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Framework for Equitable Allocation of COVID-19 Vaccine Helene Gayle, William Foege, Lisa Brown, and Benjamin Kahn, Editors Committee on Equitable Allocation of Vaccine for the Novel Coronavirus Board on Health Sciences Policy Board on Population Health and Public Health Practice Health and Medicine Division PREPUBLICATION COPY: UNCORRECTED PROOFS

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by contracts between the National Academy of Sciences and the Centers for Disease Control and Prevention and the National Institutes of Health (75N98020F00007). This project has been funded in whole or in part with federal funds from the Office of Science Policy, National Institutes of Health, U.S. Department of Health and Human Services under Contract No. HHSN263201800029I. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13: 978-0-309-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/25917 Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2020 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2020. Framework for equitable allocation of COVID-19 vaccine. Washington, DC: The National Academies Press. https://doi.org/10.17226/25917. PREPUBLICATION COPY: UNCORRECTED PROOFS

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. PREPUBLICATION COPY: UNCORRECTED PROOFS

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. PREPUBLICATION COPY: UNCORRECTED PROOFS

COMMITTEE ON EQUITABLE ALLOCATION OF VACCINE FOR THE NOVEL CORONAVIRUS WILLIAM H. FOEGE (Co-Chair), Emeritus Distinguished Professor of International Health, Rollins School of Public Health, Emory University HELENE D. GAYLE (Co-Chair), President and Chief Executive Officer, The Chicago Community Trust MARGARET L. BRANDEAU, Coleman F. Fung Professor of Engineering, Professor of Medicine (by courtesy), Department of Management Science and Engineering, Stanford University ALISON M. BUTTENHEIM, Associate Professor of Nursing and Health Policy, University of Pennsylvania School of Nursing R. ALTA CHARO, Warren P. Knowles Professor of Law and Bioethics, University of Wisconsin Law School JAMES F. CHILDRESS, University Professor Emeritus, Institute for Practical Ethics and Public Life, University of Virginia ANA V. DIEZ ROUX, Dean and Distinguished University Professor of Epidemiology, Dornsife School of Public Health, Drexel University ABIGAIL ECHO-HAWK (Citizen of the Pawnee Nation), Director, Urban Indian Health Institute, Chief Research Officer, Seattle Indian Health Board CHRISTOPHER ELIAS, President, Global Development Division, Bill & Melinda Gates Foundation BARUCH FISCHHOFF, Howard Heinz University Professor, Department of Engineering and Public Policy, Institute for Politics and Strategy, Carnegie Mellon University DAVID MICHAELS, Professor, Environmental and Occupational Health, Milken Institute School of Public Health, The George Washington University JEWEL MULLEN, Associate Dean for Health Equity, Associate Professor of Population Health and Internal Medicine, The University of Texas at Austin Dell Medical School SAAD B. OMER, Director, Yale Institute for Global Health DANIEL POLSKY, Bloomberg Distinguished Professor of Health Policy and Economics, Carey Business School and Bloomberg School of Public Health, Johns Hopkins University SONJA RASMUSSEN, Professor of Pediatrics, Epidemiology, and Obstetrics and Gynecology, College of Medicine and College of Public Health and Health Professions, University of Florida ARTHUR L. REINGOLD, Division Head, Epidemiology and Biostatistics, Professor of Epidemiology, School of Public Health, University of California, Berkeley REED V. TUCKSON, Managing Director, Tuckson Health Connections, LLC MICHAEL R. WASSERMAN, President, California Association of Long Term Care Medicine Study Staff LISA BROWN, Study Director BENJAMIN KAHN, Associate Program Officer ELIZABETH FINKELMAN, Senior Program Officer AURELIA ATTAL-JUNCQUA, Associate Program Officer PREPUBLICATION COPY: UNCORRECTED PROOFS v

EMMA FINE, Associate Program Officer REBECCA CHEVAT, Senior Program Assistant ROSE MARIE MARTINEZ, Senior Director, Board on Population Health and Public Health Practice ANDREW M. POPE, Senior Director, Board on Health Sciences Policy Science Writer ANNA NICHOLSON PREPUBLICATION COPY: UNCORRECTED PROOFS vi

