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1 1 (December 22, 2020)

handle is hein.crs/goveabo0001 and id is 1 raw text is: SCongressional *aResearch Service informing the legisIafive debate since 1914___________________ Operation Warp Speed Contracts for COVID-19 Vaccines and Ancillary Vaccination Materials December 22, 2020 Operation Warp Speed (OWS) is an interagency partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DOD) that coordinates federal efforts to accelerate the development, acquisition, and distribution of COVID-19 medical countermeasures. Collaborating HHS components include the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA). Although the stated goals of OWS include therapeutics and diagnostics, most of the money awarded to date has focused on vaccines. This Insight summarizes OWS's vaccine-related contracts, including those for ancillary vaccination materials (e.g., needles and vials). BARDA is currently supporting seven vaccine candidates through funding research and development, funding increases in manufacturing capacity, and/or advance purchase contracts. Of these candidates, only six are also being supported by OWS (Merck/IAVI is supported by BARDA, but not OWS). Table 1 provides information regarding these contracts, as well as details regarding the vaccine candidates themselves, including storage temperature, technology type, and preliminary effectiveness. OWS has invested in multiple candidates and different underlying technologies to protect against the risk of one or more vaccine candidates failing to demonstrate safety or efficacy at any point in the development process. Vaccine development, like drug development, in general, is typically an expensive process that takes 10 or more years. To speed up the vaccine development process, OWS implemented a number of measures. One measure, as stated by HHS, is that OWS supported increased manufacturing capacity for some of the vaccine candidates while they were still being tested, rather than the normal practice of waiting to scale- up until testing is complete. This is considered at-risk, in that the government is paying to build facilities to manufacture a vaccine candidate that might not prove to be safe or effective. Vaccine candidates that received support from the federal government for vaccine development include Moderna, Janssen Pharmaceuticals, Sanofi/GSK, and Merck/IAVI, whereas the other three candidates participated in OWS through federal purchase of vaccine doses only. Production of vaccine doses simultaneously with safety and efficacy testing has helped ensure that vaccine doses are ready to deploy as soon as they have been approved for use by the Food and Drug Administration (FDA). The Pfizer/BioNTech vaccine received Emergency Use Authorization (EUA) from the FDA on December 11, 2020, and the Modema Congressional Research Service https://crsreports.congress.gov IN11560 CRS INSIGHT Prepared for Members and Committees of Congress

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