The Smallpox Vaccination Program

Public Health in an Age of Terrorism

Committee on Smallpox Vaccination Program Implementation

Board on Health Promotion and Disease Prevention

Alina Baciu, Andrea Pernack Anason, Kathleen Stratton, and Brian Strom, Editors

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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The Smallpox Vaccination Program: Public Health in an Age of Terrorism The Smallpox Vaccination Program Public Health in an Age of Terrorism Committee on Smallpox Vaccination Program Implementation Board on Health Promotion and Disease Prevention Alina Baciu, Andrea Pernack Anason, Kathleen Stratton, and Brian Strom, Editors INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract No. 200-2000-00629, Task Order No. 10 between the National Academy of Sciences and the Centers for Disease Control and Prevention. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. Library of Congress Cataloging-in-Publication Data The smallpox vaccination program : public health in an age of terrorism / Committee on Smallpox Vaccination Program Implementation, Board on Health Promotion and Disease Prevention ; Alina Baciu … [et al.], editors. p. ; cm. Supported by contract no. 200-2000-00629, task order no. 10 between the National Academy of Sciences and the Centers for Disease Control and Prevention. Includes bibliographical references and index. ISBN 0-309-09592-1 (pbk.)—ISBN 0-309-54877-2 (pdf) 1. Smallpox—Vaccination—Government policy—United States. I. Baciu, Alina. II. Institute of Medicine (U.S.). Committee on Smallpox Vaccination Program Implementation. [DNLM: 1. Immunization Programs—organization & administration—United States. 2. Smallpox—prevention & control—United States. 3. Bioterrorism—prevention & control—United States. 4. Government Programs—organization & administration—United States. 5. Health Policy—United States. 6. Smallpox Vaccine—United States. WC 588 S635 2005] RA644.S6S59 2005 614.5′21′0973—dc22 2005010062 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2005 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Adviser to the Nation to Improve Health

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism COMMITTEE ON SMALLPOX VACCINATION PROGRAM IMPLEMENTATION BRIAN STROM, M.D., M.P.H., (Chair), George S. Pepper Professor of Public Health and Preventive Medicine, Professor of Biostatistics and Epidemiology, Professor of Medicine and Professor of Pharmacology, University of Pennsylvania School of Medicine, Philadelphia KRISTINE GEBBIE, Dr.P.H., R.N., (Vice Chair), Elizabeth Standish Gill Associate Professor and Director of Center for Health Policy, Columbia University School of Nursing, New York, NY ROBERT WALLACE, M.D., M.Sc., (Vice Chair), Irene Esminger Stecher Professor of Epidemiology and Internal Medicine, University of Iowa E. RUSSELL ALEXANDER, M.D., Professor Emeritus of Epidemiology, School of Public Health and Community Medicine, University of Washington RONALD BAYER, Ph.D., Professor of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY R. ALTA CHARO, J.D., Associate Dean for Research and Faculty Development, University of Wisconsin Law School and Elizabeth S. Wilson Professor of Law and Bioethics, University of Wisconsin Law School and Medical School THOMAS COATES, Ph.D., Professor, Division of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles PENELOPE H. DENNEHY, M.D., Professor, Division of Pediatric Infectious Diseases, Brown Medical School, Providence, RI VINCENT FULGINITI, M.D., M.S., Professor Emeritus of Pediatrics, University of Arizona Health Sciences Center JAY HARPER, M.D., M.B.A., M.P.H., Medical Director of Employee Health Services, University of Pittsburgh Medical Center, Pittsburgh, PA COLEEN KIVLAHAN, M.D., M.S.P.H., Medical Director, Ambulatory Primary Care, Fantus Health Center, Bureau of Health Services, Cook County, IL JEFFREY LEVINE, M.A., Senior Vice President of Healthcare Media Relations, Hill & Knowlton, Washington, DC KENNETH MCINTOSH, M.D., Professor of Pediatrics, Harvard Medical School and Professor of Immunology and Infectious Diseases, Harvard School of Public Health, Boston, MA ELIZABETH MURANE, B.S.N., M.A., Public Health Nurse and Retired Director of Public Health Nursing, Shasta County, CA

