An assessment of thimerosal use in childhood vaccines
An assessment of thimerosal use in childhood vaccines
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DOI：
10.1542/peds.107.5.1147
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发表时间：
2001-05-01
期刊：
影响因子：
8
通讯作者：
Pratt, RD
中科院分区：
文献类型：
--
作者：
Ball, LK;Ball, R;Pratt, RD
背景1999年7月7日，美国儿科学会和美国公共卫生署发表联合声明，呼吁从疫苗中去除含汞防腐剂硫柳汞。这一行动部分是由食品和药物管理局的风险评估所推动的。风险评估包括危害识别、剂量-反应评估、接触评估和风险定性。对文献进行了审查，以确定硫柳汞、乙基汞（硫柳汞的代谢物）和甲基汞（一种类似的有机汞化合物）的已知毒性，并确定发生毒性的剂量。根据美国儿童免疫接种计划，计算了6个月大和2岁儿童的疫苗汞最大潜在暴露量，并与环境保护署（EPA）、有毒物质和疾病登记署、食品和药物管理局以及世界卫生组织制定的汞暴露限值进行了比较。硫柳汞暴露引起的迟发型超敏反应已得到广泛认可。意外高剂量接触硫柳汞的已确定急性毒性包括神经毒性和肾毒性。关于低剂量接触乙基汞的毒性数据有限，但毒性可能与甲基汞相似。慢性低剂量甲基汞暴露可能导致轻微的神经系统异常。根据免疫接种计划、疫苗配方和婴儿体重，婴儿在出生后前6个月内从硫柳汞中累积暴露于汞可能超过EPA指南。我们的审查显示，除了局部超敏反应外，没有证据表明疫苗中的硫柳汞剂量会造成伤害。然而，一些婴儿在出生后的前6个月内可能暴露于超过EPA建议的汞累积水平。通过使用不含硫柳汞作为防腐剂的产品，可以减少或消除婴儿接触疫苗中的汞。
Background. On July 7, 1999, the American Academy of Pediatrics and the US Public Health Service issued a joint statement calling for removal of thimerosal, a mercury-containing preservative, from vaccines. This action was prompted in part by a risk assessment from the Food and Drug Administration that is presented here.Methods. The risk assessment consisted of hazard identification, dose-response assessment, exposure assessment, and risk characterization. The literature was reviewed to identify known toxicity of thimerosal, ethylmercury (a metabolite of thimerosal) and methylmercury (a similar organic mercury compound) and to determine the doses at which toxicity occurs. Maximal potential exposure to mercury from vaccines was calculated for children at 6 months old and 2 years, under the US childhood immunization schedule, and compared with the limits for mercury exposure developed by the Environmental Protection Agency (EPA), the Agency for Toxic Substance and Disease Registry, the Food and Drug Administration, and the World Health Organization.Results. Delayed-type hypersensitivity reactions from thimerosal exposure are well-recognized. Identified acute toxicity from inadvertent high-dose exposure to thimerosal includes neurotoxicity and nephrotoxicity. Limited data on toxicity from low-dose exposures to ethylmercury are available, but toxicity may be similar to that of methylmercury. Chronic, low-dose methylmercury exposure may cause subtle neurologic abnormalities. Depending on the immunization schedule, vaccine formulation, and infant weight, cumulative exposure of infants to mercury from thimerosal during the first 6 months of life may exceed EPA guidelines.Conclusion. Our review revealed no evidence of harm caused by doses of thimerosal in vaccines, except for local hypersensitivity reactions. However, some infants may be exposed to cumulative levels of mercury during the first 6 months of life that exceed EPA recommendations. Exposure of infants to mercury in vaccines can be reduced or eliminated by using products formulated without thimerosal as a preservative.