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加拿大的疫苗警戒:它是否已足够健全?

Vaccine vigilance in Canada: Is it as robust as it could be?

作者信息

Duclos P

机构信息

Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland.

出版信息

Can Commun Dis Rep. 2014 Dec 4;40(Suppl 3):2-6. doi: 10.14745/ccdr.v40is3a01.

Abstract

Canada has been known to have one of the better vaccine safety surveillance capacities in the world, but in the early 2000s, it was noted there was still room for improvement. How has Canada done over the last decade and is there more to be done? Canada has done well. First, there has been significant progress made by the Vaccine Vigilance Working Group to enhance the passive vaccine safety monitoring system and address potential issues arising from the review of surveillance data and cases or clusters of concern. Second, there has been an increased investigative capacity for clusters of adverse events and other vaccine safety issues, including an assessment and referral system for individuals with adverse events following immunizations (AEFIs). Third, the use of the Brighton Collaboration definitions and other international standards has facilitated international collaboration and represents the best standard of practice. Despite all these improvements, however, there is more that could be done. The sensitivity of Canada's passive surveillance system still varies from one province and territory to another. The timeliness of the data exchange flow could improve. The AEFI Signal Response Protocol, which identifies the processes and required actions for timely management of any newly detected or emerging vaccine safety signals, is a critical piece of a robust vaccine safety system but it is still in the making. It is commendable that Canada has decided to expand its focus on evaluation research from influenza vaccines to vaccine-preventable diseases more broadly, with the establishment of the Canadian Immunization Research Network (CIRN). CIRN's newly developed Provincial Collaborative Network and the move toward record linkages is excellent. These new investments are welcome in light of the rich vaccine development pipeline, the increased pool of available vaccines, and the growing set of technologies for vaccines production, delivery, and safety monitoring. What would round this all out would be a stronger capacity to monitor the implementation of vaccination programs and vaccine coverage, and better documentation of the reduction of the disease burden attributable to vaccination programs. Canada's investment in vaccines for the health of all deserves no less.

摘要

加拿大一直以来都拥有世界上较为完善的疫苗安全监测能力之一,但在21世纪初,人们注意到仍有改进的空间。在过去十年里加拿大做得如何?还有更多工作要做吗?加拿大做得很好。首先,疫苗警戒工作组在加强被动疫苗安全监测系统以及解决因审查监测数据和关注的病例或病例群而产生的潜在问题方面取得了重大进展。其次,对不良事件群集和其他疫苗安全问题的调查能力有所提高,包括针对免疫后出现不良事件(AEFI)的个人的评估和转诊系统。第三,采用布莱顿协作组织的定义和其他国际标准促进了国际合作,并代表了最佳实践标准。然而,尽管有这些改进,仍有更多工作可做。加拿大被动监测系统的敏感性在各省和地区之间仍存在差异。数据交换流程的及时性有待提高。AEFI信号响应协议确定了及时管理任何新发现或新出现的疫苗安全信号的流程和所需行动,是强大的疫苗安全系统的关键组成部分,但仍在制定中。值得称赞的是,加拿大决定通过建立加拿大免疫研究网络(CIRN),将其对评估研究的关注范围从流感疫苗更广泛地扩大到疫苗可预防疾病。CIRN新开发的省级协作网络以及向记录链接的转变非常出色。鉴于丰富的疫苗研发产品线、可用疫苗储备的增加以及疫苗生产、交付和安全监测技术的不断增多,这些新投资是受欢迎的。完善这一切还需要更强的能力来监测疫苗接种计划的实施情况和疫苗接种覆盖率,以及更好地记录疫苗接种计划所减轻的疾病负担。加拿大为所有人的健康在疫苗方面的投入当之无愧。

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本文引用的文献

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Canada's Vaccine Vigilance Working Group.加拿大疫苗警戒工作组
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