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism PETER ROSEN, M.D., Attending Emergency Medical Physician, Beth Israel Deaconess Hospital, Boston, MA; Professor Emeritus of Clinical Medicine and Surgery, University of California, San Diego WILLIAM WESTON, M.D., Professor of Dermatology and Pediatrics, University of Colorado School of Medicine ROBERT WOOLSON, Ph.D., Professor of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina Health Promotion and Disease Prevention Board Liaison GEORGE ISHAM, M.D., Medical Director and Chief Health Officer, HealthPartners, Inc., Minneapolis, MN Consultant WILLIAM H. FOEGE, M.D., M.P.H., Presidential Distinguished Professor, Department of International Health, Emory University, Atlanta, GA, and Health Advisor, Bill and Melinda Gates Foundation Staff KATHLEEN STRATTON, Ph.D., Study Director ANDREA PERNACK ANASON, M.P.H., Program Officer ALINA BACIU, M.P.H., Program Officer NICOLE AMADO, M.P.H., Research Associate (until December 2003) AMBER CLOSE, M.F.S., Research Associate ROSE MARIE MARTINEZ, Sc.D., Director, Board on Health Promotion and Disease Prevention

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Reviewers This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for 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 wish to thank the following for their review of this report: John R. Ball, M.D., J.D., American Society for Clinical Pathology Kenneth I. Berns, M.D., Ph.D., University of Florida Edward N. Brandt, M.D., Ph.D., University of Oklahoma William K. Chiang, M.D., New York University Thomas N. Denny, M.Sc., New Jersey Medical School Lawrence O. Gostin, J.D., Johns Hopkins University and Georgetown University Law Center Peter Jensen, M.D., VA Medical Center, San Francisco Michael Katz, M.D., March of Dimes Stanley M. Lemon, M.D., University of Texas at Galveston Paul Light, Ph.D., Brookings Institution John Lumpkin, M.D., M.P.H., Robert Wood Johnson Foundation Nicole Lurie, M.D., M.S.P.H., RAND Corporation Tener Goodwin Veenema, R.N., Ph.D., M.P.H., M.S., CPNP, University of Rochester

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Bernard Lo, M.D., University of California, San Francisco, who was appointed by the Report Review Committee. He was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the author committee and the institution. The committee’s letter reports released between January 2003 and July 2004 (in Appendixes B-G) were also subject to independent review. Letter Report #1 Susan Allan, M.D., J.D., M.P.H., Arlington County Health Department, VA John G. Bartlett, M.D., Johns Hopkins University School of Medicine Doug Campos-Outcalt, M.D., M.P.A., Maricopa County Department of Public Health, AZ Richard T. Johnson, M.D., Johns Hopkins University School of Medicine J. Michael McGinnis, M.D., M.P.P., Robert Wood Johnson Foundation John M. Neff, M.D., Children’s Hospital and Regional Medical Center, Seattle, WA Tara O’Toole, M.D., M.P.H., Johns Hopkins University David Ropeik, M.S., Harvard Center for Risk Analysis Thomas W. Valente, Ph.D., University of Southern California Monitor appointed by NRC and IOM: Ronald Estabrook, Ph.D., University of Texas Southwestern Letter Report #2 Ruth Berkelman, M.D., Emory University Bobbie Berkowitz, Ph.D., R.N., University of Washington Mary Gilchrist, Ph.D., D(ABMM), University of Iowa Michael Katz, M.D., March of Dimes Birth Defects Foundation John Lumpkin, M.D., M.P.H., Illinois Department of Health Hugh H. Tilson, M.D., Dr.P.H., University of North Carolina Tener Goodwin Veenema R.N., Ph.D., M.P.H., M.S., CPNP, University of Rochester

