United States Government Accountability Office Report to Congressional Addressees April 2021 COVID-19 Efforts to Increase Vaccine Availability and Perspectives on Initial Implementation GAO-21-443 April 2021 COVID-19 Efforts to Increase Vaccine Availability and Perspectives on Initial Implementation Highlights of GAO-21-443, a report to congressional addressees Why GAO Did This Study What GAO Found Providing the public with safe and The federal government has taken several actions to increase the availability of effective vaccines to prevent COVID- COVID-19 vaccine doses and indicated it expects to have enough doses 19 is crucial to mitigating the public available for all adults in the United States by the end of May. As of April 1, 2021, health and economic impacts of the the government had purchased 1.2 billion doses of one- and two-dose regimen disease. The U.S. had almost 30 vaccines. Also, vaccine companies reported making additional manufacturing million reported cases and over sites operational, among other actions to expand capacity and mitigate 545,000 reported deaths as of March challenges. 27, 2021. The federal government took a critical step in December 2020 in Federal officials said projecting future availability of vaccine doses can be authorizing the first two COVID-19 difficult, in part because of uncertainty surrounding complex manufacturing vaccines and beginning distribution of processes. Given this uncertainty, coupled with the significant manufacturing and doses across the nation. The distribution increases needed to have enough vaccine doses available for all government had distributed about adults, managing public expectations is critical. GAO’s prior work has found that 180.6 million vaccine doses, and about timely, clear, and consistent communication about vaccine availability is essential 147.8 million doses had been to ensure public confidence and trust, especially as initial vaccine implementation administered, as of March 27, 2021, did not match expectations. according to Centers for Disease Control and Prevention (CDC) data. COVID-19 Vaccination Site The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines, among other issues, actions the federal government has taken to increase the availability of COVID-19 vaccine doses, and challenges with initial vaccine implementation—that is, prioritizing, allocating, distributing, and administering vaccine doses— identified by stakeholders and steps the federal government has taken to improve vaccine implementation. GAO reviewed documents from the Departments of Defense and Health and Human Services, transcripts of public briefings, data from CDC, and interviewed or received written Stakeholders GAO interviewed identified challenges with initial COVID-19 responses from federal officials, vaccine implementation. For example, some stakeholders said states often did vaccine company representatives, and not have information critical to distribution at the local level, such as how many select public health stakeholders. GAO doses they would receive and when. The federal government has begun incorporated technical comments from initiatives—outlined in a national response strategy—to improve implementation, the Department of Defense, the such as creating new vaccination sites. In its March 2021 distribution strategy, Department of Health and Human CDC provided a high-level description of its activities and noted that more details Services, and the Federal Emergency would be included in future reports to Congress. To meet the expectations set by Management Agency as appropriate. recent announcements, such as the planned expansion of vaccine eligibility to all View GAO-21-443. For more information, adults and the introduction of tools to help individuals find vaccines, it will be contact Alyssa M. Hundrup at (202) 512-7114 imperative that the federal government effectively coordinate and communicate or [email protected]. its plans, as GAO recommended in September 2020. United States Government Accountability Office Contents Letter 1 Background 6 The Federal Government’s Contracting Approach Aimed to Accelerate Vaccine Development and Manufacturing While Mitigating Cost Risk to the Government 16 The Federal Government Has Purchased Additional Vaccine Doses and Helped Mitigate Manufacturing Challenges to Increase Vaccine Availability 24 Stakeholders Identified Challenges with Initial COVID-19 Vaccination; the Federal Government Has Taken Some Steps to Help Improve Vaccine Implementation 32 Agency Comments 44 Appendix I GAO Contact and Staff Acknowledgments 