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CDC Anthrax Vaccine Safety & Efficacy Research Program Interim Report rf"J INSTITUTE OF MEDICINE

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NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 NOTICE: The project that is the subject of this report was approver! 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 regarc} for appropriate balance. Support for this project was proviciec} by the Centers for Disease Control and Prevention, Department of Health and Human Services (Contract No. 200-2000-00629~. The views presented in this report are those of the Institute of Medicine Committee to Review the CDC Anthrax Vaccine Safety ant! Efi icacy Research Program and are not necessarily those of the funding agencies. Additional copies of this report are available for sale from the National Academy Press, 2 ~ O 1 Constitution Avenue, N.W., Box 285, Washington, D.C. 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP's home page at The full text of this report is available at For more information about the Institute of Medicine, visit the IOM home page at: Copyright 2001 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. Inking is not enough; we must To. Goethe INSTI UT or, OF MEDIC Shaping the Future for Health NE

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National Academy of Sciences National Academy of Engineering institute of Medicine National Research Council ax ..f ~ A.... ~ is. :~ s ~~.~:...~. a..) The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, clecticated to the furtherance of science and tech- nology and to their use for the general welfare. Upon the authority of the charter granted to it by the Con- gress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific ant! technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was establisher! in 1964, under the charter of the National AcacI- emy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administra- tion and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the fecleral government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education ant! research, and recognizes the supe- rior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineer- ~ng. 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 Sci- ences 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. Kenneth I. Shine is president of the Insti- tute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associ- ate the broad community of science and technology with the Academy's purposes of furthering knowI- ecige 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, ant! the scientific and engineering communities. The Council is administered jointly by both Academies ant! the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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COMMITTEE TO REVIEW THE CDC ANTHRAX VACCINE SAFETY AND EFFICACY RESEARCH PROGRAM PHILIP BRACHMAN (Chair), Professor, Department of International Health, Rollins School of Public Health (RSPH), Emory University. ADAORA AI~ISE ADIMORA, Assistant Professor of Medicine and Clinical Assistant Profes- sor of Epidemiology at the University of North Carolina School of Medicine in Chapel Hill. TRUDY BUSH, Professor and Director of the Graduate Program in the Department of Epide- miology and Preventive Medicine at the University of Maryland School of Medicine. THEODORE C. EICHOFF, Professor of Medicine, Division of Infectious Disease, University of Colorado Health Sciences Center. PATRICIA FERRIERI, Professor of Laboratory Medicine arid Pathology, aIld Pediatrics, and Director of the Clinical Microbiology Laboratory at the University of Minnesota Medical School. EMIL C. GOTSCHLICH,l Vice President for Medical Sciences at The Rockefeller University, R. Gwin Follis-Chevron Professor, and head of the Laboratory of Bacterial Pathogenesis and Immunology. MAURICE HILLEMAN, Director, Merck Institute, and Adjunct Professor of Pediatrics, Uni- versity of Pennsylvania School of Medicine. DENNIS KASPER,l Executive Dean for Academic Programs, William Ellery Channing Pro- fessor of Medicine, Professor of Microbiology and Molecular Genetics at Harvard Medical School, Director of the Channing Laboratory, and a senior physician at Brigham and Women's Hospital. REGINA RABINOVICH, Director, Malaria Vaccine Initiative, Program for Appropriate Tech- nology in Health (PATH). BRIAN L. STROM,l Chair and Professor of Biostatistics & Epidemiology, Professor of Medi- cine, Professor of Pharmacology, Director of the Center for Clinical Epidemiology & Biostatis- tics, and Chair of the Graduate Group in Epidemiology & Biostatistics, University of Pennsylva- nia School of Medicine. HUGH H. TILSON,l Clinical Professor of Epidemiology and Health Policy and Senior Advisor to the Dean at the University of North Carolina School of Public Health. Staff LEE ZWANZIGER, Senior Program Officer (Study Director) LOIS JOELLENBECK, Senior Program Officer KAREN KAZMERZAK, Research Assistant PHILLIP BAILEY, Project Assistant RICHARD MILLER, Director, Medical Follow-Up Agency * Through March 2001. Also serving on related IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine v

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BOARD OF THE MEDICAL FOLLOW-UP AGENCY JOHN C. BAlLAR ITI, Professor Emeritus, Health Studies, University of Chicago. GILBERT W. BEEBE, Head, Chornoby] Research Unit, Radiation Epidemiology Branch, Na- tional Cancer institute, National Institutes of Health. DAN G. BLAZER, J.P. Gibbons Professor of Psychiatry, Duke University Meclical Center. GERMAINE BUCK, Chief, Epidemiology Branch, Division of Epidemiology, Statistics & Pre- vention, National Institute of Chilct Health & Human Development, National Institutes of Health. DANIEL H. FREEMAN, Jr., Professor ant! Director, Office of Biostatistics, University of Texas Medical Branch. IRVING I. GOTTESMAN, Sherrell J. Aston Professor of Psychology, Professor of Clinical Pediatrics, University of Virginia. THOMAS A. LOUIS, Senior Statistical Scientist, The RAND Corporation NANCY MUELLER, Professor, Department of Epidemiology, Harvard School of Public Health. PHILIP K. RUSSELL, Professor Emeritus, Department of International Health, Johns Hopkins School of Hygiene and Public Health. G. MARIE SWANSON, Director, Cancer Center, ant! Professor, Department of Family Practice and Medicine, Michigan State University. V1 7