Fast Facts Operation Warp Speed was a federal effort that supported multiple COVID-19 vaccine candidates to speed up development.
We analyzed the program's vaccine candidates and found that their development followed traditional practices, with some adaptations. For example, some clinical trial phases overlapped with each other and with animal studies to accelerate development. Two vaccines were authorized for emergency use—our tracker shows all the candidates.
We also found that agencies are working to help mitigate vaccine manufacturing challenges. For example, agencies have taken steps to require contractors to prioritize vaccine production supplies.
Highlights What GAO Found
Operation Warp Speed (OWS)—a partnership between the Departments of Health and Human Services (HHS) and Defense (DOD)—aimed to help accelerate the development of a COVID-19 vaccine. GAO found that OWS and vaccine companies adopted several strategies to accelerate vaccine development and mitigate risk. For example, OWS selected vaccine candidates that use different mechanisms to stimulate an immune response (i.e., platform technologies; see figure). Vaccine companies also took steps, such as starting large-scale manufacturing during clinical trials and combining clinical trial phases or running them concurrently. Clinical trials gather data on safety and efficacy, with more participants in each successive phase (e.g., phase 3 has more participants than phase 2).
Operation Warp Speed was a federal effort that supported multiple COVID-19 vaccine candidates to speed up development.
We analyzed the program's vaccine candidates and found that their development followed traditional practices, with some adaptations. For example, some clinical trial phases overlapped with each other and with animal studies to accelerate development. Two vaccines were authorized for emergency use—our tracker shows all the candidates.
We also found that agencies are working to help mitigate vaccine manufacturing challenges. For example, agencies have taken steps to require contractors to prioritize vaccine production supplies.
Highlights
What GAO Found
Operation Warp Speed (OWS)—a partnership between the Departments of Health and Human Services (HHS) and Defense (DOD)—aimed to help accelerate the development of a COVID-19 vaccine. GAO found that OWS and vaccine companies adopted several strategies to accelerate vaccine development and mitigate risk. For example, OWS selected vaccine candidates that use different mechanisms to stimulate an immune response (i.e., platform technologies; see figure). Vaccine companies also took steps, such as starting large-scale manufacturing during clinical trials and combining clinical trial phases or running them concurrently. Clinical trials gather data on safety and efficacy, with more participants in each successive phase (e.g., phase 3 has more participants than phase 2).
https://www.gao.gov/products/gao-21-319