Reviewers This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We thank the following individuals for their review of this report: KIRSTEN BIBBINS-DOMINGO, University of California, San Francisco KATHRYN M. EDWARDS, Vanderbilt University EZEKIEL J. EMANUEL, University of Pennsylvania ALICIA FERNANDEZ, University of California, San Francisco TOM FRIEDEN, Resolve to Save Lives, an Initiative of Vital Strategies JAMES G. HODGE, Arizona State University NANCY E. KASS, Johns Hopkins University NICOLE LURIE, Coalition for Epidemic Preparedness Innovation and Harvard University KARA ODOM WALKER, Nemours Children's Health System JONATHAN M. SAMET, University of Colorado SUSAN L. SANTOS, VA NJ War Related Illness and Injury Study Center (WRIISC) JAIME SEPULVEDA, University of California, San Francisco KOSALI SIMON, Indiana University ANDY STERGACHIS, University of Washington STEN VERMUND, Yale University CONSUELO WILKINS, Meharry-Vanderbilt Alliance In addition, we again thank the reviewers that provided comments on the Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine, some of whom also served as reviewers for this report: G. CALEB ALEXANDER, Johns Hopkins University KATHRYN M. EDWARDS, Vanderbilt University EZEKIEL J. EMANUEL, University of Pennsylvania ALICIA FERNANDEZ, University of California, San Francisco TOM FRIEDEN, Resolve to Save Lives, an Initiative of Vital Strategies NANCY E. KASS, Johns Hopkins University SHIRIKI KUMANYIKA, Drexel University MARC LIPSITCH, Harvard University NICOLE LURIE, Coalition for Epidemic Preparedness Innovation and Harvard University M. GRANGER MORGAN, Carnegie Mellon University PREPUBLICATION COPY: UNCORRECTED PROOFS vii

WENDY E. PARMET, Northeastern University KOSALI SIMON, Indiana University STEN H. VERMUND, Yale University CONSUELO WILKINS, Meharry-Vanderbilt Alliance Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by BRUCE N. CALONGE, The Colorado Trust, ELLEN WRIGHT CLAYTON, Vanderbilt University Medical Center, and SUSAN J. CURRY, The University of Iowa. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies. PREPUBLICATION COPY: UNCORRECTED PROOFS viii

Contents ACRONYMS AND ABBREVIATIONS xv PREFACE xix SUMMARY S-1 1 INTRODUCTION 1-1 Study Charge, 1-1 About This Report, 1-3 Study Approach and Scope, 1-3 Report Audiences and Uses, 1-5 Organization of the Report, 1-5 COVID-19 and Health Equity Considerations, 1-6 Racial and Ethnic Equity, 1-6 Additional Health Equity Considerations, 1-9 COVID-19 Vaccine Landscape, 1-17 Vaccine Development, 1-17 Vaccine Manufacturing, 1-20 Financing and Purchasing, 1-21 Vaccine Distribution, 1-22 Contextualizing COVID-19 Vaccination Efforts in the Current System, 1-23 References, 1-25 2 LESSONS LEARNED FROM OTHER ALLOCATION EFFORTS 2-1 Lessons from Mass Vaccination Campaigns for Prior Infectious Disease Outbreaks, 2-1 H1N1 Influenza Vaccination Campaign (2009), 2-1 Vaccination Campaign During Ebola Epidemic in West Africa (2013–2016), 2-4 Frameworks for Allocating Pandemic Influenza Vaccines, 2-6 Lessons from Past Crisis Standard of Care Guidance, 2-7 Lessons from Guidance and Frameworks for Allocating Scarce Medical Resources During the COVID-19 Pandemic, 2-8 Ethnical Frameworks for Broadly Allocating Scarce Medical Resources, 2-8 Ethnical Frameworks for Specifically Allocating Scarce Inpatient Treatments for COVID-19, 2-11 Specific Frameworks for COVID-19 Vaccine Allocation Within and Among Countries, 2-16 Johns Hopkins Interim Framework for COVID-19 Vaccine Allocation and Distribution in the United States, 2-16 CDC’s Ongoing Vaccine Allocation Efforts, 2-17 PREPUBLICATION COPY: UNCORRECTED PROOFS ix

