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.

Contents

• THE NATIONAL ACADEMIES
• COMMITTEE ON SPECIAL IMMUNIZATIONS PROGRAM FOR LABORATORY PERSONNEL ENGAGED IN RESEARCH ON COUNTERMEASURES FOR SELECT AGENTS
• BOARD ON LIFE SCIENCES
• Acknowledgments
• Summary
• 1. Introduction
  • 1.1 THE CURRENT CONTEXT OF PATHOGEN RESEARCH
  • 1.2 CATEGORIZATION OF PATHOGENS AND MANAGEMENT OF PATHOGEN RESEARCH
  • 1.3 CHARGE TO THE COMMITTEE
  • 1.4 ORGANIZATION OF THE REPORT
• 2. History of the Special Immunizations Program and Lessons Learned from Occupational Immunization Against Hazardous Pathogens
  • 2.1 HISTORICAL PATHOGEN AND COUNTERMEASURES RESEARCH AND THE ORIGINS OF THE SPECIAL IMMUNIZATIONS PROGRAM
  • 2.2 THE HISTORY OF VACCINE PRODUCTION FOR THE SPECIAL IMMUNIZATIONS PROGRAM
  • 2.3 THE ROLE OF IMMUNIZATION IN RESEARCH WITH HAZARDOUS PATHOGENS AND LESSONS LEARNED
  • 2.4 LESSONS LEARNED FROM THE FORT DETRICK OCCUPATIONAL HEALTH AND SAFETY PROGRAMS
  • 2.5 FINDINGS ON LABORATORY INFECTIONS
• 3. The U.S. Medical Countermeasures Enterprise and Recent Reviews and Current Operation of the Special Immunizations Program
  • 3.1 THE U.S. MEDICAL COUNTERMEASURES ENTERPRISE
  • 3.2 NATIONAL BIODEFENSE AND MEDICAL COUNTERMEASURES PRIORITIES
  • 3.3 REVIEW OF PREVIOUS REPORTS RELEVANT TO BIODEFENSE MEDICAL COUNTERMEASURES
  • 3.4 RECENT DEVELOPMENTS REGARDING THE SPECIAL IMMUNIZATIONS PROGRAM (2000–2010)
  • 3.5 THE CURRENT SPECIAL IMMUNIZATIONS PROGRAM
  • 3.6 FINDINGS AND CONCLUSIONS ON THE MEDICAL COUNTERMEASURES ENTERPRISE AND THE CURRENT SPECIAL IMMUNIZATIONS PROGRAM
• 4. Regulations and Other Guidance Pertaining to the Development and Use of Vaccines in the Special Immunizations Program
  • 4.1 OVERALL REGULATORY FRAMEWORK FOR VACCINES
  • 4.2 OPTIONS FOR U.S. LICENSURE
  • 4.3 ADMINISTRATION OF SIP VACCINES UNDER AN INVESTIGATIONAL NEW DRUG APPLICATION
  • 4.4 OTHER REGULATIONS AND GUIDANCE OFFERING POTENTIAL INCENTIVES TO THE DEVELOPERS OF SIP VACCINES
  • 4.5 REGULATORY CONSIDERATIONS: LOOKING TOWARD THE FUTURE
  • 4.6 FINDINGS AND CONCLUSIONS ON REGULATORY PATHWAYS APPLICABLE TO THE SIP
• 5. New Vaccine Development and the Future Needs of the Special Immunizations Program
  • 5.1 THE PROCESS OF VACCINE DEVELOPMENT
  • 5.2 NEW VACCINE DEVELOPMENT AND THE FUTURE NEEDS OF THE SPECIAL IMMUNIZATIONS PROGRAM
  • 5.3 THE INTERNATIONAL CONTEXT OF THE SPECIAL IMMUNIZATIONS PROGRAM
  • 5.4 COOPERATION WITH THE VETERINARY COMMUNITY
  • 5.5 FINDINGS AND CONCLUSIONS RELATED TO FUTURE VACCINE NEEDS IN THE SPECIAL IMMUNIZATIONS PROGRAM
• 6. Potential Options for the Special Immunizations Program and for Personnel Immunization
  • 6.1 OPTIONS FOR THE FUTURE OF THE SIP
  • 6.2 CONCLUSION ON POTENTIAL OPTIONS FOR THE SIP
• 7. Conclusions and Recommendations
  • 7.1 THE ROLE OF VACCINES IN PROTECTING RESEARCH WORKERS
  • 7.2 FOR WHICH PATHOGENS WOULD IT BE HIGHLY DESIRABLE TO HAVE VACCINES, AND WHICH PATHOGENS SHOULD RECEIVE PRIORITY ATTENTION?
  • 7.3 ADVANTAGES AND DISADVANTAGES OF THE USE OF INVESTIGATIONAL VACCINES AS THEY HAVE BEEN USED IN THE SPECIAL IMMUNIZATIONS PROGRAM
  • 7.4 VACCINE DEVELOPMENT AND SUPPLY WITHIN AND BEYOND THE EXISTING SPECIAL IMMUNIZATIONS PROGRAM
  • 7.5 GENERAL OBSERVATIONS REGARDING THE ROLE OF IMMUNIZATIONS IN THE CONTEXT OF RESEARCH WITH HAZARDOUS PATHOGENS
• References
• Appendixes
  • Appendix A Committee Member Biographies
  • Appendix B Abbreviations and Acronyms
  • Appendix C Glossary

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.

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.