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surrounding the MMR-autism question. Since the late 1990s, this hypothesis has received increasing attention from scientific researchers, Congress, the media, parents, advocacy organizations, public health professionals, and vaccine manufacturers (60 Minutes, 2000; U.S. House Committee on Government Reform, 2000; Wakefield et al., 1998, 2000).

ORIGINS OF THE IMMUNIZATION SAFETY REVIEW PROJECT

The federal government has responded to concerns about the safety of vaccines through several mechanisms. In 1986, Congress passed the National Childhood Vaccine Injury Act (Public Law 99-660), followed by the Vaccine Compensation Amendments of 1987 (Public Law 100-203). This legislation mandated the establishment of a National Vaccine Injury Compensation Program to handle related claims, and of the Vaccine Adverse Event Reporting System (VAERS), which is a national passive surveillance system. The legislation also provided for the development of vaccine information statements for parents of children receiving immunizations. These activities are managed by three agencies of the U.S. Department of Health and Human Services (DHHS): the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Health Resources and Services Administration (HRSA). The compensation program is jointly administered by HRSA and the Department of Justice.

The legislation also called for the Institute of Medicine (IOM) to review evidence regarding possible adverse consequences of childhood immunizations. The three expert committees convened by IOM produced the reports Adverse Effects of Pertussis and Rubella Vaccines (IOM, 1991), Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality (IOM, 1994a), and DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis (IOM, 1994b). Following the completion of the third study, IOM was asked to organize the Vaccine Safety Forum to provide a framework for continued discussion of vaccine safety issues. Forum participants included representatives of government agencies, advocacy groups, and pharmaceutical companies, as well as parents, health care providers, academic researchers, and IOM staff. Forum discussions, on topics such as research strategies and risk communication, were documented in brief reports (IOM, 1996, 1997a,b) but were not intended to produce conclusions or recommendations. The final meeting of the Forum explored the early emerging data regarding the hypothesized relationship between MMR vaccine and autism. A list of research ideas from that open meeting can be found in Appendix D.

In 1995 and 1997, in response to the findings and recommendations of Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality (IOM, 1994a), the Secretary of the DHHS updated the Vaccine Injury Table, a list of post-vaccination events that must be reported to DHHS and that



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