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Monitor appointed by NRC and IOM: Elaine Larson, Ph.D., R.N.,., Columbia University Letter Report #3 John Ball, M.D., J.D., American Society for Clinical Pathology Ruth Berkelman, Emory University Bobbie Berkowitz, Ph.D., R.N., University of Washington R. Gordon Douglas, Jr., M.D., Cornell University Medical College Mary Gilchrist, Ph.D., D(ABMM), University of Iowa Peter Jensen, M.D., University of California, San Francisco Michael Katz, M.D., March of Dimes Birth Defects Foundation Fitzhugh Mullan, M.D., Health Affairs Tener Goodwin Veenema R.N., Ph.D., M.P.H., M.S., CPNP, University of Rochester Robert A. Weinstein, M.D., John Stroger Hospital of Cook County, IL Monitor appointed by NRC and IOM: Ronald Estabrook, Ph.D., University of Texas Southwestern Letter Report #4 Bobbie Berkowitz, Ph.D., R.N., University of Washington John Conte, M.D., University of California, San Francisco Michael Katz, M.D., March of Dimes Birth Defects Foundation John Lumpkin, M.D., M.P.H., Robert Wood Johnson Foundation Nicole Lurie, M.D., M.S.P.H., The RAND Corporation Hugh H. Tilson, M.D., Dr.P.H., University of North Carolina Monitor appointed by NRC and IOM: Ronald Estabrook, Ph.D., University of Texas Southwestern Letter Report #5 Mary Gilchrist, Ph.D., D(ABMM), University of Iowa Peter Jensen, M.D., VA Medical Center, San Francisco, CA John Lumpkin, M.D., M.P.H., Robert Wood Johnson Foundation Nicole Lurie, M.D., M.S.P.H., RAND Corporation Scott Ratzan, M.D., M.P.A., Johnson & Johnson Helen Smits, M.D., Eduardo Mondlane University Tener Goodwin Veenema R.N., Ph.D., M.P.H., M.S., CPNP, University of Rochester Robert Weinstein, M.D., John Stroger Hospital of Cook County, IL

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Monitor appointed by NRC and IOM: Ronald Estabrook, Ph.D., University of Texas Southwestern Letter Report #6 John R. Ball, M.D., J.D., American Society for Clinical Pathology Mary Gilchrist, Ph.D., D(ABMM), University of Iowa Peter Jensen, M.D., VA Medical Center, University of California, San Francisco John Lumpkin, M.D., M.P.H., Robert Wood Johnson Foundation Nicole Lurie, M.D., M.S.P.H., RAND Corporation Kimberley Shoaf, Dr.P.H., University of California, Los Angeles Hugh H. Tilson, M.D., Dr.P.H., University of North Carolina Monitor appointed by NRC and IOM: Ronald Estabrook, Ph.D., University of Texas Southwestern

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Acknowledgments This report and the series of brief, timely reports that preceded it represent the collaborative efforts of many organizations and individuals. The committee wishes to thank its liaison panel, drawn from the leadership of multiple public health, health care, and professional associations and organizations. Liaison panel members responded to committee queries and provided helpful information at the committee’s public meetings. Their diverse perspectives and expert input contributed in important ways to the committee’s work. The liaison panel included the following: American Academy of Dermatology, Connie J. Tegeler American Academy of Family Physicians, Herbert F. Young American Academy of Neurology, Richard T. Johnson American Academy of Ophthalmology, James Sprague American Academy of Pediatrics, Julia McMillan American Ambulance Association, Larry Wiersch America’s Health Insurance Plans,1 Carmella Bocchino American College of Occupational and Environmental Medicine, Rosemary Sokas American Federation of State, County and Municipal Employees, John A. Bonnage 1   Formerly American Association of Health Plans.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism American Hospital Association, Roslyne D.W. Schulman American Medical Association, James J. James American Nurses Association, Cheryl A. Peterson American Organization of Nurse Executives, Jo Ann Webb American Public Health Association, Georges C. Benjamin American Society for Clinical Pathology, Karen C. Carroll Association of State and Territorial Directors of Nursing, Prue Albright Association of State and Territorial Health Officials, George E. Hardy Council of State and Territorial Epidemiologists, Gianfranco Pezzino Emergency Nurses Association, Cheryl A. Smart Immune Deficiency Foundation, Jonathan C. Goldsmith International Association of Fire Chiefs, David Fischler National Association of County and City Health Officials, Patrick M. Libbey National Association of Emergency Medical Technicians, Paul M. Maniscalco National Association of Emergency Medical Technicians, John Roquemore National Association of EMS [Emergency Medical Services] Physicians, Robert O’Connor National Association of Public Hospitals and Health Systems, Edward L. Martinez National Association of State EMS [Emergency Medical Services] Directors, Margaret Trimble Service Employees International Union, William Borwegen The committee is grateful to the numerous individuals who generously shared their knowledge and expertise in their presentations to the committee at information-gathering meetings (agendas provided in Appendix H). Larry Anderson, Centers for Disease Control and Prevention Ron J. Anderson, Parkland Health & Hospital System, Texas Kris Arnold, International Association of Chiefs of Police Erik Auf der Heide, Agency for Toxic Substances and Disease Registry, Department of Health and Human Services Brad Austin, Health Resources and Services Administration Georges Benjamin, American Public Health Association Luciana Borio, Department of Health and Human Services Eddy Bresnitz, State of New Jersey Department of Health and Senior Services Shepard Cohen, National Association of Local Boards of Health Yehuda L. Danon, Professor of Pediatrics at Tel Aviv University, Israel Van Dunn, National Association of Public Hospitals and Health Systems