WHO SAGE Values Framework for the Allocation and Prioritization of COVID-19 Vaccination, 2-18 References, 2-22 3 A FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE 3-1 Foundational Principles of the Framework, 3-2 Foundational Principles, 3-3 COVID-19 Vaccine Allocation Framework, 3-10 Goal of the Framework, 3-10 Allocation Criteria, 3-11 Compatibility of Allocation Criteria with Foundational Principles, 3-12 Allocation Phases, 3-14 Phase 1, 3-21 Phase 1a, 3-21 Phase 1b, 3-24 Phase 2, 3-27 Phase 3, 3-33 Phase 4, 3-35 Ensuring Equity, 3-35 Vaccine Allocation for the Military, 3-38 Additional Considerations of the Framework, 3-38 Concluding Remarks, 3-39 Recommendation 1, 3-39 References, 3-40 4 APPLYING THE FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE IN VARIOUS SCENARIOS 4-1 An Adaptable and Dynamic Framework, 4-1 Number and Timing of Available Vaccine Doses, 4-2 Vaccine Efficacy, 4-3 Vaccine Safety, 4-3 Vaccine Uptake, 4-4 Number and Timing Available Vaccine Types, 4-4 Epidemic Conditions and Immune Status, 4-5 Vaccine Distribution and Administrations, 4-5 Social, Economic, and Legal Contexts, 4-6 References, 4-10 5 ADMINSTERING AND IMPLEMENTING AN EFFECTIVE AND EQUITABLE NATIONAL COVID-19 VACCINATION PROGRAM 5-1 Coordination of a National COVID-19 Vaccination Program, 5-1 CDC’s Coordinating Role, 5-2 COVID-19 Vaccine Distribution, 5-3 Leveraging Existing Systems to Support Coordination, 5-4 Monitoring and Evaluation, 5-5 Assessing COVID-19 Vaccine Coverage and Effectiveness, 5-6 PREPUBLICATION COPY: UNCORRECTED PROOFS x

Addressing Cost and Financing Barriers, 5-6 Cost Implications of the Coronavirus Aid, Relief, and Economic Security Act, 5-7 Medicare and Medicaid, 5-7 Additional Cost Barriers Related to Vaccination, 5-8 Additional Federal Funding Needed to Eliminate Financial Barriers, 5-8 Engaging Communities in Local COVID-19 Vaccination Plans, 5-9 STLT Implementation Requires Community Engagement, 5-9 Role of Community-Based Organizations in Vaccine Administration, 5-9 Role of Other Community Partners in Vaccine Administration, 5-10 Role of Workplaces, Employers, and Unions, 5-10 Importance of Communication, 5-10 Concluding Remarks, 5-11 Recommendation 2, 5-11 Recommendation 3, 5-12 References, 5-13 6 RISK COMMUNICATION AND COMMUNITY ENGAGEMENT 6-1 Scientific Foundations, 6-2 Risk Communication, 6-3 Risk Communication Content Goals, 6-3 Risk Communication Content, 6-4 Disease Processes That Can Be Misunderstood Unless Properly Explained, 6-4 Equity in Vaccination Program Procedures and Performance, 6-4 Empirical Testing, 6-4 Appropriate Tailoring, 6-5 Community Engagement, 6-5 Community Engagement Process, 6-7 Continuous Community Engagement, 6-7 Engagement Across Multiple Channels, 6-7 Timeliness, 6-7 Trustworthiness, 6-7 Risk Communication and Health Promotion, 6-8 Concluding Remarks, 6-8 Recommendation 4, 6-9 References, 6-9 7 ACHIEVING ACCEPTANCE OF COVID-19 VACCINE 7-1 The Landscape of Vaccine Hesitancy, 7-2 Vaccine Hesitancy Is Common and on the Rise, 7-2 Organized, Well-Funded, and Influential Anti-Vaccine Groups, 7-2 Medical Exploitation and Distrust, 7-3 Unique Challenges to COVID-19 Vaccine Acceptance, 7-4 WHO BeSD Increasing Vaccination Model, 7-4 Motivation, 7-5 Practical Issues, 7-5 Strategies for Vaccine Promotion and Addressing Vaccine Hesitancy, 7-6 PREPUBLICATION COPY: UNCORRECTED PROOFS xi

