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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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Future State of
Smallpox Medical
Countermeasures

_____

Lawrence O. Gostin, Lisa Brown, Shalini Singaravelu,
and Matthew Masiello, Editors

Committee on the Current State of Research,
Development, and Stockpiling of Smallpox Medical
Countermeasures

Board on Health Sciences Policy

Board on Global Health

Health and Medicine Division

Board on Life Sciences

Division on Earth and Life Studies


Consensus Study Report

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by contracts between the National Academy of Sciences and the Administration for Strategic Preparedness and Response (75A50121C00061). 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: 978-0-309-71737-3
International Standard Book Number-10: 0-309-71737-x
Digital Object Identifier: https://doi.org/10.17226/27652
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2024. Future state of smallpox medical countermeasures. Washington, DC: The National Academies Press. https://doi.org/10.17226/27652.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
×

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.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
×

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 on 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.

Rapid Expert Consultations published by the National Academies of Sciences, Engineering, and Medicine are authored by subject-matter experts on narrowly focused topics that can be supported by a body of evidence. The discussions contained in rapid expert consultations are considered those of the authors and do not contain policy recommendations. Rapid expert consultations are reviewed by the institution before release.

For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
×

COMMITTEE ON THE CURRENT STATE OF RESEARCH, DEVELOPMENT, AND STOCKPILING OF SMALLPOX MEDICAL COUNTERMEASURES

LAWRENCE GOSTIN (Chair), Distinguished University Professor, O’Neil Chair in Global Health Law, O’Neill Institute for National and Global Health Law, Georgetown University

GEORGES BENJAMIN, Executive Director, American Public Health Association

NAHID BHADELIA, Director, Boston University Center on Emerging Infectious Diseases, Associate Professor, Boston University School of Medicine

INGER DAMON, Adjunct Clinical Faculty, Emory University Department of Medicine

ANDREW ENDY, Martin Family University Fellow in Undergraduate Education, Faculty Co-Director of Degree Programs, Hasso Plattner Institute of Design, Core Faculty, Stanford University Center for International, Security and Cooperation, Senior Fellow (courtesy), Hoover Institution

DIANE E. GRIFFIN, University Distinguished Service Professor, W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health

NOREEN HYNES, Associate Professor of Medicine (Infectious Diseases) and Public Health (International Health), Director of Research and Associate Medical Director (Infectious Diseases), Johns Hopkins Hospital Biocontainment Unit, Director, Geographic Medicine Center for the Division of Infectious Diseases, Johns Hopkins University School of Medicine, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Hospital

RICHARD KENNEDY, Professor of Medicine, Mayo Clinic and Foundation, Co-Director, Mayo Clinic Vaccine Research Group

KENT KESTER, Vice President, Translational Medicine, International AIDS Vaccine Initiative

ANNE RIMOIN, Professor, Department of Epidemiology, Gordon Levin Endowed Chair in Infectious Diseases and Public Health, Director, Center for Global and Immigrant Health, Jonathan and Karin Fielding School of Public Health, University of California, Los Angeles

OYEWALE TOMORI, Professor of Virology, African Center of Excellence for Genomics of Infectious Diseases

HENRY WILLIS, Senior Policy Researcher, Professor, RAND Corporation, Pardee RAND Graduate School

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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MATTHEW WYNIA, Director, Center for Bioethics and Humanities, University of Colorado

ZHILONG YANG, Associate Professor, Department of Veterinary Pathobiology, School of Veterinary Medicine & Biomedical Sciences, Texas A&M University

Study Staff

LISA BROWN, Study Director

SHALINI SINGARAVELU, Program Officer

MATTHEW MASIELLO, Associate Program Officer

MARGARET MCCARTHY, Research Associate (until December 31, 2023)

CLAIRE BIFFL, Research Associate (from January 1, 2024)

RAYANE SILVA-CURRAN, Senior Program Assistant

KAVITA BERGER, Board Director, Board on Life Sciences

JULIE PAVLIN, Senior Board Director, Board on Global Health

CLARE STROUD, Senior Board Director, Board on Health Sciences Policy

Consultant

ELLEN CARLIN, Parapet Science & Policy Consulting

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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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:

DAVID BLAZES, Bill & Melinda Gates Foundation

MIKE BRAY, Georgetown Medical School

WILLIAM GREG BUREL, Hamilton Grace, LLC

JOHN H. CONNOR, National Emerging Infectious Diseases Laboratories, Boston University Chobanian and Avedisian School of Medicine

R. ALTA CHARO, University of Wisconsin–Madison

RICHARD HATCHETT, Coalition for Epidemic Preparedness Innovations

BERNARD MOSS, National Institutes of Health

UMAIR A. SHAH, Washington State Department of Health

ERICA SHENOY, Massachusetts General Hospital

JILL TAYLOR, Association of Public Health Laboratories

CRYSTAL WATSON, Johns Hopkins Bloomberg School of Public Health

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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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 ANN M. ARVIN, Stanford University, and LAWRENCE COREY, Fred Hutchinson Cancer Center. 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.

Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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Preface

Immediately after the eradication of smallpox, nations around the world mobilized to ensure that future generations would not continue to suffer from this ancient and devastating disease. World Health Assembly resolution 33.4 declared that smallpox had been eradicated and recommended policies on vaccination, case investigation, and the limited retention of variola collections in the event of a future re-emergence. However, rapid societal, political, ecological, and technological changes of the 21st century have shed new light on these historical resolutions and the need to reevaluate public health and health systems capacities against natural and intentional threats. As evidenced by recent public health emergencies of international concern, the U.S. public—and the global community at large—expects the United States and its international partners, including the World Health Organization, to rapidly identify an outbreak and equitably make available safe and effective medical countermeasures (MCMs), such as effective diagnostics, therapeutics, biologics, and vaccines. These expectations hold true regardless of the pathogen causing the disease.

The National Academies of Sciences, Engineering, and Medicine’s Committee on the Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures was tasked with providing strategic counsel to the federal government and international partners regarding the future of the smallpox MCMs portfolio (including research, development, and stockpiling) to ensure readiness and effective response in the event of a smallpox event.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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As articulated in this report, the committee envisions a responsive and flexible system to establish research priorities for smallpox MCMs, together with judicious stockpiling and strategic plans for the rapid and equitable distribution of MCMs in the event of a smallpox or other orthopoxvirus outbreak, in the United States or globally. Concurrently, the committee emphasizes the optimal use of governmental resources to achieve effective smallpox preparedness, while recognizing the competing demands placed on the government to also be prepared for other significant threats.

This type of system will require U.S. and international partners to plan and respond in the face of multiple scientific, societal, political, and ecological uncertainties. These uncertainties—and lessons learned from COVID and mpox—argue for research and stockpiling decisions to be made in anticipation of the next potential threat, with a readiness to shift priorities rapidly in the face of emerging information.

It is vital to prioritize research into and the development of safer and more effective MCMs, to make judicious choices about stockpiling, and to have modern, well rehearsed, and adaptable strategic plans in place to respond nationally and globally in the event of a variola or other orthopoxvirus outbreak. These efforts will depend on rapid identification (diagnostics and surveillance), effective containment and response, equitable allocation, and global solidarity.

On behalf of the committee and the project staff, I extend my sincere thanks to the many individuals who shared their time and expertise to support the committee’s work and inform its deliberations. The study was sponsored by the Administration for Strategic Preparedness and Response on behalf of the U.S. government, and we thank Margaret Sloane and Julia Limage for their guidance and support. The committee extends great thanks and appreciation to Christy Huston of the U.S. Centers for Disease Control and Prevention and Rosamund Lewis of the World Health Organization Smallpox Secretariat for their technical advice. Our appreciation goes to the reviewers for their invaluable feedback and to the monitor and coordinator who oversaw the report review.

The committee acknowledges the many staff within the National Academies who provided support in various ways to this project, including Lisa Brown, Shalini Singaravelu, Matthew Masiello, Margaret McCarthy, Claire Biffl, and Rayane Silva-Curran. The committee also extends their gratitude to Clare Stroud, senior board director of the Board on Health Sciences Policy. Ellen Carlin provided research and writing assistance, Anne Marie Houppert assisted in compiling literature, and the report review, production, and communications staff all provided valuable guidance to ensure the success of the final product.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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Finally, I would like to deeply thank the committee of experts who volunteered their invaluable time to this task. The committee’s contributions to this report are reflective of their career-long dedication and service to epidemic and pandemic preparedness and response.

Lawrence O. Gostin, Chair
Committee on the Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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Acronyms and Abbreviations

