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22 IMMUNIZATION SAFETY RE VIE W year of discussions with IOM to develop the Immunization Safety Review proj- ect to address vaccine safety issues both existing and emerging. THE CHARGE TO THE COMMITTEE The Immunization Safety Review Committee is responsible for examining a broad variety of vaccine safety concerns. Committee members have expertise in pediatrics, neurology, immunology, internal medicine, infectious diseases, ge- netics, epidemiology, biostatistics, risk perception and communication, decision analysis, public health, nursing, and ethics. While all the committee members share the view that vaccination is beneficial, none of them has a vested interest in the vaccine safety issues that will come before the group. Additional discus- sion 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 vaccine safety hypotheses each year during the three-year study period (2001-2003~. The Interagency Vaccine Group made up of officials from the National Vaccine Program Of- fice at DHHS, 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 Department of Defense, the FDA, the National Vaccine Injury Compensation Program at HRSA, the Health Care Financing Administra- tion, and the Agency for International Development selects the hypotheses to be examined by the committee. For each of these, the committee reviews rele- vant literature and submissions by interested parties, and it holds an open scien- tific meeting followed directly by 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 has been asked to assess both the scientific plausibility of the issue and its significance in a broader so- cietal context. The plausibility assessment has two components: an examination of any pathogenic mechanisms relevant to the hypothesis (also known as bio- logic plausibility), and an examination of the evidence regarding a possible causal relationship between the vaccine and the adverse event. The significance assessment addresses such considerations as the nature of the health risks asso- ciated with the vaccine-preventable disease and with the adverse event in ques- tion. Other considerations may include the perceived intensity of public or pro- fessional concern, or the feasibility of additional research to help resolve scientific uncertainty regarding causal associations. The findings of the plausibility and significance assessments provide the basis for the committee's recommendations on public health response, which includes immunization policy review, current and future research, and effective communi- cation strategies for the specific immunization safety questions. Although the committee has been asked to make recommendations related to immunization
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