Immunization Safety Review Thimerosal-Containing Vaccines and Neurodevelopmental Disorders (2001) / Chapter Skim
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Significance Assessment
Significance Assessment
Pages 66-74
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From page 66... ...
SIGNIFICANCE ASSESSMENT In contrast to the majority of previous IOM vaccine safety studies, which limited conclusions to causality assessments and recommendations for future research, the Immunization Safety Review Committee has been asked to recommend a public health response to immunization safety concerns. Such a response potentially encompasses a broad range of activities, including policy reviews, new research directions, and changes in communication to the public and to health care providers about issues of vaccine safety.
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From page 67... ...
Blaxill, 2001 3. Axton, 1972; Cinca et al., 1980; Fagan et al., 1977; Hay, 1963; Jalili and Abbasi, 1961 "Island Studies"7 Indirect Published Indirect Published; unpublished Indirect Published Published Published Indirect Published; unpublished Indirect Published; unpublished Direct Unpublished Evidence of this type N/A could be used to determine nature of causal relationship Unpublished Evidence of this N/A type could support causality Evidence of this Supports type could support causality Evidence of this type Supports could inform causality assessments Evidence of this type Supports could inform causality assessments Hypothesis genera- Supports lion only Hypothesis genera- Supports lion only Hypothesis genera- Supports lion only None Supports 4.
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From page 68... ...
In the present case, the hypothesis that exposure to thimerosal-containing vaccines may be associated with neurodevelopmental disorders remains of public health significance, even though thimerosal has been removed from all vaccines on the recommended childhood immunization schedule that are given to children six years of age or younger. First, neurodevelopmental disorders impose substantial burdens on the affected individuals, their families, and society, and because it is important to understand whether or not past vaccine use has increased the risks of such disorders.
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From page 69... ...
Children with speech and language delay often experience additional problems, including poor school performance, psychological and behavioral disturbances, and, later, speech and language problems (Whitehurst and Herschel, 1994~. Continued Exposure to Thimerosal In the United States, currently manufactured or marketed vaccines on the recommended childhood i~,ni~ation schedule and given to children six years of age or younger contain no ~imerosal, or only Face amounts (<0.5 fig Hg per dose)
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From page 70... ...
Nevertheless, the NHANES survey indicates that 10% of women have mercury levels within one-tenth of the potentially hazardous levels estimated in the NRC toxicological review of methylmercury, indicating a potential benefit for some women from efforts to reduce mercury exposure (CDC, 2001 d, NRC, 2000~. Use of Thimerosal-Containing Vaccines in Other Countries In contrast to the rapid removal of thimerosal from vaccines in the United States, many other countries have taken a less urgent approach to removing thimerosal from vaccines.
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From page 71... ...
Removing thimerosal from multidose vials is not a viable option given the lack of alternative preservatives, thus, removal of thimerosal could increase the risk of bacterial contamination which could lead to toxic shock syndrome or other illnesses. In addition, switching from multi-dose to single-dose vials imposes practical constraints.
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From page 72... ...
. To reduce exposure to thimerosal in the smallest infants, the joint statement also recommended postponing the first dose of hepatitis B vaccine from birth until two to six months of age for infants born to low-risk mothers who were hepatitis B-surface antigen negative.
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From page 73... ...
The experience may offer lessons for improving future vaccine safety policymaking, however. Trust in the Safety of Vaccines Concerns related to the potential adverse effects of thimerosal-containing vaccines and continued use of thimerosal in some vaccines have the potential to erode public trust.
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From page 74... ...
Conclusion The committee sees significant reasons for continued public health attention to concerns about thimerosal exposure and neurodevelopmental disorders. The committee considered the burden of the potential adverse neurodevelopmental outcomes and of vaccine-preventable disorders, and it considered the extent of continued use of thimerosal-containing products.
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