The US Department of Health and Human Services (HHS) today announced more than $500 million more in funding through its Project NextGen program to speed the development of new vaccines and treatments for COVID-19. The funding, through the Administration for Strategic Planning and Response (ASPR), includes three next-generation vaccines and allows the developers to more quickly start phase 2 clinical trials.
Dawn O’Connell, JD, assistant secretary for preparedness and response at HHS, said in a statement, "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."
First announced in April, Project NextGen is a $5 billion federal effort to speed the development of new COVID vaccines and treatments. Today’s announcement comes on top of $1.4 billion in countermeasure awards announced in August.
Vaccines include 2 intranasal, 1 self-amplifying mRNA
HHS said the three vaccine candidates are distinct from each other and target stronger, broader, or longer-lasting immune responses.
Scientists and public health experts have been pushing for better COVID vaccines, including ones that provide broader protection against a range of coronaviruses and ones that can cut transmission and symptoms. Early this year, a group led by the Center for Infectious Disease Research and Policy, which publishes CIDRAP News, published a roadmap for advancing better vaccines against coronaviruses.
HHS said intranasal vaccines have the potential to stop viruses at the infection site, and vaccines containing self-amplifying mRNA (samRNA) and additional antigens may prompt a stronger immune response than current vaccines.
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.
One of the candidate vaccines is a live-attenuated intranasal vaccine from Codagenix, which announced initial phase 1 clinical trial findings earlier this week. Another is a vector-based intranasal vaccine from CastleVax, a research and development arm of Mount Sinai Health Systems, which announced promising initial phase 1 findings for its vaccine in July.
The third candidate vaccine is a samRNA vaccine from Gritstone Bio, which is slated to detail promising results from three ongoing phase 1 clinical trials this week at the ID Week meeting in Boston. In a press release this week, Andrew Allen, MD, PhD, the company’s chief executive officer, said, "These data reaffirm previous findings that our samRNA vaccines have the potential to drive highly durable antibody responses, to enhance immunity through broader T cell responses, and to accomplish this at RNA doses as low as 3 micrograms, one tenth the dose of currently approved mRNA vaccines for COVID-19."
Support for clinical trials, treatments, vaccine access
HHS also announced $240 million in funding to four companies to support vaccine clinical studies and to improve sampling, from cold-chain management to increasing central lab capacity.
It also awarded about $241 million to six companies to boost preparedness for future COVID outbreaks and to improve access to treatment, such as shortening the development timeline for mRNA-expressed monoclonal antibodies and advancing the development of vaccine patches.
HHS Secretary Xavier Becerra, JD, said the investments signal the Biden-Harris administration’s commitment to keeping people safe from COVID. "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."