Concluding Remarks, 7-7 Recommendation 5, 7-8 Recommendation 6, 7-8 References, 7-9 8 ENSURING EQUITY IN COVID-19 VACCINE ALLOCATION GLOBALLY 8-1 Global Preparedness and Response to the COVID-19 Pandemic, 8-2 Global Preparedness Monitoring Board, 8-2 COVID-19 Vaccine Nationalism, 8-3 Access to COVID-19 Tools Accelerator and the COVAX Facility, 8-4 Access to COVID-19 Tools Accelerator, 8-4 GAVI’s Global Vaccine Procurement Strategy, 8-4 U.S. Participation in Global Vaccine Allocation, 8-5 The United States and the COVAX Facility, 8-5 Reasons to Support and Engage with Current Global Allocation Efforts, 8-6 Concluding Remarks, 8-8 Recommendation 7, 8-9 References, 8-9 APPENDIXES A STUDY METHODS A-1 B COMMITTEE AND STAFF BIOSKETCHES B-1 PREPUBLICATION COPY: UNCORRECTED PROOFS xii

Boxes, Figures, and Tables BOXES S-1 Key Lessons Learned from Prior Mass Vaccination Efforts, S-4 S-2 Summary of Recommendations, S-18 1-1 Statement of Task, 1-2 1-2 Key Terms Used Throughout the Report, 1-5 1-3 COVID-19 Risk Factors for Infection and for Severe Disease Associated with Social Determinants of Health, 1-8 1-4 CDC’s List of Medical Conditions That Increase the Risk of Severe COVID-19 Illness, 1-11 2-1 Key Lessons Learned from Prior Mass Vaccination Efforts, 2-5 2-2 Guiding Principles from Frameworks for Allocating Scarce Medical Resources During the COVID-19 Pandemic, 2-13 3-1 Foundational Principles for Equitable Allocation of COVID-19 Vaccine, 3-3 3-2 Health Inequities, 3-6 3-3 Risk-Based Criteria, 3-12 4-1 Unknowns Affecting Vaccine Allocation, 4-2 FIGURES S-1 Major elements of the framework for equitable allocation of COVID-19 vaccine, S-5 S-2 A phased approach to vaccine allocation for COVID-19, S-9 1-1 COVID-19 hospitalization per every 100,000 persons, stratified by age group, 1-10 1-2 Operation Warp Speed vaccine distribution process, 1-24 3-1 Major elements of the framework for equitable allocation of COVID-19 vaccine, 3-1 3-2 A phased approach to vaccine allocation for COVID-19, 3-20 6-1 An analytical deliberative process in which analysts and decision makers collaborate in managing risks, 6-6 PREPUBLICATION COPY: UNCORRECTED PROOFS xiii

7-1 WHO BeSD increasing vaccination model, 7-5 TABLES S-1 Key Data on the Impact of COVID-19 on Certain Populations, S-3 1-1 Key Data on the Impact of COVID-19 on Certain Populations, 1-16 1-2 Explanation of Phases of Vaccine Trials, 1-17 2-1 Overview of Principles and Prioritization Strategies Used in Frameworks for Allocating Scarce Medical Resources During the COVID-19 Pandemic, 2-14 2-2 Overview of Ongoing COVID-19 Vaccine Allocation Efforts, 2-20 3-1 Comparison of Principles Across Different Frameworks for COVID-19 Vaccine Allocation, 3-4 3-2 Applying the Allocation Criteria to Specific Population Groups, 3-16 4-1 Summary Table of the Application of the Committee’s Frameworks in Various Scenarios, 4-8 PREPUBLICATION COPY: UNCORRECTED PROOFS xiv

