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CONSIDERATIONS FOR VIRAL DISEASE ERADICATION Lessons Learned and Future Strategies Workshop Summary Stacey Knobler, Joshua Lederberg, and Leslie A. Pray, Ea/itors Forum on Emerging Infections Board on Global Health INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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NATIONAL ACADEMY PRESS 2101 Consutut~on Avenue, N.W. Washington, DC 20418 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. Support for this project was provided by the U.S. Department of Health and Human Services' National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration; U.S. Department of Defense; U.S. Department of State; U.S. Department of Veterans Affairs; U.S. Agency for International Development; Abbott Laboratories; American Society for Microbiology; Bristol-Myers Squibb Company; Burroughs Wellcome Fund, Eli Lilly & Company; The Ellison Medical Foundation; Glaxo Wellcome; F. Hoffmann-La Roche AG; Pfizer, Inc.; SmithKline Beecham Corporation; and Wyeth-Ayerst Laboratories. The views presented in this report are those of the Institute of Medicine Forum on Emerging Infections and are not necessarily those of the funding agencies. This report is based on the proceedings of a workshop that was sponsored by the Forum on Emerging Infections. It is prepared in the form of a workshop summary by and in the name of the editors, with the assistance of staff and consultants, as an individually authored document. Sections of the workshop summary not specifically attributed to an individual reflect the views of the editors and not those of the Forum on Emerging Infections. The content of those sections is based on the presentations and the discussions that took place during the workshop. Library of Congress Cataloging-in-Publication Data Considerations for viral disease eradication: lessons learned and future strategies: workshop summary / Stacey Knobler, Joshua Lederberg, and Leslie A. Pray, editors; Forum on Emerging Infections, Board on Global Health, Institute of Medicine. p. ; cm. Includes bibliographical references. ISBN 0-309-08414-8 (pbk.) 1. Virus diseases—Vaccination Congresses. 2. Virus diseases—Prevention—Congresses. 3 . Medical policy—Congresses. [DNLM: 1. Communicable Disease Control—trends~ongresses. 2. Immunization—trends~ongresses. 3. Virus Diseases—prevention & control~ongresses. 4. Health Policy Congresses. 5. World Health—Congresses. WA 110 C755 2002] I. Knobler, Stacey. II. Lederberg, Joshua. m. Pray, Leslie A. IV. Institute of Medicine (U.S.). Forum on Emerging Infections. RA644.V55 C66 2002 614.5'75—dc21 2002005549 Additional copies of this report are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055. Call (800) 624-6242 or (202) 334- 3313 (in the Washington metropolitan area), or visit the NAP's home page at www.nap.edu. The full text of this report is available at www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2002 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. COVER: The background for the cover of this workshop summary is a photograph of a batik designed and printed specifically for the Malaysian Society of Parasitology and Tropical Medicine. The print contains drawings of various parasites and insects; it is used with the kind permission of the Society.

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"I(nowin,g is not enough; we mast apply. Willin,g is not enough; we must do. " - Goethe ,~ Ad/ INSTITUTE OF MEDICINE Shaping the Future for Health

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National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council ~ jv>~.~A~ ,,. (it\ a) .. .~.~.0 ... 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 Acad- emy 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 engi- neers. 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is presi- dent 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 Coun- cil is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chairman and vice chairman, respec- tively, of the National Research Council.

