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1 1 (February 25, 2021)

handle is hein.crs/goveciw0001 and id is 1 raw text is: - Congressional .Research Service Informing the legislative debate since 1914 Operation Warp Speed Contracts for COVID-19 Vaccines and Ancillary Vaccination Materials Updated February 25, 2021 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). OWS is a Trump Administration initiative, and while the Biden Administration has indicated that the interagency response to COVID-19 will continue, it plans to restructure and rename the effort. 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 six vaccine candidates through funding research and development, funding increases in manufacturing capacity, and/or advance purchase contracts. A vaccine candidate from Merck/IAVI also received funding support from BARDA, but was discontinued in January 2021 because it failed to demonstrate sufficient efficacy against COVID-19. Table 1 provides BARDA contract awards and additional information about these candidates. Vaccine development, like drug development, is generally an expensive process that takes 10 or more years. To accelerate development, OWS implemented a number of measures, including supporting increased manufacturing capacity for some of the vaccine candidates while they were still in testing, rather than waiting until testing was complete to scale up production. This investment is considered at- risk, in that the federal government is paying to develop or manufacture vaccine candidates that may not prove to be safe or effective. Vaccine candidates that received federal government support for development include Moderna, Janssen Pharmaceuticals, Sanofi/GSK, and Merck/IAVI (see Table 1), whereas the Pfizer/BioNTech, Janssen, and Novavax candidates participated in OWS through federal purchase of doses only. Two manufacturers have received Emergency Use Authorization (EUA) from the Food and Drug Administration for their Congressional Research Service https://crsreports.congress.gov IN11560 CRS INSIGHT Prepared for Members and Committees of Congress

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