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Michael Edmond, Virginia Commonwealth University Health System Authority COL Renata Engler, Department of Defense Commissioner David Fischler, International Association of Fire Chiefs David Fleming, Centers for Disease Control and Prevention COL John Grabenstein, Department of Defense Franklyn Judson, Denver Health George Hardy, Association of State and Territorial Health Officials Joseph Henderson, Centers for Disease Control and Prevention Jon Mark Hirshon, American College of Emergency Physicians Katherine Kelley, Association of Public Health Laboratories Kelvin Kelkenberg, Department of Homeland Security Vicky Kipreos, Centers for Disease Control and Prevention Patrick Libbey, National Association of County and City Health Officials Yvonne Madlock, Memphis and Shelby County Health Department, Tennessee Gina Mootrey, Centers for Disease Control and Prevention John Neff, Vice-Chair of the Advisory Committee for Immunization Practices Working Group Karen Nikolai, Hennepin County Community Health Department, Minnesota Glenn Nowak, Centers for Disease Control and Prevention Robert O’Connor, National Association of EMS [Emergency Medical Services] Physicians Cheryl Peterson, National Nurses Association Gianfranco Pezzino, Kansas Department of Health and Environment and Council of State and Territorial Epidemiologists Alonzo Plough, National Association of County and City Health Officials Maggie Potter, University of Pittsburgh, Graduate School of Public Health Enrico (Henry) Quarantelli, Disaster Research Center, University of Delaware Linda Quick, Centers for Disease Control and Prevention William Raub, Department of Health and Human Services Bob Rehm, America’s Health Insurance Plans John Roquemore, National Association of Emergency Medical Technicians Lisa Rotz, Centers for Disease Control and Prevention Sandra Santa, Department of Homeland Security Roslyne D.W. Schulman, American Hospital Association Robert Schweitzer, Department of Homeland Security Mary Selecky, Washington State Department of Health