ACIP Advisory Committee on Immunization Practices
ACVVR Advisory Committee on Variola Virus Research
AI artificial intelligence
AIDS acquired immunodeficiency syndrome
APSV Aventis Pasteur smallpox vaccine
ARPA-H Advanced Research Projects Agency for Health
ASPR Administration for Strategic Preparedness and Response
BARDA Biomedical Advanced Research and Development Authority
BioMADE BioIndustrial Manufacturing and Design Ecosystem
BioMaP National Biopharmaceutical Manufacturing Partnership
CBRN chemical, biological, radiological, and nuclear
CDC U.S. Centers for Disease Control and Prevention
CDV cidofovir
CEPI Coalition for Epidemic Preparedness
CIADM Centers for Innovation in Advanced Development and Manufacturing
CLIA Clinical Laboratory Improvement Amendments
CMS Centers for Medicare & Medicaid Services
CMV cytomegalovirus
COVID-19 coronavirus disease 2019; the disease caused by the virus SARS-CoV-2
CRISPR clustered regularly interspaced short palindromic repeats
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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DNA deoxyribonucleic acid
DoD Department of Defense
EA IND expanded access for an investigational new drug
EIND emergency investigational new drug
ELISA enzyme-linked immunosorbent assay
EM electron microscopy
EU European Union
EUA Emergency Use Authorization
EV enveloped virion
FDA U.S. Food and Drug Administration
FD&C Food, Drug, and Cosmetic Act
FY fiscal year
GAO Government Accountability Office
GMP good manufacturing practice
HERA Health Emergency Preparedness and Response Authority
HHS Department of Health and Human Services
HIV human immunodeficiency virus
IgG immunoglobulin G
IgM immunoglobulin M
IND investigational new drug
IOM Institute of Medicine
IR inverted repeat
ITAP Independent Test Assessment Program
IV intravenous
KFF Kaiser Family Foundation
LAMP loop mediated isothermal amplification
LDT laboratory developed tests
LLM large language model
LRN Laboratory Response Network
mAbs monoclonal antibodies
MCM medical countermeasure
MERS-CoV Middle East respiratory syndrome coronavirus
MPXV monkeypox
mRNA messenger ribonucleic acid
MV mature virion
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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MVA modified vaccinia Ankara
MVA-BN modified vaccinia Ankara-Bavarian Nordic
NIAID National Institute of Allergy and Infectious Diseases
NIH National Institutes of Health
NYCBOH New York City Board of Health
OPXV orthopoxvirus
OWS Operation Warp Speed
PCR polymerase chain reaction
PHEMCE Public Health Emergency Medical Countermeasures Enterprise
POC point-of-care
PON point-of-need
PPE personal protective equipment
qPCR quantitative polymerase chain reaction
SAGE Strategic Advisory Group of Experts on Immunization
SARS severe acute respiratory syndrome
SARS-CoV-2 severe acute respiratory syndrome-related coronavirus
SCARDA Strategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness and Response
SNS U.S. Strategic National Stockpile
STOMP Study of Tecovirimat for Human Monkeypox Virus
SVES Smallpox Vaccine Emergency Stockpile
TPP target product profile
VARV variola virus
VECTOR State Research Center of Virology and Biotechnology
VIG vaccinia immunoglobulin
VIGIV vaccinia immune globulin intravenous
WHA World Health Assembly
WHO World Health Organization
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2024. Future State of Smallpox Medical Countermeasures. Washington, DC: The National Academies Press. doi: 10.17226/27652.
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Acknowledgments

This Consensus Study Report would not have been possible without the many experts who generously contributed their time and expertise to inform the development of this report. The committee thanks all the speakers (Appendix A) for their timely participation and expert contributions to the public workshops: Steve Adams, Paul Chaplin, Matthew Clark, Gavin Cloherty, John Connor, Nicole Dorsey, Manoj Gandhi, Noel Gerald, Matthew Hepburn, Dennis Hruby, Nathaniel Hupert, Christy Hutson, Stuart Isaacs, Cyrus Javan, Ewa King, Brett Leav, Seth Lederman, Rosamund Lewis, Julia Limage, Karen Martins, Cathryn Mayes, Bernard Moss, Marcus Plescia, Chris Sinclair, Margaret Sloane, Crystal Watson, Daniel Wolfe, and Kevin Yeskey. The committee is deeply appreciative of the following individuals who contributed their expertise on poxvirus research: Jia Liu, Grant McFadden, Stefan Rothenburg, and Yan Xiang.

The committee would also like to thank the sponsor of this study. Funds for the committee’s work was provided by the Administration for Strategic Preparedness and Response (ASPR). The committee also extends their gratitude to the group of interagency federal experts for informing the committee’s charge.

Many others within the National Academies supported this project. The committee thanks the staff of the Health and Medicine Division (HMD) Executive Office, Office of Communications, Office of Governmental Affairs, and Research Center. The committee is grateful to Ellen Carlin for her invaluable contributions to conducting research, report writing, and editing. Finally, Robert Pool is to be credited for his editorial assistance in preparing this report.

We are deeply grateful to all those who collaborated on this project for working so diligently under a very short timeline.

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At the request of the Administration for Strategic Preparedness and Response, the National Academies convened a committee to examine lessons learned from the COVID-19 pandemic and mpox multi-country outbreak to inform an evaluation of the state of smallpox research, development, and stockpiling of medical countermeasures (MCM). In the resulting report, the committee presents findings and conclusions that may inform U.S. Government investment decisions in smallpox MCM readiness, as well as the official U.S. position on the disposition of live viral collections at future World Health Assembly meetings.

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