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.
The volume, which includes a description of the committee's methods for evaluating evidence and directions for future research, will be important reading for public health officials, pediatricians, researchers, and concerned parents.
- Adverse Effects of Pertussis and Rubella Vaccines
- Copyright
- Preface
- Acknowledgments
- Contents
- Adverse Effects of PERTUSSIS and RUBELLA Vaccines
- 1 Executive Summary
- METHODOLOGIC CONSIDERATIONS IN EVALUATING THE EVIDENCE
- SUMMARY AND CONCLUSIONS
- RESEARCH NEEDS
- 2 Histories of Pertussis and Rubella Vaccines
- PERTUSSIS VACCINES
- Epidemiology of Whooping Cough
- Clinical Description
- Diagnosis
- Complications
- Descriptive Epidemiology
- Nature of the Causative Organism, B. pertussis
- Major Milestones in the Development of Pertussis Vaccines
- Whole-Cell Vaccines
- Acellular Vaccines
- Brief History of the Controversy Pertaining to Adverse Events Following Pertussis Vaccination
- RUBELLA VACCINES
- Epidemiology of the Disease Rubella
- Clinical Description
- Diagnosis
- Complications
- Descriptive Epidemiology
- Nature of the Rubella Virus
- Major Milestones in the Development of Rubella Vaccines
- Brief History of the Controversy Pertaining to Adverse Events Following Rubella Vaccination
- REFERENCES
- 3 Methodologic Considerations in Evaluating the Evidence
- THE NATURE OF THE EVIDENCE
- QUESTIONS TO BE ADDRESSED
- (1) Can vaccine cause the adverse event?
- (2) How frequently does vaccine cause the event?
- (3) Did vaccination cause a particular case of the adverse event?
- THE BURDEN OF PROOF
- CATEGORIES OF EVIDENCE
- Experiments in Humans
- Randomized Controlled Trials
- Other Experimental Studies
- Experiments in Animals: Animal Models
- Controlled Epidemiologic Studies (Observational)
- Cohort Studies
- Case-Comparison Studies
- Other Controlled Studies
- Case Reports and Case Series
- Searching for Patterns
- Historical Comparisons
- Causation of the Individual Case
- Monitoring System for Adverse Events Following Immunization
- ASSESSMENT OF THE EVIDENCE
- Evaluation of Single Studies
- Integration of the Collective Results
- Meta-Analysis
- Considerations in Inferring Causality
- THE NATURE OF THE CONCLUSIONS
- Quantitation
- Resolution
- Uncertainty and Confidence
- Quality
- Comprehensiveness
- Neutrality
- Judgment
- SUMMARY OF THE EVIDENCE
- REFERENCES
- 4 Evidence Concerning Pertussis Vaccines and Central Nervous System Disorders, Including Infantile...
- INFANTILE SPASMS
- Clinical Description
- Descriptive Epidemiology
- History of Suspected Association with Pertussis Vaccines
- Evidence from Studies in Humans
- Case Reports and Case Series
- Controlled Epidemiologic Studies
- Summary
- Conclusion
- HYPSARRHYTHMIA
- Clinical Description
- Descriptive Epidemiology
- History of Suspected Association with Pertussis Vaccines
- Evidence from Studies in Humans
- Case Reports and Case Series
- Controlled Epidemiologic Studies
- Summary
- Conclusion
- ASEPTIC MENINGITIS
- Clinical Description
- Descriptive Epidemiology
- History of Suspected Association with Pertussis Vaccines
- Evidence from Studies in Humans
- Case Reports and Case Series
- Controlled Epidemiologic Studies
- Summary
- Conclusion
- ENCEPHALOPATHY
- Clinical Description
- Encephalopathy Following Whooping Cough
- Pathology
- Descriptive Epidemiology
- History of Suspected Association with Pertussis Vaccines
- Evidence from Studies in Humans
- Case Reports and Case Series
- Studies in Defined Populations
- The National Childhood Encephalopathy Study
- Other Controlled Studies in Humans
- Evidence from Studies in Animals
- Aluminum Salts
- Summary
- Conclusion
- 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
- Case Reports and Case Series
- Controlled Epidemiologic Studies
- SUMMARY
- CONCLUSION
- REFERENCES
- 6 Evidence Concerning Pertussis Vaccines and Other Illnesses and Conditions
- ANAPHYLAXIS
- Clinical Description and Pathologic Aspects
- History of Suspected Association with Pertussis Vaccines
- Evidence from Studies in Humans
