Adverse Effects of Vaccines: Evidence and Causality

In 1900, for every 1,000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The National Childhood Vaccine Injury Act, passed in 1986, was intended to bolster vaccine research and development through the federal coordination of vaccine initiatives and to provide relief to vaccine manufacturers facing financial burdens. The legislation also intended to address concerns about the safety of vaccines by instituting a compensation program, setting up a passive surveillance system for vaccine adverse events, and by providing information to consumers. A key component of the legislation required the U.S. Department of Health and Human Services to collaborate with the Institute of Medicine to assess concerns about the safety of vaccines and potential adverse events, especially in children.

Adverse Effects of Vaccines reviews the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the National Vaccine Injury Compensation Program (VICP), including the varicella zoster vaccine, influenza vaccines, the hepatitis B vaccine, and the human papillomavirus vaccine, among others. For each possible adverse event, the report reviews peer-reviewed primary studies, summarizes their findings, and evaluates the epidemiological, clinical, and biological evidence. It finds that while no vaccine is 100 percent safe, very few adverse events are shown to be caused by vaccines. In addition, the evidence shows that vaccines do not cause several conditions. For example, the MMR vaccine is not associated with autism or childhood diabetes. Also, the DTaP vaccine is not associated with diabetes and the influenza vaccine given as a shot does not exacerbate asthma.

Adverse Effects of Vaccines will be of special interest to the National Vaccine Program Office, the VICP, the Centers for Disease Control and Prevention, vaccine safety researchers and manufacturers, parents, caregivers, and health professionals in the private and public sectors.

• Front Matter
• Summary
• 1 Introduction
• 2 Approach
• 3 Evaluating Biological Mechanisms of Adverse Events
• 4 Measles, Mumps, and Rubella Vaccine
• 5 Varicella Virus Vaccine
• 6 Influenza Vaccine
• 7 Hepatitis A Vaccine
• 8 Hepatitis B Vaccine
• 9 Human Papillomavirus Vaccine
• 10 Diphtheria Toxoid, Tetanus Toxoid, and Acellular PertussisContaining Vaccines
• 11 Meningococcal Vaccine
• 12 Injection-Related Adverse Events
• 13 Concluding Comments
• Appendix A: Glossary
• Appendix B: List of Adverse Events
• Appendix C: Literature Search Strategy
• Appendix D: Causality Conclusion Tables
• Appendix E: References
• Appendix F: Committee Biosketches
• Appendix G: Meeting Agendas
• Index