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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality
Controlled Clinical Trials
There is biologic plausibility for a causal relation between measles vaccine and GBS. GBS has been shown to follow natural measles virus infection. As described in Chapter 3, several vaccines and viruses are suspected of playing a role in GBS. Reports in the literature describing a possible relation between GBS and measles vaccine are case reports, case series, and uncontrolled observational studies. These include at most a total of six cases of GBS reported in the published literature and seven cases from VAERS. These cases were temporally related to vaccination; however, lack of clinical details and other antecedent events preclude a determination of a causal relation.
The evidence is inadequate to accept or reject a causal relation between measles vaccine and GBS.
INSULIN-DEPENDENT DIABETES MELLITUS
Diabetes mellitus is a genetically determined disease manifested by abnormal metabolism of carbohydrate, protein, and fat (Fajans, 1989; Kaplan, 1990). Type I or insulin-dependent diabetes mellitus (IDDM) is associated with an insufficiency of insulin secretion by pancreatic beta cells and is characterized by an absolute need for injected insulin to sustain life. In most cases the onset of IDDM is in childhood, but it may occur at any age. Almost all diabetes in children is insulin-dependent. Approximately 10 to 15 percent of diabetics in industrialized countries have IDDM. The annual incidence of IDDM in the United States is about 12 to 14 new cases per 100,000 children ages 0 to 16 years. By age 20, approximately 0.3 percent of individuals will have developed IDDM.
History of Suspected Association
Although the pathogenesis of IDDM is not completely understood, most investigators feel that both environmental and genetic factors are involved, and there are compelling data suggesting that viruses may be one of the