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Skip Skivington, Kaiser Permanente Dan Sosin, Department of Health and Human Services Lynn Steele, Centers for Disease Control and Prevention Ray Strikas, Centers for Disease Control and Prevention Jonathan Temte, American Academy of Family Physicians Kathleen Toomey, Division of Public Health, Georgia Department of Human Resources Margaret Trimble, National Association of State EMS [Emergency Medical Services] Directors Margaret VanAmringe, Joint Commission on Accreditation of Healthcare Organizations Donald Williamson, Association of State and Territorial Health Officials The Honorable William Winkenwerder, Assistant Secretary of Defense for Health Affairs, Department of Defense David J. Witt, Kaiser Permanente The committee would like to thank the numerous staff members of the Institute of Medicine, the National Research Council, and the National Academies Press who contributed to the development, production, and dissemination of this report, including study staff Kathleen Stratton, Andrea Pernack Anason, Alina Baciu, Nicole Amado, Amber Close, and Rose Marie Martinez, other staff in the Board on Health Promotion and Disease Prevention, Janice Mehler, Bronwyn Schrecker, Jennifer Bitticks, Christine Stencel and the Office of News and Public Information, and Norman Grossblatt.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Preface On December 13, 2002, the president of the United States announced that smallpox vaccination would be offered to some categories of civilians and administered to members of the military and government representatives in high-risk areas of the world. The events that precipitated that historic announcement included a series of terrorist attacks during the 1990s, which culminated in the catastrophic events of 2001. Deliberate releases of microbial and chemical agents had occurred in the past (for example, Salmonella in an Oregon salad bar, sarin gas in the Tokyo subway) but the juxtaposition of the September 2001 terrorist attacks in New York, Washington, and Pennsylvania and the October 2001 anthrax bioterrorism attacks represented a watershed; it provided a glimpse of the scale and devastation possible in an attack with biologic weapons. Speculation and concern among policy-makers and in the mass media about specific types of threats (such as the use of low-flying aircraft to spread biologic agents) compelled the general public to acknowledge the potential of bioterrorism on a large scale. Although preparedness for deliberate attacks with biologic weapons was already the subject of much public health planning, meetings, and publications as the twentieth century neared its end, the events of 2001 led to a steep rise in bioterrorism-related government policies and funding, and in state and local preparedness activities, for example, in public health, health care, and the emergency response and public safety communities. The national smallpox vaccination program is but one of many efforts to improve readiness to respond to deliberate releases of biologic agents.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism The Institute of Medicine (IOM) Committee on Smallpox Vaccination Program Implementation was convened in October 2002 at the request of the Centers for Disease Control and Prevention (CDC), the federal agency charged with implementing the government’s policy of providing smallpox vaccine first to public health and health care workers on response teams, then to all interested health care workers and other first responders, and finally to members of the general public who might insist on receiving the vaccine. The committee was charged with providing “advice to the CDC and the program investigators on selected aspects of the smallpox program implementation and evaluation.” The committee was asked to review and make recommendations to CDC to improve The informed consent process for vaccine recipients Professional education and training materials Communication plans developed by CDC for public health and medical professionals and the public State smallpox vaccination implementation plans CDC guidelines and instruments to identify potential vaccine recipients at high risk of vaccine adverse events and complications CDC measures to ensure the early recognition, evaluation, and appropriate treatment of adverse events and complications of smallpox vaccination CDC plans for collecting and analyzing data on vaccine immunogenicity, adverse events, complications, and vaccine coverage The achievement of overall goals of the smallpox vaccination program, such as vaccine coverage rate, equity of access, and adverse reaction rates The IOM committee faced some unusual challenges in its work, given the rapidly changing nature of the program and the need for multiple reports in a short period. The committee’s task was to review the implementation of the policy, not to comment on the policy itself. However, the committee has since recognized that the broader context in which the policy was developed and implemented may have created some unusual challenges within the program and may have affected its progress and outcomes. In public health practice, the success of implementation of any program depends in part on how convinced constituencies are of the correctness of a policy decision. In the case of pre-event vaccination, the committee has found evidence that many key actors had an unfavorable perception of the policy. They questioned the unknown rationale used in decision-making and requested information and clarification that were not made available, presumably because of national security concerns. The lack of clarity and the confusion and concern on the part of public health partners are further

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism reflected in the committee’s being asked for advice on the program by individuals involved in its implementation. In the end, those factors led to poor participation in the program. The committee met six times over 19 months and wrote a series of brief “letter” reports. This volume constitutes the committee’s seventh and final report, and the committee hopes that it will fulfill three purposes: To serve as an archival document that brings together the six reports addressed to Julie Gerberding, director of CDC, and previously released on line and as short, unbound papers. To serve as a historical document that summarizes milestones in the smallpox vaccination program. To comment on the achievement of overall goals of the smallpox vaccination program (in accordance with the last item in the charge), including lessons learned from the program. The committee is grateful for the opportunity to be of service to CDC as the agency and its state and local counterparts implemented a challenging program, and it hopes that this final report will support CDC and the public health community as they use the lessons learned from the program to strengthen the nation’s public health preparedness. Brian Strom, Committee Chair Kristine Gebbie, Committee Vice Chair Robert Wallace, Committee Vice Chair

