result 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 to address vaccine safety issues both existing and emerging.

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 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. Kenneth Shine, President of the IOM.

The committee is charged with examining three immunization safety hypotheses each year during the three-year study period (2001–2003). These hypotheses are selected by the Interagency Vaccine Group, whose members represent several units of the Department of Health and Human Services (DHHS)— the National Vaccine Program Office, the National Immunization Program, and the National Center for Infectious Diseases at the CDC, the National Institute for Allergy and Infectious Diseases at the NIH, the Food and Drug Administration (FDA), the National Vaccine Injury Compensation Program at the Health Resources and Services Administration (HRSA), and the Centers for Medicare and Medicaid Services (CMS, formerly the Health Care Financing Administration)—and the Department of Defense and the Agency for International Development. 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 findings are released to the public in a brief consensus report 60–90 days after its meeting.

For each hypothesis to be examined, the committee assesses both the scientific evidence and the significance of the issue for society.

  • The scientific assessment has two components: an examination of the epidemiological and clinical evidence regarding a possible causal relationship between the vaccine and the adverse event, and an examination of theory and experimental evidence from human or animal studies regarding biological mechanisms that might be relevant to the hypothesis.

  • The significance assessment addresses such considerations as the burden of the health risks associated with the vaccine-preventable disease and with the adverse event. Other considerations may include the perceived intensity of public or professional concern, or the feasibility of additional research to help resolve scientific uncertainty regarding causal associations.

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