- Case Reports and Controlled Epidemiologic Studies
- Evidence from Studies in Animals
- Endotoxin
- Summary
- Conclusion
- AUTISM
- Clinical Description
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Summary
- Conclusion
- ERYTHEMA MULTIFORME OR OTHER RASH
- Clinical Description
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Aluminum Salts
- Summary
- Conclusion
- GUILLAIN-BARRÉ SYNDROME (POLYNEUROPATHY)
- Clinical Description
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Summary
- Conclusion
- PERIPHERAL MONONEUROPATHY
- Clinical Description
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Summary
- Conclusion
- HEMOLYTIC ANEMIA
- Clinical Description
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Summary
- Conclusion
- JUVENILE DIABETES
- Clinical Description
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Controlled Epidemiologic Study
- Case Report
- Evidence from Studies in Animals
- Summary
- Conclusion
- LEARNING DISABILITIES AND HYPERACTIVITY
- Clinical Description
- Learning Disability, Reading Disability, and Dyslexia
- Hyperactivity, Hyperkinesis, and Attention Deficit Disorder
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Case Reports
- Controlled Epidemiologic Studies
- Summary
- Conclusion
- PROTRACTED INCONSOLABLE CRYING AND SCREAMING
- Clinical Description
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Case Reports and Case Series
- Controlled Epidemiologic Studies
- Summary
- Conclusions
- REYE SYNDROME
- Clinical Description
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Controlled Epidemiologic Study
- Case Reports and Case Series
- Summary
- Conclusion
- SHOCK AND ''UNUSUAL SHOCK-LIKE STATE" WITH HYPOTONICITY, HYPORESPONSIVENESS, AND SHORT-LIVED CONVULS ...
- Clinical Description
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Case Reports and Case Series
- Controlled Epidemiologic Studies
- Summary
- Conclusion
- THROMBOCYTOPENIA
- Clinical Description
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Case Reports and Case Series
- Summary
- Conclusion
- REFERENCES
- 7 Evidence Concerning Rubella Vaccines and Arthritis, Radiculoneuritis, and Thrombocytopenic Purpura
- ARTHRITIS
- Clinical Description and Pathologic Aspects
- Descriptive Epidemiology
- History of an Association with Rubella Vaccines
- Evidence from Studies in Humans
- Acute Arthropathy and Arthritis
- Chronic Arthritis
- Evidence from Studies in Animals
- Possible Mechanisms
- Summary
- Acute Arthropathy and Arthritis
- Chronic Arthritis
- Conclusions
- RADICULONEURITIS AND OTHER NEUROPATHIES
- Clinical Description
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Case Reports and Case Series
- Summary
- Conclusion
- THROMBOCYTOPENIC PURPURA
- Clinical Description
- Descriptive Epidemiology
- Evidence from Studies in Humans
- Summary
- Conclusion
- REFERENCES
- Afterword on Research Needs
- Bibliography
- Glossary of Terms B
- Appendixes
- A Strategies For Gathering Information: Adverse Effects of Pertussis and Rubella Vaccines
- LITERATURE SEARCHES
- OTHER SOURCES
- Reference Lists
- Presentations
- Public Meeting (January 10, 1990)
- Workshop (May 14, 1990)
- Committee Meeting (May 15, 1990)
- Additional Individuals and Organizations Who Provided Information
- Review of Interim Bibliography
- ABSTRACTION OF DATA FROM CASE REPORTS, CASE SERIES, AND CONTROLLED STUDIES
- Rationale
- Procedures for Abstraction and Adjudication of Study Data
- B Pertussis and Rubella Vaccines: A Brief Chronology
- PERTUSSIS VACCINES
- RUBELLA VACCINES
- REFERENCES
- C Animal Models for the Study of Whooping Cough and the Testing of Vaccine Materials
- ANIMAL MODELS FOR THE STUDY OF WHOOPING COUGH
- STANDARDIZED ANIMAL TESTS OF VACCINE MATERIALS
- REFERENCES
- D Technical Details of Power Calculations and Meta-Analyses
- POWER CALCULATIONS
- META-ANALYSES
- Formal Analysis
- Informal Analysis
- REFERENCES
- E Possible Involvement of Aluminum Salts in Erythema Multiforme, Encephalopathy, or Other Adverse E ...
- F Committee and Staff Biographies
- Index
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