Parents have come to depend on vaccines to protect their children from a variety of diseases. Some evidence suggests, however, that vaccination against pertussis (whooping cough) and rubella (German measles) is, in a small number of cases, associated with increased risk of serious illness.

This book examines the controversy over the evidence and offers a comprehensively documented assessment of the risk of illness following immunization with vaccines against pertussis and rubella. Based on extensive review of the evidence from epidemiologic studies, case histories, studies in animals, and other sources of information, the book examines:

• The relation of pertussis vaccines to a number of serious adverse events, including encephalopathy and other central nervous system disorders, sudden infant death syndrome, autism, Guillain-Barre syndrome, learning disabilities, and Reye syndrome.
• The relation of rubella vaccines to arthritis, various neuropathies, and thrombocytopenic purpura.

Contents

• COMMITTEE TO REVIEW THE ADVERSE CONSEQUENCES OF PERTUSSIS AND RUBELLA VACCINES
• Preface
• Acknowledgments
• 1. Executive Summary
  • METHODOLOGIC CONSIDERATIONS IN EVALUATING THE EVIDENCE
  • SUMMARY AND CONCLUSIONS
  • RESEARCH NEEDS
• 2. Histories of Pertussis and Rubella Vaccines
  • PERTUSSIS VACCINES
  • RUBELLA VACCINES
  • REFERENCES
• 3. Methodologic Considerations in Evaluating the Evidence
  • THE NATURE OF THE EVIDENCE
  • QUESTIONS TO BE ADDRESSED
  • THE BURDEN OF PROOF
  • CATEGORIES OF EVIDENCE
  • ASSESSMENT OF THE EVIDENCE
  • THE NATURE OF THE CONCLUSIONS
  • SUMMARY OF THE EVIDENCE
  • REFERENCES
• 4. Evidence Concerning Pertussis Vaccines and Central Nervous System Disorders, Including Infantile Spasms, Hypsarrhythmia, Aseptic Meningitis, and Encephalopathy
  • INFANTILE SPASMS
  • HYPSARRHYTHMIA
  • ASEPTIC MENINGITIS
  • ENCEPHALOPATHY
  • REFERENCES
• 5. Evidence Concerning Pertussis Vaccines and Deaths Classified as Sudden Infant Death Syndrome
  • CLINICAL DESCRIPTION, DIAGNOSIS, AND PATHOLOGY
  • DESCRIPTIVE EPIDEMIOLOGY
  • HISTORY OF SUSPECTED ASSOCIATION WITH PERTUSSIS VACCINES
  • EVIDENCE FROM STUDIES IN HUMANS
  • SUMMARY
  • CONCLUSION
  • REFERENCES
• 6. Evidence Concerning Pertussis Vaccines and Other Illnesses and Conditions
  • ANAPHYLAXIS
  • AUTISM
  • ERYTHEMA MULTIFORME OR OTHER RASH
  • GUILLAIN-BARRÉ SYNDROME (POLYNEUROPATHY)
  • PERIPHERAL MONONEUROPATHY
  • HEMOLYTIC ANEMIA
  • JUVENILE DIABETES
  • LEARNING DISABILITIES AND HYPERACTIVITY
  • PROTRACTED INCONSOLABLE CRYING AND SCREAMING
  • REYE SYNDROME
  • SHOCK AND ''UNUSUAL SHOCK-LIKE STATE" WITH HYPOTONICITY, HYPORESPONSIVENESS, AND SHORT-LIVED CONVULSIONS, USUALLY FEBRILE
  • THROMBOCYTOPENIA
  • REFERENCES
• 7. Evidence Concerning Rubella Vaccines and Arthritis, Radiculoneuritis, and Thrombocytopenic Purpura
  • ARTHRITIS
  • RADICULONEURITIS AND OTHER NEUROPATHIES
  • THROMBOCYTOPENIC PURPURA
  • REFERENCES
• Afterword on Research Needs
• Bibliography
• Glossary of Terms
• Appendixes
  • A Strategies For Gathering Information: Adverse Effects of Pertussis and Rubella Vaccines
  • B Pertussis and Rubella Vaccines: A Brief Chronology
  • C Animal Models for the Study of Whooping Cough and the Testing of Vaccine Materials
  • D Technical Details of Power Calculations and Meta-Analyses
  • E Possible Involvement of Aluminum Salts in Erythema Multiforme, Encephalopathy, or Other Adverse Events After Pertussis Immunization
  • F Committee and Staff Biographies

The project was supported by funds coordinated through the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (contract no. NO1-AI-95041).

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 report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this the Institute acts under the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Samuel O. Thier is President of the Institute of Medicine.