Immunization to protect infants and children from vaccine-preventable diseases is one of the greatest achievements of public health. Immunization is not without risks, however. It is well established, for example, that the oral polio vaccine can on rare occasion cause paralytic polio.

The Immunization Safety Review Committee was established by the Institute of Medicine (IOM) to evaluate the available evidence on a series of immunization safety concerns. The committee is charged with examining three immunization safety hypotheses each year during the three-year study period (2001- 2003). While all of the committee members share the view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group. In this report, which is the fourth in the series, the committee examines the hypothesis that the hepatitis B vaccine increases the risk for demyelinating disorders of the central or peripheral nervous systems, including multiple sclerosis (MS) and Guillain-Barré syndrome (GBS).

Contents

• THE NATIONAL ACADEMIES
• IMMUNIZATION SAFETY REVIEW COMMITTEE
• REVIEWERS
• Foreword
• Acknowledgments
• Executive Summary
  • ABSTRACT
  • DEMYELINATING NEUROLOGICAL DISORDERS
  • HEPATITIS B VIRAL INFECTION
  • HEPATITIS B VACCINE
  • EVIDENCE REVIEWED BY THE COMMITTEE
  • CAUSALITY ASSESSMENT
  • BIOLOGICAL MECHANISMS ASSESSMENT
  • SIGNIFICANCE ASSESSMENT
  • RECOMMENDATIONS FOR PUBLIC HEALTH RESPONSE
  • REFERENCES
• Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders
  • THE CHARGE TO THE COMMITTEE
  • THE STUDY PROCESS
  • THE FRAMEWORK FOR SCIENTIFIC ASSESSMENT
  • UNDER REVIEW: HEPATITIS B VACCINE AND DEMYELINATING NEUROLOGICAL DISORDERS
  • SCIENTIFIC ASSESSMENT
  • SIGNIFICANCE ASSESSMENT
  • RECOMMENDATIONS FOR PUBLIC HEALTH RESPONSE
  • SUMMARY
  • REFERENCES
• Appendix A Committee Conclusions and Recommendations from Previous Reports
• Appendix B Public Meeting Agenda March 11, 2002
• Appendix C Chronology of Important Events Regarding Vaccine Safety

Support for this project was provided by the Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health as part of a National Institutes of Health Task Order No. 74. The views presented in this report are those of the Institute of Medicine Immunization Safety Review Committee and are not necessarily those of the funding agencies.

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.