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. Vaccine companies told GAO that the primary difference from a non-pandemic environment was the compressed timelines.
FDA issued specific guidance that identified ways that vaccine development may be accelerated during the pandemic. GAO's analysis of the OWS vaccine candidates' technology readiness levels (TRL)-an indicator of technology maturity- showed that COVID-19 vaccine development under OWS generally followed traditional practices, with some adaptations. For vaccines that received EUA, additional data on vaccine effectiveness will be generated from further follow-up of participants in clinical trials already underway before the EUA was issued. Vaccine Platform Technologies Supported by Operation Warp Speed, as of January 2021Īs of January 30, 2021, five of the six OWS vaccine candidates have entered phase 3 clinical trials, two of which-Moderna's and Pfizer/BioNTech's vaccines-have received an emergency use authorization (EUA) from the Food and Drug Administration (FDA). 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).
WARP SPEED VACCINE TRIAL
Vaccine companies also took steps, such as starting large-scale manufacturing during clinical trials and combining clinical trial phases or running them concurrently. For example, OWS selected vaccine candidates that use different mechanisms to stimulate an immune response (i.e., platform technologies see figure). GAO found that OWS and vaccine companies adopted several strategies to accelerate vaccine development and mitigate risk. 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.
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