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Protecting the Frontline in Biodefense Research: The Special Immunizations Program
PROTECTING THE FRONTLINE IN BIODEFENSE RESEARCH
The Special Immunizations Program
Committee on Special Immunizations Program for Laboratory Personnel Engaged in Research on Countermeasures for Select Agents
Board on Life Sciences
Division on Earth and Life Studies
NATIONAL RESEARCH COUNCIL
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program
THE NATIONAL ACADEMIES PRESS
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.
This project was supported by Contract HHSP23320042509XI (Task Order HHSP23337007T) between the National Academy of Sciences and the Department of Health and Human Services. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government.
International Standard Book Number-13: 978-0-309-20924-3
International Standard Book Number-10: 0-309-20924-2
Additional copies of this report are available from the
National Academies Press,
500 Fifth Street NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.
Copyright 2011 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America.
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program
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. Ralph J. Cicerone 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. Charles M. Vest 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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.
www.national-academies.org
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program
COMMITTEE ON SPECIAL IMMUNIZATIONS PROGRAM FOR LABORATORY PERSONNEL ENGAGED IN RESEARCH ON COUNTERMEASURES FOR SELECT AGENTS
DONALD S. BURKE (Chair), Dean,
Graduate School of Public Health; UPMC-Jonas Salk Chair in Global Health;
Associate Vice Chancellor
for Global Health; and
Director,
Center for Vaccine Research, University of Pittsburgh, Pittsburgh, Pennsylvania
W. EMMETT BARKLEY, President,
Proven Practices, Bethesda, Maryland
GERARDO CHOWELL, Assistant Professor,
School of Human Evolution and Social Change, Arizona State University;
Research Associate,
Fogarty International Center, U.S. National Institutes of Health, Tempe, Arizona
ALAN S. CROSS, Professor of Medicine,
Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland
STEPHEN W. DREW, President,
Drew Solutions LLC, Summit, New Jersey
KATHRYN M. EDWARDS, Sarah Sell Professor of Pediatrics; Director,
Vanderbilt Vaccine Research Program, Vanderbilt University, Nashville, Tennessee
ROBERT J. HAWLEY, Independent Consultant,
Biological Safety, Biosecurity and Biosurety Issues, Frederick, Maryland1
THOMAS G. KSIAZEK, Professor,
Department of Pathology and Department of Microbiology and Immunology;
Director,
National Biodefense Training Center;
Senior Staff Scientist and Director,
High Containment Operations Core, Galveston National Laboratory, University of Texas Medical Branch at Galveston, Galveston, Texas
THOMAS P. MONATH, Partner,
Pandemic and Biodefense Fund, Kleiner Perkins Caufield and Byers;
Adjunct Professor,
Harvard School of Public Health, Cambridge, Massachusetts
PETER A. PATRIARCA, Senior Clinical Consultant,
Biologics Consulting Group, Inc., Bethesda, Maryland
HOLLY A. TAYLOR, Assistant Professor,
Department of Health Policy and Management, Bloomberg School of Public Health;
Core Faculty,
Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland
THOMAS E. WALTON, Former Associate and Acting Deputy Administrator for Veterinary Services,
Animal and Plant Health Inspection Service, U.S. Department of Agriculture (retired), Eloy, Arizona
1
Senior Advisor, Science, Midwest Research Institute, Frederick, Maryland, until April 2011
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program
Staff
KATHERINE BOWMAN, Study Director and Senior Program Officer
ADAM FAGEN, Study Director and Senior Program Officer (until June 2010)
CARL-GUSTAV ANDERSON, Program Associate
NORMAN GROSSBLATT, Senior Editor
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program
BOARD ON LIFE SCIENCES
KEITH R. YAMAMOTO (Chair),
University of California, San Francisco, California
BONNIE L. BASSLER,
Princeton University, Princeton, New Jersey
VICKI L. CHANDLER,
Gordon and Betty Moore Foundation, Palo Alto, California
SEAN EDDY,
Howard Hughes Medical Institute, Janelia Farm Research Campus, Ashburn, Virginia
MARK D. FITZSIMMONS,
John D. and Catherine T. MacArthur Foundation, Chicago, Illinois
DAVID R. FRANZ,
Midwest Research Institute, Frederick, Maryland
DONALD E. GANEM,
University of California, San Francisco, California
LOUIS J. GROSS,
University of Tennessee, Knoxville, Tennessee
JO HANDELSMAN,
Yale University, New Haven, Connecticut
CATO T. LAURENCIN,
University of Connecticut Health Center, Farmington, Connecticut
BERNARD LO,
University of California, San Francisco, California
ROBERT M. NEREM,
Georgia Institute of Technology, Atlanta, Georgia
CAMILLE PARMESAN,
University of Texas, Austin, Texas
MURIEL E. POSTON,
Skidmore College, Saratoga Springs, New York
ALISON G. POWER,
Cornell University, Ithaca, New York
BRUCE W. STILLMAN,
Cold Spring Harbor Laboratory, Cold Spring Harbor, New York
CYNTHIA WOLBERGER,
Johns Hopkins University School of Medicine, Baltimore, Maryland
MARY WOOLLEY,
Research!America, Alexandria, Virginia
Staff
FRANCES E. SHARPLES, Director
JO L. HUSBANDS, Scholar/Senior Project Director
JAY B. LABOV, Senior Scientist/Program Director for Biology Education
KATHERINE BOWMAN, Senior Program Officer
MARILEE K. SHELTON-DAVENPORT, Senior Program Officer
INDIA HOOK-BARNARD, Program Officer
ANNA FARRAR, Financial Associate
CARL-GUSTAV ANDERSON, Program Associate
AMANDA MAZZAWI, Senior Program Assistant
SAYYEDA AYESHA AHMED, Senior Program Assistant
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program
Acknowledgments
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 the 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 of 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 thank the following individuals for their review of this report:
R. Mark Buller, Saint Louis University School of Medicine
Arturo Casadevall, Albert Einstein College of Medicine of Yeshiva University
Janet Garber, Garber Consulting, LLC
Adolfo García-Sastre, Mount Sinai School of Medicine
John Grabenstein, Merck & Co., Inc.