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FORUM ON EMERGING INFECTIONS JOSHUA LEDERBERG (Chair), Raymond and Beverly Sackler Foundation Scholar, The Rockefeller University, New York, New York STEVEN BRICKNER, Research Advisor, Pfizer Global Research and Development, Pfizer Inc., Groton, Connecticut GAIL CASSELL, Vice President, Infectious Diseases, Eli Lilly & Company, Indianapolis, Indiana GARY CHRISTOPHERSON, Senior Advisor for Force Health Protection, Office of the Assistant Secretary of Defense, Department of Defense, Washington, D.C. GORDON DEFRIESE, Professor of Social Medicine, University of North Carolina, Chapel Hill, North Carolina CEDRIC DUMONT, Medical Director, U.S. Department of State and Foreign Service, Washington, D.C. JESSE GOODMAN, Deputy Director, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland RENU GUPTA, Vice President and Head, U.S. Clinical Research and Development, and Head, Global Cardiovascular, Metabolic, Endocrine, and G.I. Disorders, Novartis Corporation, East Hanover. New Jersey MARGARET HAMBURG, Vice President for Biological Programs, Nuclear Threat Initiative, Washington, D.C. CAROLE HEILMAN, Director, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland JAMES HURRIES, Assistant Surgeon General and Director, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia SAMUEL KATZ, Wilburt C. Davison Professor and Chairman Emeritus, Duke University Medical Center, Durham, North Carolina PATRICK KELLEY, Colonel, Director, Department of Defense Global Emerging Infections System, Walter Reed Army Institute of Research, Silver Spring, Maryland MARCELLE LAYTON, Assistant Commissioner, Bureau of Communicable Diseases, New York City Department of Health, New York, New York CARLOS LOPEZ, Research Fellow, Research Acquisitions, Eli Lilly Research Laboratories, Indianapolis, Indiana v

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LYNN MARKS, Global Head of Infectious Diseases, GlaxoSmithKline, Collegeville, Pennsylvania STEPHEN MORSE, Director, Center for Public Health Preparedness, Columbia University, New York, New York MICHAEL OSTERHOLM, Director, Center for Infectious Disease Research and Policy and Professor, School of Public Health, University of Minnesota, Minneapolis, Minnesota GARY ROSELLE, Program Director for Infectious Diseases, VA Central Office, Veterans Health Administration, Department of Veterans Affairs, Washington, D.C. DAVID SHLAES, Vice President, Infectious Disease Research, Wyeth, Pear! River, New York JANET SHOEMAKER, Director, Office of Public Affairs, American Society for Microbiology, Washington, D.C. P. PREDRICK SPARLING, I. Herbert Bate Professor Emeritus of Medicine, Microbiology, and Immunology, University of North Carolina, Chapel Hill, North Carolina KAYE WACHSMUTH, Deputy Administrator, Office of Public Health and Science, United States Department of Agriculture, Washington, D.C. C. DOUGLAS WEBB, Senior Medical Director, Bristol-Myers Squibb Company, Princeton, New Jersey Liaisons to the Forum ENRIQIJETA BOND, President, Burroughs Welicome Fund, Research Triangle Park, North Carolina NANCY CARTER-FOSTER, Director, Program for Emerging Infections and HIV/AIDS, U.S. Department of State, Washington, D.C. MICHAEL MORAN, Associate Vice President of Clinical Affairs, Pharmaceutical Research and Manufacturers Association, Washington, D.C. EDWARD) McSWEEGAN, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland STEPHEN OSTROFF, Associate Director for Epidemiologic Science, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia FRED TENOVER, Chief, Nosocomial Pathogens Laboratory Branch, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia At

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Staff JONATHAN DAVIS, Senior Program Officer (until May 2001) STACEY KNOBLER, Director, Forum on Emerging Infections MAR]AN NAJAFI, Research Associate LAURIE SPINELLI, Project Assistant VII

