Immunization Safety Review Vaccinations and Sudden Unexpected Death in Infancy (2003) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-16
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Fatal anaphylaxis in infants is extraordinarily rare. The committee found no basis for a review of current immunization policies, but saw a clear need for continued research on adverse events following vaccination and on the biological basis for sudden unexpected infant deaths.
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In this sixth report in the series, the committee examines the hypothesis that infant vaccination is associated with an increased risk of sudden unexpected death during the first year of life. The committee is charged with assessing both the scientific evidence regarding the hypotheses under review and the significance of the issues for society: · The scientific assessment has two components: an examination of the epidemiologic and clinical evidence regarding a possible causal relationship between exposure to 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.
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The committee does not conclude that the vaccine does not cause the adverse event merely if the evidence is inadequate to support causality. Instead, it concludes that the "evidence is inadequate to accept or reject a causal relationship." Biological Mechanisms Evidence considered in the scientific assessment of biological mechanisms)
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The committee's charge, however, was to examine sudden unexpected infant death, not all-causes of death. SIDS is defined as "the sudden death of an infant under 1 year of age, which remains unexplained after a thorough case investigation, including performance of a complete autopsy, examination of the death scene, and review of the clinical history" (Willinger et al., 1991~.
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Over 35 IBM, including some FAO disorders, can now be identified through analysis of blood or bile specimens using a process of tandem mass spectrometry (Chace and Naylor, 2002~. Such analysis is sometimes conducted as part of a "metabolic autopsy" in cases of sudden unexpected infant death (Wilcox et al., 2002~.
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immunization recommendations do not call for administration of any live-virus vaccines during the first year of life. Sudden Infant Death Syndrome (SIDS)
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The committee concludes that the evidence favors rejection of a causal relationship between exposure to multiple vaccines and SIDS. Sudden Unexpected Death The committee reviewed two published studies that examined the association between exposure to multiple vaccines and all sudden unexpected death in infants.
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For guidance, the committee looked to the various lines of research on SIDS, as reflected in the triple-risk models, and focused on vaccination as a potential source of stressors. Considering both explained and unexplained infant deaths, the committee reviewed the evidence regarding biological mechanisms that might be related to vaccination in terms of three possible pathways: neuroregulatory abnormalities (including homeostatic and autonomic functions)
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Inborn Errors of Metabolism IBM involve deficiencies of specific enzymes or transport proteins, and those disorders which are related to defects in fatty acid oxidation (FAO) have been linked to sudden unexpected infant deaths (e.g., Bennett and Powell, 1994; Mathur et al., 1999; Strauss et al., 1995~.
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Infants are among the most vulnerable members of society, and protecting them from avoidable health risks is a responsibility that parents share with physicians, nurses, others who provide health care, vaccine manufacturers, and officials who shape and implement health policies. Although the death of an infant from any cause is a grave loss to a family, infant deaths that might result from efforts to protect health must be a source of special concern.
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Third, controlled prospective cohort studies to assess possible vaccine-related risks are difficult to conduct because SIDS deaths are increasingly rare and because most children in the United States are vaccinated. RECOMMENDATIONS FOR PUBLIC HEALTH RESPONSE Policy Review The committee does not recommend a policy review of the recommended childhood vaccination schedule by any of the national or federal vaccine advisory bodies on the basis of concerns about sudden unexpected death in · n mIancy.
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Also available is an international standardized protocol for autopsies in cases of sudden unexpected infant death (Krous, 1996~. In the United States, however, requirements for investigation of unexpected infant deaths are officially established by state and local statutes (CDC, 1996~.
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Distinguishing Sudden Infant Death Syndrome from Child Abuse Fatalities (RE0036) Policy Statement.
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1996. Guidelines for Death Scene Investigation of Sudden, Unexplained Infant Deaths: Recommendations of the Interagency Panel on Sudden Infant Death Syndrome.
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2002. Postmortem screening for fatty acid oxidation disorders by analysis of Guthrie cards with tandem mass spectrometry in sudden unexpected death in infancy.
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