Barbara Johnson, Johnson & Associates, LLC
Gigi Kwik Gronvall, University of Pittsburgh Medical Center
Steven Projan, MedImmune
Pierre Rollin, Centers for Disease Control and Prevention
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 Adel Mahmoud, Princeton University. Appointed by the National Research Council, he was responsible
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program
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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Contents
SUMMARY
1
1
Introduction
7
1.1 The Current Context of Pathogen Research,
9
1.2 Categorization of Pathogens and Management of Pathogen Research,
10
1.3 Charge to the Committee,
15
1.4 Organization of the Report,
19
2
History of the Special Immunizations Program and Lessons Learned from Occupational Immunization Against Hazardous Pathogens
21
2.1 Historical Pathogen and Countermeasures Research and the Origins of the Special Immunizations Program,
21
2.2 The History of Vaccine Production for the Special Immunizations Program,
23
2.3 The Role of Immunization in Research with Hazardous Pathogens and Lessons Learned,
27
2.4 Lessons Learned from the Fort Detrick Occupational Health and Safety Programs,
39
2.5 Findings on Laboratory Infections,
41
3
The U.S. Medical Countermeasures Enterprise and Recent Reviews and Current Operation of the Special Immunizations Program
43
3.1 The U.S. Medical Countermeasures Enterprise,
43
3.2 National Biodefense and Medical Countermeasures Priorities,
46
3.3 Review of Previous Reports Relevant to Biodefense Medical Countermeasures,
48
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3.4 Recent Developments Regarding the Special Immunizations Program (2000–2010),
53
3.5 The Current Special Immunizations Program,
58
3.6 Findings and Conclusions on the Medical Countermeasures Enterprise and the Current Special Immunizations Program,
73
4
Regulations and Other Guidance Pertaining to the Development and Use of Vaccines in the Special Immunization Program
77
4.1 Overall Regulatory Framework for Vaccines,
78
4.2 Options for U.S. Licensure,
79
4.3 Administration of SIP Vaccines Under an Investigational New Drug Application,
84
4.4 Other Regulations and Guidance Offering Potential Incentives to the Developers of SIP Vaccines,
88
4.5 Regulatory Considerations: Looking Toward the Future,
89
4.6 Findings and Conclusions on Regulatory Pathways Applicable to the SIP,
94
5
New Vaccine Development and the Future Needs of the Special Immunizations Program
95
5.1 The Process of Vaccine Development,
95
5.2 New Vaccine Development and the Future Needs of the Special Immunizations Program,
96
5.3 The International Context of the Special Immunizations Program,
108
5.4 Cooperation with the Veterinary Community,
113
5.5 Findings and Conclusions Related to Future Vaccine Needs in the Special Immunizations Program,
113
6
Potential Options for the Special Immunizations Program and for Personnel Immunization
115
6.1 Options for the Future of the SIP,
116
6.2 Conclusion on Potential Options for the SIP,
128
7
Conclusions and Recommendations
129
7.1 The Role of Vaccines in Protecting Research Workers,
129
7.2 For Which Pathogens Would It Be Highly Desirable to Have a Vaccine, and Which Pathogens Should Receive Priority Attention?,
131
7.3 Advantages and Disadvantages of the Use of Investigational Vaccines as They Have Been Used in the Special Immunizations Program,
132
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7.4 Vaccine Development and Supply Within and Beyond the Existing Special Immunizations Program,
133
7.5 General Observations Regarding the Role of Immunizations in the Context of Research with Hazardous Pathogens,
134
REFERENCES
139
APPENDIXES
A Committee Member Biographies
151
B Abbreviations and Acronyms
159
C Glossary
163
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