nized the need for an independent, expert group to address immunization safety in a timely and objective manner. The IOM has been involved in such issues since the 1970s. (A brief chronology can be found in Appendix D.) In 1999, because of IOM’s previous work and its access to independent scientific experts, CDC and NIH began a year of discussions with IOM to develop the Immunization Safety Review project, which would address both existing and emerging vaccine safety issues.

The Immunization Safety Review Committee is responsible for examining a broad variety of immunization safety concerns. Committee members have expertise in pediatrics, neurology, immunology, internal medicine, infectious diseases, genetics, epidemiology, biostatistics, risk perception and communication, decision analysis, public health, nursing, and ethics. While all of the committee members share the view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group. Additional discussion of the committee composition can be found in the Foreword, written by Dr. Harvey Fineberg, President of the IOM.

The committee was charged with examining up to three immunization safety hypotheses each year during the three-year study period (2001-2003). These hypotheses were selected by the Interagency Vaccine Group (IAVG), whose members represent several units of the Department of Health and Human Services: the CDC’s National Vaccine Program Office, National Immunization Program, and National Center for Infectious Diseases; the NIH’s National Institute of Allergy and Infectious Diseases; the Food and Drug Administration (FDA); the Health Resources and Services Administration’s National Vaccine Injury Compensation Program; and the Centers for Medicare & Medicaid Services. The IAVG includes representation from the Department of Defense and the Agency for International Development as well. The committee has issued seven previous reports on vaccine safety issues over the three-year study period (2001-2003). This eighth and final report from the committee examines the hypothesis that vaccines, specifically the MMR vaccine and thimerosal-containing vaccines (TCVs), cause autism. In its first two reports that were published in 2001, the committee examined the hypothesized causal association between the MMR vaccine and autism and TCVs and neurodevelopmental disorders (NDDs), respectively. The IAVG asked the committee to revisit the hypothesized causal association between vaccines and autism in its final report in order to update its conclusions and recommendations based on the significant number of studies that have been undertaken in the last three years.

For each topic, the Immunization Safety Review Committee reviews relevant literature and submissions by interested parties, holds an open scientific meeting, and directly follows the open meeting with a one- to two-day closed meeting to formulate its conclusions and recommendations. The committee’s

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