As of Sept., more than 700 unique clinical compounds were in development to treat or prevent infection or complications of COVID-19 disease. The U.S. government formed Operation Warp Speed, a public and private partnership to accelerate the development, manufacturing, and distribution of COVID-19 countermeasures.
Researchers sought to characterize U.S. government funding decisions for COVID-19 vaccines and treatments and compare characteristics of vaccine development programs and companies awarded acceleration grants. They found that key factors leading to U.S. government funding for COVID-19 vaccines and therapeutics included programs utilizing previously approved vaccine platforms, products being rapidly deployable, companies having significant domestic and global manufacturing capacity and scalability, and companies having established U.S. development and manufacturing supply chains.
The results of the study were presented during AMCP Nexus 2020 Virtual in a poster presentation titled “Assessment and Characterization of U.S. Government Funding Decisions for COVID-19 Vaccine and Treatment Development Programs and Manufacturing.”
Researchers gathered and reviewed funding documents from the Biomedical Advanced Research and Development Authority (BARDA), National Institutes of Health (NIH), and Department of Defense (DoD). The study comprised 188 vaccines, 198 antivirals, and 351 treatments.
BARDA and DoD funded nearly $12 billion in vaccine development and manufacturing and $992 million for therapeutics. Manufacturing awards were expected to produce up to 800 million doses of vaccines and between 70,000 and 300,000 doses of antibodies against COVID-19. Fifteen awards were given to eight manufacturers for vaccines, with an average award amount of $790 million.
Most of the COVID-19 vaccine funding (61%; $7.2 billion) was going toward manufacturing, while 12% ($1.4 billion) went toward clinical development, and 27% ($3.2 billion) was a mix of the two. The amount of funding for COVID-19 therapeutics was split between manufacturing (49%; $481 million) and a mix of manufacturing and clinical development (48%; $477 million).
The NIH has funded more than 1,000 projects totaling nearly $2 billion, with five strategic priorities:
- Improving knowledge on COVID-19
- Advancing research in detection
- Supporting treatment research
- Accelerating research for prevention
- Preventing poor outcomes by addressing vulnerable populations
Key attributes of vaccine programs included rapid and scalable manufacturing, domestic U.S. manufacturing, previously used or studied vaccine platforms, and ability to manufacture in parallel to conducting clinical trials. Key attributes of therapeutics programs included large scale manufacturing without needing human antibody donation, existing BARDA partnership, products previously approved or under review by the FDA, and rapidly deployable solutions.
“Operation Warp Speed funding was weighted heavily in manufacturing parallel to running clinical trials—this increases financial risk of the programs but aligned with the operation’s goal of having product ready for distribution if a vaccine candidate would be authorized for use,” the researchers concluded.
The study was sponsored by APPERTURE Health.
Quenelle CV, Lagudua R, Ambegaonkar A, Mohapatra S. Assessment and Characterization of U.S. Government Funding Decisions for COVID-19 Vaccine and Treatment Development Programs and Manufacturing. Poster B8. AMCP Nexus 2020 Virtual.