47 Related GAO Products 48 Tables Table 1: Status of Six COVID-19 Vaccine Candidates under the DOD and HHS Partnership, as of March 27, 2021 8 Table 2: Manufacturing Partners for the Six COVID-19 Vaccine Candidates under the DOD and HHS Partnership, as of March 2021 9 Table 3: Summary of Selected Payment and Termination Terms and Conditions Contained in the Production Awards for the Six Operation Warp Speed Vaccine Candidates, July 2020-November 2020 19 Table 4: Contracted Amount of COVID-19 Vaccine Doses under the Department of Defense (DOD) and Department of Health and Human Services (HHS) Partnership, by Vaccine Company, as of April 1, 2021 24 Table 5: Status of Manufacturing Capacity Expansion Efforts for Six COVID-19 Vaccine Candidates under the DOD and HHS Partnership, as of March 2021 29 Table 6: Examples of Challenges with Initial COVID-19 Vaccine Implementation Reported by Stakeholders, as of February 1, 2021 33 Page i GAO-21-443 COVID-19 Vaccines Table 7: Changes by the Federal Government to the Initial COVID-19 Vaccine Implementation between November 2020 and mid-February 2021 35 Figures Figure 1: Department of Defense (DOD) and Department of Health and Human Services (HHS) Obligations for COVID-19 Vaccine Candidates under the DOD and HHS Partnership, as of March 14, 2021 7 Figure 2: Potential Choke Points in Scaling Up Vaccine Production Related to Key Manufacturing Challenges 11 Figure 3: Daily Count of Doses of COVID-19 Vaccine Administered and Reported to CDC as of March 27, 2021 15 Figure 4: Number of Doses of COVID-19 Vaccine Released in the U.S. per Week (in millions), as of March 29, 2021 26 Figure 5: Number of Vaccine Doses Distributed in the U.S. per Week, as of March 27, 2021 30 Abbreviations ACIP Advisory Committee on Immunization Practices CDC Centers for Disease Control and Prevention COVID-19 Coronavirus Disease 2019 DOD Department of Defense EUA emergency use authorization FDA Food and Drug Administration FEMA Federal Emergency Management Agency HHS Department of Health and Human Services National Strategy National Strategy for the COVID-19 Response and Pandemic Preparedness 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. However, because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately. Page ii GAO-21-443 COVID-19 Vaccines Letter 441 G St. N.W. Washington, DC 20548 April 14, 2021 Congressional Addressees Providing the public with safe and effective vaccines to prevent Coronavirus Disease 2019 (COVID-19) is crucial to mitigating the public health and economic impacts of the disease and ending the pandemic. There have been almost 30 million reported cases of COVID-19 and over 545,000 reported deaths in the United States as of March 27, 2021.1 Given this catastrophic loss of life and the pandemic’s devastating effects on the U.S. economy, as well as new potentially harmful variants of SARS-CoV-2, the virus that causes COVID-19, vaccines are essential for preventing COVID-19 and related serious outcomes, such as hospitalization or death. In December 2020, the United States took an important step to protect the public against COVID-19 as the first COVID-19 vaccines—developed in a shorter time than any previous vaccine—were authorized for emergency use and administered.2 With three COVID-19 vaccines now authorized for emergency use as of March 27, 2021, more than 91.7 million people had received at least one vaccine dose and more than 50.1 1Data on COVID-19 cases in the U.S. are based on aggregate case reporting to the Centers for Disease Control and Prevention (CDC) and include probable and confirmed cases as reported by states and jurisdictions. CDC COVID-19 counts are subject to change due to delays or updates in reported data from states and territories. According to CDC, the actual number of COVID-19 cases is unknown for a variety of reasons, including that people who have been infected may have not been tested or may not have sought medical care. CDC’s National Center for Health Statistics COVID-19 death counts in the U.S. are based on provisional counts from death certificate data, which do not distinguish between laboratory-confirmed and probable COVID-19 deaths. Provisional counts are incomplete due to an average delay of 2 weeks (a range of 1–8 weeks or longer) for death certificate processing. 2For more information on the accelerated COVID-19 vaccine development process, see GAO, Operation Warp Speed: Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges. GAO-21-319, (Washington, D.C.: Feb. 11, 2021). GAO has also produced an interactive dashboard that integrates