in August – accelerating products toward clinical trials and potential commercial availability.

“The vaccine selections and funding announced today are important steps forward for Project NextGen – with vaccine and therapeutics candidates moving quickly to clinical trials that will start in the coming months,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “The technologies that BARDA is investing in, from intranasal vaccines to self-amplifying mRNA, will bolster our protection against COVID-19 for years to come.”

All three next-generation vaccine selections announced today are distinct from each other, targeting stronger, broader, or longer-lasting immune responses. Intranasal vaccines have the potential to stop viruses at the site of infection and self-amplifying mRNA and additional antigens may generate a stronger immune response than current vaccine technologies. The awards announced today will support companies as they prepare their vaccine candidates for Phase 2b clinical evaluation:

$8.5 million to CastleVax for a vector-based intranasal vaccine candidate.
$10 million to Codagenix for a live-attenuated intranasal vaccine candidate.
$10 million to Gritstone Bio for a self-amplifying mRNA vaccine candidate.

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To support these and all future Project NextGen clinical studies, BARDA is awarding over $240 million, including investments in cold-chain sample management, genomic sequencing, and increased central laboratory capacity for sample testing:

$87 million to American Type Culture Collection (ATCC) to provide cold-chain and specimen lifecycle management.
$4 million to BioInfoExperts to provide genomic sequencing of COVID-19.
$23.2 million to Meso Scale Diagnostics (MSD) to develop and manufacture multiplexed COVID-19 antibody test kits.
$126.5 million to PPD to provide a central laboratory capacity that analyzes immune responses from samples collected during Project NextGen vaccine clinical trials.

Finally, BARDA is awarding over $241 million to support new technologies that will improve national preparedness for future COVID-19 outbreaks and patient access. These technologies have the potential to enable shorter development timelines for monoclonal antibodies through mRNA, increased efficiency in virus testing, and alternate routes for vaccine administration:

$40 million to Vir Biotechnology to support the development of mRNA-expressed monoclonal antibodies.
$100 million to Luminary Labs to administer two competitions focused on incentivizing the development of patches for vaccine delivery and reducing the number of vaccine doses needed for an effective immune response.
$59 million to ModeX Therapeutics to develop a monoclonal antibody for COVID-19 pre-exposure prophylaxis that can bind to multiple sites on the virus.
$10.5 million to Charles Stark Draper Laboratory (Draper Labs) to advance the development of tissue chip platform technology.
$6.1 million to Battelle and $5.8 million to the UK Health Security Agency to advance human lung and airway tissue chip platform technology.
$20 million to Evidation to test the use of commercial wearables for early respiratory illness detection and a home specimen sampling capability.