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2015年澳大利亚维多利亚州季节性流感疫苗接种后的过敏不良事件。

Allergic adverse events following 2015 seasonal influenza vaccine, Victoria, Australia.

作者信息

Clothier Hazel J, Crawford Nigel, Russell Melissa A, Buttery Jim P

机构信息

SAEFVIC, Murdoch Childrens Research Institute, Victoria, Australia.

School of Population & Global Health, University of Melbourne, Victoria, Australia.

出版信息

Euro Surveill. 2017 May 18;22(20). doi: 10.2807/1560-7917.ES.2017.22.20.30535.

Abstract

Australia was alerted to a possible increase in allergy-related adverse events following immunisation (AEFI) with 2015 seasonal trivalent influenza vaccines (TIV) by the Victorian state vaccine safety service, SAEFVIC. We describe SAEFVIC's initial investigation and upon conclusion of the 2015 influenza vaccination programme, to define the signal event and implications for vaccine programmes. Allergy-related AEFI were defined as anaphylaxis, angioedema, urticaria or generalised allergic reaction. Investigations compared 2015 TIV AEFI reports to previous years as proportions and reporting risk (RR) per 100,000, stratified by influenza vaccine brand. The initial investigation showed an increased proportion of allergy-related AEFI compared with 2014 (25% vs 12%), predominantly in adults, with insufficient clinical severity to alter the programme risk-benefit. While overall TIV AEFI RR in 2015 was similar to previous years (RR: 1.07, 95% confidence interval (CI): 0.88-1.29), we identified a near-doubling RR for allergy-related AEFI in 2015 (RR: 1.78, 95% CI: 1.14-- 2.80) from 2011 to 2014 with no difference by vaccine brand or severity increase identified. This increase in generalised allergy-related AEFI, across all used vaccine brands, supports evidence of variable reactogenicity arising from influenza vaccine strain variations. This investigation underlines the importance of effective seasonal influenza vaccine pharmacovigilance.

摘要

维多利亚州疫苗安全服务机构SAEFVIC提醒澳大利亚,2015年季节性三价流感疫苗(TIV)免疫接种后与过敏相关的不良事件(AEFI)可能增加。我们描述了SAEFVIC的初步调查情况,以及在2015年流感疫苗接种计划结束时,确定信号事件及其对疫苗计划的影响。与过敏相关的AEFI被定义为过敏反应、血管性水肿、荨麻疹或全身性过敏反应。调查将2015年TIV AEFI报告与前几年的数据进行比较,以每10万人的比例和报告风险(RR)来衡量,并按流感疫苗品牌进行分层。初步调查显示,与2014年相比,与过敏相关的AEFI比例有所增加(25%对12%),主要发生在成年人中,临床严重程度不足以改变该计划的风险效益。虽然2015年总体TIV AEFI RR与前几年相似(RR:1.07,95%置信区间(CI):0.88 - 1.29),但我们发现2015年与过敏相关的AEFI的RR相比2011年至2014年几乎翻倍(RR:1.78,95%CI:1.14 - 2.80),且未发现疫苗品牌或严重程度增加方面的差异。所有使用的疫苗品牌中与全身性过敏相关的AEFI增加,支持了流感疫苗毒株变异导致反应原性变化的证据。这项调查强调了有效的季节性流感疫苗药物警戒的重要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9083/5479975/61171967a2e0/eurosurv-22-30535-f1.jpg

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