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
A Consensus Study Report of
and
NATIONAL ACADEMY OF MEDICINE
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
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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 (HHSN263201800029I). 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: 978-0-309-68224-4
International Standard Book Number-10: 0-309-68224-X
Digital Object Identifier: https://doi.org/10.17226/25917
Library of Congress Control Number: 2020947136
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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.
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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 A. 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
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
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:
In addition, we again thank the reviewers who 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:
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.
Contents
COVID-19 and Health Equity Considerations
Contextualizing COVID-19 Vaccination Efforts in the Current System
2 LESSONS LEARNED FROM OTHER ALLOCATION EFFORTS
Lessons from Mass Vaccination Campaigns for Prior Infectious Disease Outbreaks
Lessons from Past Crisis Standards of Care Guidance
Specific Frameworks for COVID-19 Vaccine Allocation Within and Among Countries
3 A FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE
Foundational Principles of the Framework
COVID-19 Vaccine Allocation Framework
4 APPLYING THE FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE IN VARIOUS SCENARIOS
An Adaptable and Dynamic Framework
5 ADMINISTERING AND IMPLEMENTING AN EFFECTIVE AND EQUITABLE NATIONAL COVID-19 VACCINATION PROGRAM
Coordination of a National COVID-19 Vaccination Program
Addressing Cost and Financing Barriers
Engaging Communities in Local COVID-19 Vaccination Plans
6 RISK COMMUNICATION AND COMMUNITY ENGAGEMENT
Risk Communication Content Goals
Risk Communication and Health Promotion
7 ACHIEVING ACCEPTANCE OF COVID-19 VACCINE
The Landscape of Vaccine Hesitancy
WHO BeSD Increasing Vaccination Model
Strategies for Vaccine Promotion and Addressing Vaccine Hesitancy
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FIGURES
S-1 Major elements of the framework for equitable allocation of COVID-19 vaccine
S-2 A phased approach to vaccine allocation for COVID-19
1-1 COVID-19 hospitalizations per every 100,000 persons, stratified by age group
1-2 Operation Warp Speed vaccine distribution process
3-1 Major elements of the framework for equitable allocation of COVID-19 vaccine
3-2 A phased approach to vaccine allocation for COVID-19
7-1 WHO BeSD Increasing Vaccination Model
TABLES
S-1 Key Data on the Impact of COVID-19 on Certain Populations
1-1 Key Data on the Impact of COVID-19 on Certain Populations
1-2 Explanation of Phases of Vaccine Trials
2-2 Overview of Ongoing COVID-19 Vaccine Allocation Efforts
3-1 Comparison of Principles Across Different Frameworks for COVID-19 Vaccine Allocation
3-2 Applying the Allocation Criteria to Specific Population Groups
4-1 Summary Table of the Application of the Committee’s Framework in Various Scenarios
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/AN | American Indian/Alaska Native |
| AMC | advanced market commitment |
| BeSD | behavioral and social drivers of vaccination |
| 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 |
| CMS | Centers for Medicare & Medicaid Services |
| COVID-19 | coronavirus disease 2019 |
| COVID-NET | COVID-19 Associated Hospitalization Surveillance Network |
| CSC | crisis standards of care |
| DHS | U.S. Department of Homeland Security |
| DoD | U.S. Department of Defense |
| EMS | emergency medical services |
| EU | European Union |
| EUA | Emergency Use Authorization |
| FDA | U.S. Food and Drug Administration |
| GPMB | Global Preparedness Monitoring Board |
| HHS | U.S. Department of Health and Human Services |
| HMD | Health and Medicine Division |
| 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 |
| mRNA | messenger RNA |
| NAM | National Academy of Medicine |
| n.d. | no date |
| NIAID | National Institute of Allergy and Infectious Diseases |
| NIH | National Institutes of Health |
| OSHA | Occupational Safety and Health Administration |
| OWS | Operation Warp Speed |
| PHEP | public health emergency preparedness |
| PPE | personal protective equipment |
| PREP | Public Readiness and Emergency Preparedness |
| 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 |
| VTrckS | Vaccine Tracking System |
| WHO | World Health Organization |
Preface
“Certainty,” Richard Feynman said, “is the Achilles heel of science.” We approach this task with humbleness and great uncertainty. At the time of this writing, we do not know when a vaccine for coronavirus disease 2019 (COVID-19) will pass Phase III 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 the National Institutes of Health 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.
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
___________________
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.
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 Marie Martinez and Andrew Pope for providing daily guidance in preparing a useful report. Special recognition goes to the staff; in particular, we note that Lisa Brown and Benjamin 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.” Elizabeth 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