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BOARD ON GLOBAL HEALTH DEAN JAMISON (Chair), Director, Program on International Health, Education, and Environment, University of California at Los Angeles YVES BERGEVIN, Chief, Health Section, UNICEF, New York, New York DAVID CHALLONER (Institute of Medicine Foreign Secretary), Vice President for Health Affairs, University of Florida, Gainesville PATRICIA DANZON, Professor, Health Care Systems Development, University of Pennsylvania, Philadelphia RICHARD FEAC~M, Institute for Global Health, UC San Francisco/ UC Berkeley, San Francisco, California NOREEN GOLDMAN, Professor, Woodrow Wilson School of Public and International Affairs, Princeton University, Princeton, New Jersey MARGARET HAMBURG, Vice President for Biological Programs, Nuclear Threat Initiative, Washington, D.C. EILEEN KENNEDY, Deputy Undersecretary, Research, Education, and Economics, U.S. Department of Agriculture, Washington, D.C. GERALD KEUSCH (Liaison) Director, Fogarty International Center National Institutes of Health, Bethesda, Maryland ARTHUR KLE1NMAN, Maude and Lillian Presley Professor of Medical Anthropology/Professor of Psychiatry and Social Medicine, Harvard Medical School, Boston, Massachusetts ADEL MAHMOUD, President, Merck Vaccines, ~7hitehouse Station, New Jersey JOHN WON OWEN, Secretary, Nuffield Trust, London, United Kingdom ALLAN ROSENFIELD, Dean, Mailman School of Public Health. Columbia University, New York, New York SUSAN SCRIMSHAW, Dean, School of Public Health, University of Illinois at Chicago Staff JUDITH: BALE, Director PATRICIA CUFF, Research Associate STACEY KNOBLER, Study Director MAR]AN NAJAFI, Research Associate KATHERINE OBERHOLTZER, Project Assistant JASON PELLMAR, Project Assistant MARK SMOLINSKI, Study Director LAURIE SPINELLI, Project Assistant vial

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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 proce- dures approved by the National Research Council's Report Review Com- mittee. 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: Jon Andrus, University of California, San Francisco, CA Kenneth Bernard, Office of Senator Frist, U.S. Senate, Washington, D.C. David Heymann, World Health Organization, Geneva, Switzerland Walter Orenstein, Centers for Disease Control and Prevention, Atlanta, GA Murray Trostle, U.S. Agency for International Development, Washing- ton, D.C. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Charles Carpenter, M.D. Appointed by the National Research Council, he lX

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x REVIEWERS 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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PREFACE SUMMARY AND ASSESSMENT 70shua Lederberg 1 INTRODUCTION Ciro A. de Quadros Contents MAJOR EFFORTS FOR DISEASE ERADICATION Smallpox, 34 D.A. Henderson The Next Target After Polio: Global Eradication of Measles, 40 Stephen L. Cochi, Peter M. Strebel, Mark Papania, William /. Bellini, Walter A. Orenstein Eradication of Congenital Rubella Syndrome, 52 Stanley A. Plotkin Post-Polio Eradication: Issues and Challenges, 57 Walter R. Dowdie xv 1 22 33 3 BIOLOGICAL CHALLENGES TO POST-ERADICATION 64 Herd Immunity and the Design of Vaccination Programs, 65 Roy M. Anderson Error, Hubris, and Malice, 77 C. |. Peters Xl l

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. . It 4 CONTENTS Natural SIV Reservoirs and Human Zoonotic Risk: Challenges to Disease Eradication, 84 Beatrice H. Hahn Vaccine-Associated Cases Due to Immunization with Live Virus Vaccines, 90 Jeffrey I. Cohen OPERATIONAL AND INSTITUTIONAL CHALLENGES TO POST-ERA1;)ICATION 98 Revision of the International Health Regulations: Progress Report, 99 Mario Libel Disease Surveillance, Program Management, and Sustainment of Immunization Programs, 106 Donald S. Burke The Capacity of Public Health Services to Respond to an Outbreak in the Post-Eradication Era, 112 Car! E. Taylor Laboratory Security and Regulations Governing Viral Pathogens in a Post-Immunization Era, 116 Raymond H. Cypess, Frank P. Simione 5 MEDICAL INTERVENTION AND TECHNOLOGICAL SOLUTIONS The Polio Eradication Effort: Should Vaccine Eradication Be Next?, 122 Vincent R. Racaniello Antiviral Therapy in the Management of Post-Eradication Infectious Disease Outbreaks, 127 Richard[J. Whitley Potential Use of Cytokines and Antibody for Post-Exposure Prophylaxis in the Post-Eradication Era, 129 Diane E. Griffin The Potential Role of Probiotics and Microbial Ecology in Host Defense, 133 Susanna Cun~zingham-Rundlles 121 6 THE CHALLENGES TO POST-ERADICATION OUTBREAKS 141 Ready or Not: The U.S. Health Care System and Emerging Infections, 142 Kenneth D. Bloem Vaccines for Post-Elimination Contingencies, 149 Thomas P. Monath

