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Suggested Citation:"Front Matter." National Research Council. 2011. Protecting the Frontline in Biodefense Research: The Special Immunizations Program. Washington, DC: The National Academies Press. doi: 10.17226/13112.
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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

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

Suggested Citation:"Front Matter." National Research Council. 2011. Protecting the Frontline in Biodefense Research: The Special Immunizations Program. Washington, DC: The National Academies Press. doi: 10.17226/13112.
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THE NATIONAL ACADEMIES PRESS
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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.

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Suggested Citation:"Front Matter." National Research Council. 2011. Protecting the Frontline in Biodefense Research: The Special Immunizations Program. Washington, DC: The National Academies Press. doi: 10.17226/13112.
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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. 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

Suggested Citation:"Front Matter." National Research Council. 2011. Protecting the Frontline in Biodefense Research: The Special Immunizations Program. Washington, DC: The National Academies Press. doi: 10.17226/13112.
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Suggested Citation:"Front Matter." National Research Council. 2011. Protecting the Frontline in Biodefense Research: The Special Immunizations Program. Washington, DC: The National Academies Press. doi: 10.17226/13112.
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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

Suggested Citation:"Front Matter." National Research Council. 2011. Protecting the Frontline in Biodefense Research: The Special Immunizations Program. Washington, DC: The National Academies Press. doi: 10.17226/13112.
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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

Suggested Citation:"Front Matter." National Research Council. 2011. Protecting the Frontline in Biodefense Research: The Special Immunizations Program. Washington, DC: The National Academies Press. doi: 10.17226/13112.
×

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

Page viii Cite
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Suggested Citation:"Front Matter." National Research Council. 2011. Protecting the Frontline in Biodefense Research: The Special Immunizations Program. Washington, DC: The National Academies Press. doi: 10.17226/13112.
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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

Suggested Citation:"Front Matter." National Research Council. 2011. Protecting the Frontline in Biodefense Research: The Special Immunizations Program. Washington, DC: The National Academies Press. doi: 10.17226/13112.
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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.

Suggested Citation:"Front Matter." National Research Council. 2011. Protecting the Frontline in Biodefense Research: The Special Immunizations Program. Washington, DC: The National Academies Press. doi: 10.17226/13112.
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Suggested Citation:"Front Matter." National Research Council. 2011. Protecting the Frontline in Biodefense Research: The Special Immunizations Program. Washington, DC: The National Academies Press. doi: 10.17226/13112.
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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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The U.S. Army's Special Immunizations Program is an important component of an overall biosafety program for laboratory workers at risk of exposure to hazardous pathogens. The program provides immunizations to scientists, laboratory technicians and other support staff who work with certain hazardous pathogens and toxins. Although first established to serve military personnel, the program was expanded through a cost-sharing agreement in 2004 to include other government and civilian workers, reflecting the expansion in biodefense research in recent years. Protecting the Frontline in Biodefense Research examines issues related to the expansion of the Special Immunizations Program, considering the regulatory frameworks under which the vaccines are administered, how additional vaccines might be considered for inclusion in the Program, and factors that might influence the development and manufacturing of vaccines for the Special Immunizations Program.

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