An Assessment of the Safety of the Anthrax Vaccine

A Letter Report

Committee on Health Effects Associated with Exposures During the Gulf War

INSTITUTE OF MEDICINE
Washington, D.C.



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An Assessment of the Safety of the Anthrax Vaccine: A Letter Report An Assessment of the Safety of the Anthrax Vaccine A Letter Report Committee on Health Effects Associated with Exposures During the Gulf War INSTITUTE OF MEDICINE Washington, D.C.

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An Assessment of the Safety of the Anthrax Vaccine: A Letter Report INSTITUTE OF MEDICINE 2101 Constitution Avenue, N.W. Washington, DC 20418 NOTICE: Preparation of this report was approved by William Colglazier, Executive Officer of the National Research Council, on behalf of its Governing Board, 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 on Health Effects Associated with Exposures During the Gulf War, which are responsible for the report, were chosen for their special competences and with regard for appropriate balance. This work is supported by the U.S. Army Medical Research and Material Command under Contract No. DAMD17-00-C-003. The views, opinions, and/or findings contained in this report are those of the Institute of Medicine Committee on Health Effects Associated with Exposures During the Gulf War and should not be construed as an official Department of the Army position, policy, or decision unless so designated by other documentation. Additional copies of this letter report are available in limited quantities from the Division of Health Promotion and Disease Prevention, Institute of Medicine, 2101 Constitution Avenue, N.W., Washington, DC 20418. The full text of this letter report is available on line at www.nap.edu/readingroom. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2000 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 image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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An Assessment of the Safety of the Anthrax Vaccine: A Letter Report THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council 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. William 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. Kenneth I.Shine 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. William A.Wulf are chairman and vice chairman, respectively, of the National Research Council.

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An Assessment of the Safety of the Anthrax Vaccine: A Letter Report COMMITTEE ON HEALTH EFFECTS ASSOCIATED WITH EXPOSURES DURING THE GULF WAR HAROLD C.SOX, Jr. (Chair), Professor and Chair, Department of Medicine, Dartmouth-Hitchcock Medical Center MICHAEL ASCHNER, Professor, Department of Physiology and Pharmacology, Wake Forest University School of Medicine PATRICIA A.BUFFLER, Professor of Epidemiology, University of California at Berkeley School of Public Health LUCIO GUIDO COSTA, Professor, Department of Environmental Health, University of Washington FIRDAUS DHABHAR, Assistant Professor, College of Dentistry, The Ohio State University ANTHONY L.KOMAROFF, Professor of Medicine, Harvard Medical School, and Editor-in-Chief, Harvard Medical Publications JANICE L.KRUPNICK, Professor, Department of Psychiatry, Georgetown University HERBERT LOWNDES, Professor, College of Pharmacy, Rutgers University ERNEST L.MAZZAFERRI, Emeritus Professor and Chairman, Department of Internal Medicine, The Ohio State University DEMETRIOS J.MOSCHANDREAS, Professor, Department of Environmental Engineering, Illinois Institute of Technology CHARLES E.PHELPS, Provost, University of Rochester SAMUEL J.POTOLICCHIO, Professor, Department of Neurology, George Washington University Medical Center JEAN REGAL, Professor, Department of Pharmacology, School of Medicine, University of Minnesota at Duluth MARC SCHENKER, Professor, Epidemiology and Preventive Medicine, University of California at Davis School of Medicine PETER H.SCHUR, Professor of Medicine, Harvard University, Brigham and Women’s Hospital FRANCOISE SEILLIER-MOISEIWITSCH, Associate Professor, Department of Biostatistics, University of North Carolina School of Public Health WALTER C.WILLETT, Professor and Chairman, Department of Nutrition, Harvard University School of Public Health SCOTT L.ZEGER, Professor and Chair, Department of Biostatistics, Johns Hopkins University School of Public Health Staff CAROLYN E.FULCO, Study Director CATHARYN T.LIVERMAN, Study Director SANDRA AU, Research Assistant KYSA CHRISTIE, Senior Project Assistant ROSE MARIE MARTINEZ, Director, Division of Health Promotion and Disease Prevention

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An Assessment of the Safety of the Anthrax Vaccine: A Letter Report INDEPENDENT REPORT 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 National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the Institute of Medicine in making the 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. The committee wishes to thank the following individuals for their participation in the review of this report: Donald A.Henderson, Johns Hopkins University Richard Johnston, University of Colorado Joyce Lashof, University of California, Berkeley Robert Miller, (retired) National Cancer Institute Gregory Poland, Mayo Clinic and Foundation Hugh Tilson, University of North Carolina at Chapel Hill Mary Wilson, Mount Auburn Hospital, Cambridge, MA While the individuals listed above have provided constructive comments and suggestions, responsibility for the final content of this report rests solely with the authoring committee and the Institute of Medicine.