Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation

Letter Report # 1

Committee on Smallpox Vaccination Program Implementation

Board on Health Promotion and Disease Prevention

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES



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Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation Letter Report # 1 Committee on Smallpox Vaccination Program Implementation Board on Health Promotion and Disease Prevention INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

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INSTITUTE OF MEDICINE 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. Support for this project was provided by Centers for Disease Control and Prevention. The views presented in this report are those of the Institute of Medicine Committee on Smallpox Vaccination Program Implementation and are not necessarily those of the funding agencies. Additional copies of this report are available in limited quantities from the Committee on Smallpox Vaccination Program Implementation; Board on Health Promotion and Disease Prevention; Institute of Medicine; 500 Fifth Street, NW; Washington, DC 20001. The full text of this report is available online at http://www.iom.edu/smallpox. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2003 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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“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Shaping the Future for Health

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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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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 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 ROBERT WALLACE, M.D., M.Sc., (Vice Chair), Professor of Epidemiology and Irene Ensminger Professorship in Cancer Research, 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 R. ALTA CHARO, J.D., Associate Dean for Research and Faculty Development, University of Wisconsin Law School and Professor of Law and Bioethics, University of Wisconsin Law School and Medical School THOMAS COATES, Ph.D., Professor of Medicine and Epidemiology, University of California, San Francisco PENELOPE DENNEHY, M.D., Associate Director of Pediatric Infectious Diseases, Hasbro Children’s Hospital and Professor of Pediatrics, Brown Medical School VINCENT FULGINITI, M.D., M.S., Professor Emeritus of Pediatrics, University of Arizona Health Sciences Center COLEEN KIVLAHAN, M.D., M.S.P.H., Vice President of Medical Affairs, University of Missouri Health Sciences Center KENNETH MCINTOSH, M.D., Professor of Pediatrics, Harvard Medical School and Professor of Immunology and Infectious Diseases, Harvard School of Public Health ELIZABETH MURANE, R.N., M.S., Public Health Nurse and Retired Director of Public Health Nursing for Shasta County, CA PETER ROSEN, M.D., Attending Emergency Medical Physician, Beth Israel Deaconess Hospital (Boston, MA) WILLIAM WESTON, M.D., Professor of Dermatology and Pediatrics, University of Colorado School of Medicine ROBERT WOOLSON, Ph.D., Professor of Biometry 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) Consultants WILLIAM H. FOEGE, M.D., M.P.H., Presidential Distinguished Professor, Department of International Health, Emory University and Health Advisor, Bill and Melinda Gates Foundation JEFFREY LEVINE, M.A., Vice President/Group Manager, Ketchum Washington, DC

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Study Staff KATHLEEN STRATTON, Ph.D., Study Director ALINA BACIU, M.P.H., Program Officer ANDREA PERNACK, M.P.H., Program Officer NICOLE AMADO, M.P.H., Research Associate AMBER CLOSE, Senior Project Assistant ROSE MARIE MARTINEZ, Sc.D., Director, Board on Health Promotion and Disease Prevention

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REVIEWERS This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's 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 individuals for their review of this report: 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., The 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, Harvard Center for Risk Analysis Thomas W. Valente, Ph.D., University of Southern California 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 Ronald Estabrook, Ph.D., University of Texas Southwestern. Appointed by the National Research Council and Institute of Medicine, 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 authoring committee and the institution.

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TABLE OF CONTENTS     BACKGROUND INFORMATION AND COMMITTEE PROCESS   2     SUMMARY OF KEY MESSAGES   4     GENERAL CONSIDERATIONS         National Security Concerns and the Unknown Balance of Risks and Benefits   4     Issue of Timing   6     Clarity   7     Compensation to Adverse Reactions to the Smallpox Vaccine   8     Workforce Issues Resulting from Vaccination   10     Opportunity Costs   11     SPECIFIC CONSIDERATIONS         Informed Consent Process   12     Screening Potential Vaccinees   14     Assessment of Safety Profile   17     Treatment of Vaccine Complications   22     CDC Safety System Guidance to States   23     Training and Education   23     Communication   27     Guidance to States   30     Overall Progress at Achieving the Goals of the Program   30     Areas of Potential Future Inquiry   31     CLOSING REMARKS   31     REFERENCE LIST   32     APPENDIX A   35     APPENDIX B   38