Report to congressional addressees.
"Why GAO Did This Study
... GAO was asked to review OWS [Operation Warp Speed] vaccine development efforts. This report examines: (1) the characteristics and status of the OWS vaccines, (2) how developmental processes have been adapted to meet OWS timelines, and (3) the challenges that companies have faced with scaling up manufacturing and the steps they are taking to address those challenges...
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). 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)...
Technology readiness... FDA issued specific guidance that identified ways that vaccine development may be accelerated during the pandemic. Vaccine companies told GAO that the primary difference from a non-pandemic environment was the compressed timelines. To meet OWS timelines, some vaccine companies relied on data from other vaccines using the same platforms, where available, or conducted certain animal studies at the same time as clinical trials... The two EUAs issued in December 2020 were based on analyses of clinical trial participants and showed about 95 percent efficacy for each vaccine. These analyses included assessments of efficacy after individuals were given two doses of vaccine and after they were monitored for about 2 months for adverse events.
Manufacturing... DOD and HHS are working with vaccine companies to help mitigate manufacturing challenges...
As part of the U.S. vaccine effort, on May 15, 2020, the federal government announced Operation Warp Speed (OWS), a partnership between the Department of Defense (DOD) and Department of Health and Human Services (HHS). As stated on the HHS website, the goal was to produce 300 million doses of COVID-19 vaccines, with initial doses available by January 2021. Although FDA has authorized two vaccines for emergency use, OWS has not yet met its production goals. Our November 2020 report included the following figure describing how the federal government aimed to accelerate the development of a COVID-19 vaccine (see fig. 1). DOD and HHS have obligated approximately $13 billion as of December 31, 2020, to support the development, manufacture, and distribution of vaccines to help achieve this goal...
Background
... HHS and DOD, in support of OWS, awarded contracts and other transaction agreements to six vaccine companies to develop or manufacture vaccine doses."
This is a work of the U.S. government and is not subject to copyright protection in the United States. The published product may be reproduced and distributed in its entirety without further permission from GAO.