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CONTENTS Strategic Priorities for Addressing Post-Eradication Outbreaks, 157 Robert P. Kadiec Understanding the Public and Media Response to an Outbreak, 163 Ann E. Norwood Post-Eradication Challenges in the Developing World, 169 Ellyn W. Ogdlen APPENDIXES A Glossary and Acronyms B Workshop Agenda C Forum Member and Speaker Biographies Xl 1! 173 183 190

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Preface The Forum on Emerging Infections was created in 1996 in response to a request from the Centers for Disease Control and Prevention and the National Institutes of Health. The goal of the Forum is to provide struc- tured opportunities for representatives from academia, industry, profes- sional and interest groups, and government] to examine and discuss scien- tific and policy issues that are of shared interest and that are specifically related to research and prevention, detection, and management of emerging infectious diseases. In accomplishing this task, the Forum provides the opportunity to foster the exchange of information and ideas, identify areas in need of greater attention, clarify policy issues by enhancing knowledge and identifying points of agreement, and inform decision makers about science and policy issues. The Forum seeks to illuminate issues rather than resolve them directly; hence, it does not provide advice or recommenda- tions on any specific policy initiative pending before any agency or organi- zation. Its strengths are the diversity of its membership and the contribu- tions of individual members expressed throughout the activities of the Forum. Representatives of federal agencies serve in an ex officio capacity. An ex officio member of a group is one who is a member automatically by virtue of holding a particular office or membership in another body. xv

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xv' PREFACE ABOUT THE WORKSHOP The legacy of smallpox eradication has removed the worIdwicle suffer- ~ng caused by this disease, has resulted in yearly savings of substantial financial resources that are no longer needed for its treatment and preven- tion, and has helped build consensus and confidence to expand eradication programs to other diseases. Since smallpox eradication, the science of eradi- cation has changed and with it, our definitions of what diseases are possible to eradicate. For example, many diseases, such as polio, measles, onchocer- ciasis, dracunculiasis, lymphatic filariasis, leprosy, and Chagas diseases, once thought not to be eradicable, are now targeted for elimination and subsequent eradication.2 These and other disease control experiences pro- vide strong evidence that with full implementation of an appropriate con- tro! strategy, disease transmission can be effectively interrupted, if not elimi- nated regionally and possibly eradicated globally. Among the vaccine-preventable diseases, concerted efforts are under- way to eliminate or eradicate several viral diseases. By 2002, it is antici- pated that wild type poliovirus transmission will be interrupted worldwide. The Pan American Health Organization (PAHO) in 1994 developed an enhanced measles vaccination strategy with the goal of measles elimination from the Western Hemisphere by 2000. While measles cases are still re- ported, PAHO's measles elimination strategy has been very effective in interrupting transmission and maintaining the absence of measles virus in >99°/O of the 12,000 reporting municipalities in the Americas. The interrup- tion of indigenous measles transmission in the Americas by the end of the year 2001 remains an attainable goal. The criteria for assessing eradicability of polio, measles, and other viral infections have been debated extensively. What is specifically not addressed are the relative desirability and feasibility, and the time required, for stop- ping immunizations. With the elimination and eradication of several viral diseases on the horizon, issues surrounding the cessation of immunization activities become exceedingly important. Resolution of the issues affecting when and how immunization and other prevention activities can be stopped in conjunction with disease eradication are paramount to domestic and 2In 1997, the Dahlem Workshop on the Eradication of Infectious Diseases defined several levels of deliberate efforts of disease control, including eradication, as follows: Control: re- duction of disease incidence, prevalence, morbidity, and mortality to acceptable levels; Elimi- nation of disease: reduction to zero incidence of disease in a defined geographic area; Elimina- tion of infection: reduction to zero incidence of infection caused by a specific agent in a defined geographic area; Eradication: permanent reduction to zero worldwide incidence of infection caused by a specific agent; Extinction: the specific agent no longer exists in nature or the laboratory. It is important to note that within the following authored papers there is some inconsistency among the interpretations of these definitions.

