In April, the White House launched a $5 billion program, Project NextGen, to accelerate the development of vaccines and treatments for Covid-19. Project NextGen has some similarities to Operation Warp Speed, the Trump administration’s program to speed the development and deployment of the original Covid-19 vaccines. While many details of Project Next Gen still remain unannounced, there are several ways the program differs from the Trump-era predecessor.
Target products — and challenge trials?
Operation Warp Speed was focused almost entirely on producing vaccines for Covid-19, but Project NextGen will focus on three areas: monoclonal antibodies, universal coronavirus vaccines, and intranasal/mucosal vaccines.
The initial vaccines produced by Pfizer-BioNTech, Moderna, Jansse/Johnson & Johnson, and Oxford-AstraZeneca were extremely effective at preventing severe illness and death. As SARS-CoV-2 has evolved, however, boosters have become necessary. A universal coronavirus vaccine targeting coronaviruses that cause disease in humans besides Covid-19 (like MERS and SARS-1) would very likely also protect against any future variant of Covid-19, making it an especially attractive option.
According to USA Today, these three goals were in part based on recommendations from the Center for Infectious Disease Research and Policy (CIDRAP) report from February 2023, A Research and Development (R&D) Roadmap for Broadly Protective Coronavirus Vaccines. Notably, that report also calls for concerted discussion on the use of human challenge studies (or controlled human infection models, CHIMs). Several high-priority recommendations in the report call for standardizing the use of coronavirus human challenge studies.
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It remains to be seen how Project NextGen will influence human challenge model development in the field.
Public-private partnership and federal structure
Just like Operation Warp Speed, Project NextGen will likely rely on the private sector to develop and manufacture vaccines, though Project NextGen has yet to identify specific private partners.
Operation Warp Speed involved a very large swathe of the government, including the Department of Health & Human Services, but also the FDA — to coordinate regulatory approvals — and even the Department of Defense to assist with logistics. Project NextGen will be based in Health & Human Services, but its other federal implementing partners are not yet clear.
Project NextGen is to be funded through excess from the Health & Human Services budget, initially $5 billion. While significant, this may not be enough to get each of the target products over the line quickly. Operation Warp Speed involved roughly $18 billion for its vaccine development efforts.
It is not clear how Project NextGen funding will be deployed. Operation Warp Speed provided both “push” and “pull” funding — direct grants to support ongoing research to “push” development and and purchase agreements (advance market commitments) to guarantee a market for successful products, “pulling” development along with it.