Acronyms and Abbreviations AAP American Academy of Pediatrics ACA Patient Protection and Affordable Care Act ACIP Advisory Committee on Immunization Practices ACT-A Access to COVID Tools (ACT) Accelerator ADI Area Deprivation Index AI American Indian AI/AN American Indian/Alaska Native AIDS acquired immunodeficiency syndrome AMC advanced market commitment AN Alaska Native ASPR assistant secretary for preparedness and response ATSDR Agency for Toxic Substances and Disease Registry BARDA Biomedical Advanced Research and Development Authority BeSD behavioral and social drivers of vaccination BJS Bureau of Justice Statistics BLA biologics license application BLS Bureau of Labor Statistics BMI body mass index CARES Coronavirus Aid, Relief, and Economic Security CCVI COVID-19 community vulnerability index CDC Centers for Disease Control and Prevention CEPI Coalition for Epidemic Preparedness Innovations CIDRAP Center for Infectious Disease Research and Policy CIHI Canadian Institute for Health CMS Centers for Medicare & Medicaid Services COPD chronic obstructive pulmonary disease COVID-19 coronavirus disease 2019 COVID-NET COVID-19 Associated Hospitalization Surveillance Network COVPN COVID-19 Prevention Trials Network CSC crisis standards of care CSO civil society and community organization DoD U.S. Department of Defense DHS U.S. Department of Homeland Security DSHS Texas Department of State Health Services PREPUBLICATION COPY: UNCORRECTED PROOFS xv

ED U.S. Department of Education EMS emergency medical services EPSDT early and periodic screening, diagnostics, and treatment EU European Union EUA emergency use authorization FDA U.S. Food and Drug Administration GAO U.S. Government Accountability Office GAVI Global Alliance for Vaccines and Immunization GPMB Global Preparedness Monitoring Board HHS U.S. Department of Health and Human Services HIV human immunodeficiency virus HMD Health and Medicine Division HPV human papillomavirus ICU intensive care unit IHR International Health Regulations IHS Indian Health Service IOM Institute of Medicine LGBTQ+ lesbian, gay, bisexual, transgender, queer, and others MCM medical countermeasure MMR measles, mumps, rubella mRNA messenger RNA NAM National Academy of Medicine n.d. no date NEJM New England Journal of Medicine NIAID National Institute of Allergy and Infectious Diseases NIH National Institutes of Health NPI nonpharmaceutical intervention NRC National Research Council NYPD New York Police Department NYT The New York Times OSHA Occupational Safety and Health Administration OWS Operation Warp Speed PHEP public health emergency preparedness PIDD primary immune deficiency disease PPE personal protective equipment PREP public readiness and emergency preparedness PREPUBLICATION COPY: UNCORRECTED PROOFS xvi

RAD-VAX rapid acceleration of delivery of vaccines RADx rapid acceleration of diagnostics RAPS Regulatory Affairs Professionals Society rVSV recombinant vesicular stomatitis virus–Zaire Ebola virus RZV recombinant zoster (shingles) vaccine SAGE Strategic Advisory Group of Experts SARS severe acute respiratory syndrome SARS-CoV-2 SARS coronavirus 2 STLT state, tribal, local, and territorial SVI Social Vulnerability Index TB tuberculosis TIP tailoring immunization programmes TTIQ testing linked to contract tracing, isolation, and quarantine UN United Nations USDA U.S. Department of Agriculture VAERS Vaccine Adverse Event Reporting System VSD Vaccine Safety Datalink VTrckS vaccine tracking system WHO World Health Organization PREPUBLICATION COPY: UNCORRECTED PROOFS xvii

