$500 Million Awarded to Newer COVID-19 Vaccines

The U.S. Biomedical Advanced Research and Development Authority (BARDA) today announced up to $500 million in Project NextGen funding for multiple Phase 2b clinical trials to evaluate novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.

While currently approved COVID-19 vaccines are administered intramuscularly, they are limited in their capacity to induce a robust immune response in mucosal areas such as the mouth, nose, and gut, where the SARS-CoV-2 coronavirus first enters people.

Successful development of intranasal and oral vaccines would provide safe, effective, needle-free, easier-to-administer options with the potential to improve vaccine access.

“We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises. That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness,” U.S. HHS Secretary Xavier Becerra said in a press release on June 13, 2024. 

The project awards were made to:

Up to $453 million to Vaxart of San Francisco, California, developing an oral pill vaccine candidate, adenovirus serotype 5. BARDA will provide an initial $65.7 million for early trial milestones, with remaining funds provided as the effort successfully advances toward trial execution. Vaxart will execute its own Phase 2b clinical trials.

Approximately $34 million was donated to Castlevax, part of the Mount Sinai Health System in New York City, to develop an intranasal vaccine candidate, CVAX-01.    

Approximately $40 million will go to Cyanvac of Athens, Georgia, to develop an intranasal vaccine candidate, CVXGA. 

Castlevax and Cyanvac Phase 2b trials are in partnership with BARDA’s Clinical Studies Network.

These awards are just one component of BARDA’s Project NextGen medical countermeasures portfolio. To date, BARDA has leveraged more than $2 billion in Project NextGen funding to support the development of next-generation vaccines, treatments, and enabling technologies. 

As of June 14, 2024, the U.S. government has approved three COVID-19 vaccines, while the World Health Organization has qualified 13 vaccines.