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Executive Summary

Next to clean water, no single intervention has had so profound an effect on reducing mortality from childhood diseases as has the widespread introduction of vaccines. Immunization, the process in which the body's own protective mechanisms are primed to thwart the invasion or multiplication of pathogens, is effective and relatively inexpensive, simple, and easy to deliver.

The use of vaccines is not entirely without risk, however. Vaccines, including the whole-cell pertussis (whooping cough) vaccine and the rubella (German measles) vaccine, the subjects of this report, typically contain small quantities of material derived from disease-causing organisms. The pertussis vaccine contains dead bacteria and is termed a killed or inactivated vaccine; the rubella vaccine contains laboratory-weakened live viruses and is termed a live, attenuated vaccine.

This study responds to a request to the Institute of Medicine (IOM) to conduct a thorough review of the evidence pertaining to a set of serious adverse events and immunization with pertussis or rubella vaccine. The request to IOM originated in the 1986 National Childhood Vaccine Injury Act (Public Law 99-660), whose primary purpose was to establish a federal compensation scheme for persons potentially injured by a vaccine. Section 312 of Public Law 99-660 called for IOM review of scientific and other information on specific adverse consequences of pertussis and rubella vaccines. The 11-member interdisciplinary committee, constituted



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