Thiomersal in vaccines: a regulatory perspective WHO Consultation, Geneva, 15-16 April 2002.
Thiomersal in vaccines: a regulatory perspective WHO Consultation, Geneva, 15-16 April 2002.
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DOI：
10.1016/j.vaccine.2003.11.051
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发表时间：
2004-05-07
期刊：
影响因子：
5.5
通讯作者：
Dobbelaer, R
中科院分区：
文献类型：
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作者：
Knezevic, I;Griffiths, E;Dobbelaer, R
在过去十年中，人们对在疫苗中使用有机汞防腐剂乙基汞（通常称为硫柳汞）提出了安全问题。尽管这些安全性问题是理论上的，但风险意识仍然存在，并导致一些国家采取举措，在所有单剂量和多剂量疫苗中消除、减少或取代硫柳汞。由此产生的问题是，是否有令人信服的科学或医学证据可以从疫苗中去除硫柳汞[1-6]。此外，需要哪些证据来确保去除硫柳汞的疫苗与已获得许可的产品一样安全有效。因此，消除、减少或替代疫苗中硫柳汞的战略不仅提出了与乙基汞的毒性和疫苗中防腐剂的效力有关的问题，而且还提出了硫柳汞对疫苗本身的质量、安全性和效力的影响问题。硫柳汞在疫苗中不仅用作防腐剂，有时还用作生产过程中的灭活剂。世卫组织关于硫柳汞使用的政策[7]是明确的。本组织继续建议在全球免疫计划中使用含有硫柳汞的疫苗，因为使用此类产品的益处远远超过任何理论上的毒性风险[8，9]。然而，由于一些国家正在考虑从单剂量和
Over the past decade, safety concerns have been raised over the use of the organo-mercurial preservative ethyl mercury, often called thiomersal, in vaccines. Although these safety concerns are theoretical, the perception of risk remains and has led to initiatives in some countries to eliminate, reduce or replace thiomersal in all mono-dose and multi-dose vaccine presentations. The question arises as to whether there is compelling scientific or medical evidence for removing thiomersal from vaccines [1–6]. Also, what evidence is needed to ensure that vaccines from which thiomersal has been removed are as safe and efficacious as those products already licensed. The strategy for the elimination, reduction or replacement of thiomersal in vaccines therefore raises issues relating not only to the toxicity of ethyl mercury and the efficacy of preservatives in vaccines, but also to the effects of thiomersal on the quality, safety and efficacy of the vaccines themselves. Thiomersal is used in vaccines not only as a preservative but also sometimes as an inactivating agent during production. WHO policy [7] on the use of thiomersal is clear. The Organization continues to recommend the use of vaccines containing thiomersal for global immunization programs since the benefits of using such products far outweigh any theoretical risk of toxicity [8, 9]. However, since some countries were considering removing thiomersal from both mono-dose and