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疫苗安全性的上市后评估:现状与未来方向。由国际生物标准化联盟(IABS)于2011年4月27日至28日在西班牙巴塞罗那组织的研讨会。

Post-licensure evaluation of vaccine safety: current status and future directions. Symposium organised by the International Alliance for Biological Standardization (IABS) in Barcelona, Spain, 27-28 April 2011.

作者信息

Black Steven, Egan William, Lambert Paul-Henri

机构信息

University of Cincinnati, 3333 Burnet Av, Cincinnati, OH 45229, USA.

出版信息

Biologicals. 2012 Sep;40(5):382-3. doi: 10.1016/j.biologicals.2011.09.001. Epub 2011 Oct 8.

DOI:10.1016/j.biologicals.2011.09.001
PMID:21982850
Abstract

Adverse events following immunization, while rare, unfortunately do occur. And when they do, the public's faith in vaccines waves. It's a known fact, for example, that vaccine safety concerns are among the most important factors contributing to parents refusing vaccination for their children. How best, then, to tackle these concerns and increase public confidence in the vaccine safety system? In an effort to contribute to identifying the right mechanisms, the International Alliance for Biological Standardization organized an international symposium on "Post-Licensure Evaluation of Vaccine Safety" in Barcelona in early Spring. Delegates from 24 countries took a close look at the current status of this challenging problem and identified several practical measures which could help address the situation. They suggested an integrated vaccine safety program to be in place in all countries and standardized so that information and data can be exchanged on a routine basis. Another proposal was to put in place simple measures such as the use of bar codes on vaccine vials.

摘要

免疫接种后的不良事件虽罕见,但不幸的是确实会发生。而一旦发生,公众对疫苗的信心就会动摇。例如,众所周知,疫苗安全问题是导致父母拒绝为孩子接种疫苗的最重要因素之一。那么,如何最好地解决这些担忧并增强公众对疫苗安全体系的信心呢?为努力确定正确的机制,国际生物标准化联盟于早春在巴塞罗那组织了一次关于“疫苗安全上市后评估”的国际研讨会。来自24个国家的代表仔细研究了这一具有挑战性问题的现状,并确定了一些有助于解决该情况的切实可行措施。他们建议在所有国家建立一个综合疫苗安全计划并使其标准化,以便能够定期交换信息和数据。另一项提议是采取一些简单措施,如在疫苗瓶上使用条形码。

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