The Smallpox Vaccination Program
Public Health in an Age of Terrorism
Alina Baciu, Andrea Pernack Anason, Kathleen Stratton, and Brian Strom, Editors
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
THE NATIONAL ACADEMIES PRESS
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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
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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
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
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
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
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
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
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
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
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
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.
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.
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
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The informed consent process for vaccine recipients
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Professional education and training materials
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Communication plans developed by CDC for public health and medical professionals and the public
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State smallpox vaccination implementation plans
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CDC guidelines and instruments to identify potential vaccine recipients at high risk of vaccine adverse events and complications
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CDC measures to ensure the early recognition, evaluation, and appropriate treatment of adverse events and complications of smallpox vaccination
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CDC plans for collecting and analyzing data on vaccine immunogenicity, adverse events, complications, and vaccine coverage
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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
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:
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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.
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To serve as a historical document that summarizes milestones in the smallpox vaccination program.
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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