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PREFACE . . XVl! international public health agencies, pharmaceutical and vaccine manufac- turers, and security analysts. In an effort to better understand the dynamics of disease eradication and post-immunization policies, the Institute of Medicine (IOM)'s Forum on Emerging Infections hosted a two-day workshop (February 1-2, 2001) on The Consequences of Viral Disease Eradication. Through invited pre- sentations, pane! discussion, and open dialogue with workshop partici- pants, we explored the principles underlying the biological challenges, medi- cal interventions, and operational considerations for post-immunization strategies for vaccine-preventable viral diseases, and highlighted important efforts that may facilitate wise decision making. ORGANIZATION OF WORKSHOP SUMMARY This workshop summary report is prepared for the Forum membership in the name of the editors, with the assistance of staff and consultants, as an individually authored document. Sections of the workshop summary not specifically attributed to an individual reflect the views of the editors and not those of the Forum on Emerging Infections sponsors, or the Institute of Medicine. The contents of the unattributed sections are based on the pre- sentations and discussions that took place during the workshop. The workshop summary is organized within chapters as a topic-by- topic description of the presentations and discussions. Its purpose is to present lessons from relevant experience, delineate a range of pivotal issues and their respective problems, and put forth some potential responses as described by the workshop participants. The Summary and Assessment chapter discusses the core messages that emerged from the speakers' presen- tations and the ensuing discussions. Chapter 1 is an introduction and over- view of past disease eradication efforts and prospects for the future. Chap- ters 2 to 6 begin with overviews provided by the editors, followed by the edited presentations made by the invited speakers. Appendix A is a glossary and list of acronyms useful to the reacler. Appendix B presents the work- shop agenda. Forum member and speaker biographies are presented in Appendix C. Although this workshop summary provides an account of the indi- vidual presentations, it also reflects an important aspect of the Forum philosophy. The workshop functions as a dialogue among representatives from different sectors and presents their beliefs on which areas may merit further attention. However, the reader should be aware that the material presented here expresses the views and opinions of those participating in the workshop and not the deliberations of a formally constituted IOM study committee. These proceedings summarize only what participants

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xvlt! PREFACE stated in the workshop and are not intended to be an exhaustive explora- tion of the subject matter. ACKNOWLEDGMENTS The Forum on Emerging Infections and the IOM wish to express their warmest appreciation to the individuals and organizations who gave valu- able time to provide information and advice to the Forum through partici- pation in the workshop e The Forum is indebted to the IOM staff who contributed during the course of the workshop and the production of this workshop summary. On behalf of the Forum, I gratefully acknowledge the efforts led by Stacey Knobler and Jonathan Davis, who dedicated much effort and time to devel- oping this workshop's agenda and for their thoughtful and insightful ap- proach and skill in translating the workshop proceedings and discussion into this workshop summary. I would also like to thank the following IOM staff and consultants for their valuable contributions to this activity: Leslie Pray, Marjan Najafi, Laurie Spinelli, Judith Bale, Katherine Oberholtzer, Paige Baldwin, Jennifer Otten, Brett Marvin, Clyde Behney, Bronwyn Schrecker, Sally Stanfield, Francesca Moghari, Estelle Miller, and Beth Gyorgy. Finally, the Forum also thanks sponsors that supported this activity. Financial support for this project was provided by the U.S. Department of Health and Human Services' National Institutes of Health, Centers for Disease Control and Prevention, and the Food and Drug Administration; U.S. Department of Defense; U.S. Department of State; U.S. Agency for International Development; U.S. Department of Veterans Affairs; Abbott Laboratories; American Society for Microbiology; Bristol-Myers Squibb Company; Burroughs WelIcome Fund; Eli Lilly & Company; The Ellison Medical Foundation; Glaxo Welicome; F. Hoffmann-La Roche AG; Pfizer; SmithKline Beecham Corporation; and Wyeth-Ayerst Laboratories. The views presented in this workshop summary are those of the editors and workshop participants and are not necessarily those of the funding organi- zat~ons. Joshua Lederberg, Chair Forum on Emerging Infections