Preface “Certainty,” Richard Feynman said, “is the Achilles heel of science.” We approach this task with humbleness and great uncertainty. At the time of writing, we do not know when a vaccine for coronavirus disease 2019 (COVID-19) will pass Phase 3 studies or will be licensed by the U.S. Food and Drug Administration. Even then, we will not know, the effectiveness of the vaccine in protecting the very old or the very young. If protective, we do not know the duration of protection. We do not know what will constitute primary immunization or the need for boosters, and we do not know if rare but potentially serious adverse events will occur, and, if so, in which groups. We do not understand the nuances of virus spread. What increases the risk of acquisition and transmission? How long does immunity last? How rare or frequent is reinfection? Are there preventive measures beyond masks, hand washing, social distancing, minimizing size of groups, and improving indoor air quality, not yet defined? How will a vaccine change the equation given the hesitancy expressed by many? How can risk categories be established that account for both personal and social vulnerabilities? What is the chance of a virus mutation that puts all of the investments in vaccine production at risk? In addition to these scientific uncertainties, we approached this task in the face of gaps and conflicts in legal authority and unprecedented economic and political uncertainty. The Centers for Disease Control and Prevention and National Institutes of Health and the understood such uncertainties but also understood the urgency of having guidance ready when a safe and effective vaccine becomes available. As such, these two agencies asked the National Academies of Sciences, Engineering, and Medicine to make recommendations on the equitable allocation of a COVID-19 vaccine by assembling the best recommendations from scientists, ethicists, psychologists, epidemiologists, and others using the latest information available. Despite an intense effort, this framework should still be regarded as an evolving document—meant to be adapted and refined by its implementers in the face of continuing improvement in our understanding of the dynamics of the pandemic. In embarking on our task, the committee started with equity. Inequity has been a hallmark of this pandemic, both locally and globally. Inequities in health have always existed, but at this moment there is an awakening to the power of racism, poverty, and bias in amplifying the health and economic pain and hardship imposed by this pandemic. Thus, we saw our work as one way to address these wrongs and do our part to work toward a new commitment to promoting health equity that is informed by but lives beyond this moment. The committee then approached what the science reveals about transmission, susceptibility, and risks of severe disease or death. The committee decided that a single objective, even one as important as mortality, obscures the impact of this virus on the triad of suffering, death and societal dysfunction. Therefore, a target of reducing all three seemed appropriate. PREPUBLICATION COPY: UNCORRECTED PROOFS xviii

Nobel Laureate Albert Schweitzer reminded us that suffering can often be a greater burden than death itself. The increase in poverty, the cost of isolation, and the inability to work or to be forced to work in unsafe environments, have led to mental as well as physical suffering of major proportions. The proposal of phases versus the usual nomenclature of tiers may appear to be insignificant or artificial. But, it seemed more dynamic, indicates movement, and eliminates the suggestion of any group having greater importance. It asserts that all life has equal value but also allows for the importance of making timing decisions about a potentially scarce resource. In the end, the real work will be done in states, localities, and tribal lands. It should use every lesson we have learned in getting vaccine to both children and adults. It should use the experience of a system that eliminated polio from this country and stopped measles transmission for long periods of time. It should use the commercial delivery systems that worked so well during the H1N1 outbreak. It should use every health worker and volunteer needed to make this a successful community and national effort. A report by a National Academies committee is not the same as effectively getting a message to the public.1 It does not vaccinate a single person. But, it can provide guidelines and be the impetus for one of the most consequential peacetime efforts this country has ever seen as well as a springboard to resuming our place as a leader in global health. “First, do no harm,” is repeated endlessly in medical education. We do far more harm, and kill far more people, by our errors of omission, rather than by our errors of commission. It is the science not shared, the vaccine not provided, the assistance not given, that results in suffering in other countries. We have a chance to protect ourselves and to be a leader in protecting the rest of the world. It is a challenge worthy of this country. Lastly, we want to say what a privilege, honor, and joy it has been to work with this committee and staff. The dedication to purpose and the esprit de corps that developed was impressive and heartening. It is exactly this kind of effort and selflessness that is needed to address a pandemic effectively, and this group definitely rose to the occasion. Thank you to Victor Dzau for his leadership and support throughout this activity. Thanks to Rose Martinez and Andy Pope for providing daily guidance in preparing a useful report. Special recognition goes to the staff; in particular, we note that Lisa Brown and Ben Kahn gave their all to support the committee process and writing of the report. They were tireless, thoughtful, and always pleasant despite the fact that “there are no weekends in a pandemic.” Liz Finkelman, Aurelia Attal- Juncqua, Emma Fine, and Rebecca Chevat rounded out the staff support and provided extensive assistance in the research and development of the report. What a joy it has been to work with such talented staff and committee members. Helene D. Gayle, Co-Chair William H. Foege, Co-Chair Committee on Equitable Allocation of Vaccine for the Novel Coronavirus 1 Bloom, B. R., G. J. Nowak, and W. Orenstein. 2020. “When will we have a vaccine?”—understanding questions and answers about COVID-19 vaccination. The New England Journal of Medicine. September 8, 2020. doi: 10.1056/NEJMp2025331. PREPUBLICATION COPY: UNCORRECTED PROOFS xix

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In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies.

Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors.

Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine.

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