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Contents     EXECUTIVE SUMMARY   1      References,   7 1   SMALLPOX AND SMALLPOX CONTROL IN THE HISTORICAL CONTEXT   9      A Brief History of Smallpox,   10      Understanding the Disease,   11      References,   19 2   POLICY CONTEXT OF SMALLPOX PREPAREDNESS   22      Steps Toward Readiness for a Smallpox Virus Release,   24      Concluding Observations,   34      References,   35 3   THE IMPLEMENTATION OF THE SMALLPOX VACCINATION PROGRAM   39      Major Milestones and Relevant Events,   41      Noteworthy Features of the Program,   58      Program Challenges,   60      Favorable Outcomes,   63      Concluding Observations,   65      References,   72

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism 4   LESSONS LEARNED FROM THE SMALLPOX VACCINATION PROGRAM   81      Absence of Explicit Scientific and Public Health Rationale for the Program,   81      Outcome Unknown: Has Smallpox Preparedness Been Enhanced?,   96      Concluding Observations,   100      References,   102     APPENDIXES         A  RECOMMENDATIONS FROM LETTER REPORTS 1–6   111      Recommendations from Letter Report #1,   111      Recommendations from Letter Report #2,   115      Recommendations from Letter Report #3,   117      Recommendations from Letter Report #4,   118      Recommendations from Letter Report #5,   120      Recommendations from Letter Report #6,   121     B  REVIEW OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION’S SMALLPOX VACCINATION PROGRAM IMPLEMENTATION, LETTER REPORT #1   123      Background Information and Committee Process,   124      Summary of Key Messages,   127      General Considerations,   127      Specific Considerations,   136      Closing Remarks,   159      References,   159     C  REVIEW OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION’S SMALLPOX VACCINATION PROGRAM IMPLEMENTATION, LETTER REPORT #2   162      Current Program Context,   163      Summary of Key Messages,   164      Overarching Issues: Preparedness and Evaluation,   164      Programmatic Issues,   170      Concluding Remarks,   192      References,   192     D  REVIEW OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION’S SMALLPOX VACCINATION PROGRAM IMPLEMENTATION, LETTER REPORT #3   195      General Comments,   196      Considerations for Next Steps in the Vaccination Program,   197

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism      Comments About the Guidance,   200      References,   201     E  REVIEW OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION’S SMALLPOX VACCINATION PROGRAM IMPLEMENTATION, LETTER REPORT #4   203      Integrating Smallpox Preparedness into Overall Public Health Preparedness,   204      Vaccination of Members of the General Public Who Insist on Receiving Smallpox Vaccine,   222      Selected Aspects of Smallpox Vaccination Program Implementation,   226      Concluding Remarks,   242      References,   243      Letter Report #4, Appendix Summary of Recommendations: Integrating Smallpox Preparedness into Overall Public Health Preparedness,   248      Vaccination of Members of the General Public Who Insist on Receiving Smallpox Vaccine,   249      Selected Aspects of Smallpox Vaccination Program Implementation,   250     F  REVIEW OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION’S SMALLPOX VACCINATION PROGRAM IMPLEMENTATION, LETTER REPORT #5   252      Introduction,   253      General Parameters of Four Scenarios to Assess Smallpox Readiness Indicators,   255      Comments About the Draft Readiness Indicators,   262      Concluding Remarks,   274      References,   275     G  REVIEW OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION’S SMALLPOX VACCINATION PROGRAM IMPLEMENTATION, LETTER REPORT #6   285      Introduction,   286      Integrating Public Health into Disaster Preparedness and Response: Conceptual Issues,   288      Challenges and Opportunities Inherent in Integrating Public Health into a Broader Field,   292      The Evidence Base from Disaster Research and Practice,   299      Learning from the Public Health Response to Proxy Events,   304

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism      Usefulness of Modeling,   308      Usefulness of Exercises,   312      Concluding Remarks,   320      References,   321     H  AGENDAS FOR COMMITTEE INFORMATION-GATHERING MEETINGS   329     I  COMMITTEE BIOSKETCHES   342      INDEX   349