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1 1 (December 15, 2020)

handle is hein.crs/govddao0001 and id is 1 raw text is: SConr essional Research Servik Funding for COVID-19 Vaccines: An Overview December 15, 2020 On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer/BioNTech's Coronavirus Disease 2019 (COVID-19) vaccine. Several other COVID-19 vaccines are currently in clinical trials or under review; additional vaccines may become available by the end of 2020. Moderna has announced preliminary Phase 3 results and is under EUA consideration. As a part of Operation Warp Speed (OWS)-the Trump Administration's COVID-19 medical countermeasure initiative led by the Department of Health and Human Services (HHS) and the Department of Defense (DOD)-the U.S. government has entered into several contracts with vaccine manufacturers to purchase hundreds of millions of doses (including Pfizer/BioNTech and Moderna's vaccine) and has also supported manufacturing and procurement of related supplies. Other OWS vaccine efforts include planning and implementation of a nationwide immunization program, public awareness, and vaccine data tracking, among others. OWS has thus far been financed largely by emergency funding provided in the coronavirus supplemental appropriations acts. To date, not much supplemental funding has been appropriated specifically for COVID-19 vaccine-related efforts. Instead, funding has been provided to several accounts that may be used toward relevant activities. Much of the HHS supplemental funding is available for multiple years or until expended. In addition, HHS transfer authorities in the laws allow for transfers between funds in certain HHS accounts. This Insight provides overviews of such appropriations for selected vaccine-related activities and available information on allocations and obligations. It does not address health care financing issues related to vaccine administration. As Congress considers regular FY2021 discretionary appropriations and potential additional emergency appropriations, it may consider whether to provide additional vaccine-related appropriations. Vaccine Research and Development, Manufacturing, and Purchase COVID-19 vaccine research and development (R&D), manufacturing, and purchasing efforts are largely supported by OWS, which represents a collaboration among several federal agencies, including the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), DOD, and others. As of October 29, 2020, OWS was supporting eight investigational vaccines, with six contractual partnerships announced. The terms of the contracts vary by vaccine, but Congressional Research Service https://crsreports.congress. gov IN11556 CRS INS GHT Prepared for Members and Cornnmttees oi Conqres3--------------------------------------------------------------------------

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