Adverse events following pandemic influenza vaccine Pandemrix® reported in the French military forces-2009-2010
Adverse events following pandemic influenza vaccine Pandemrix® reported in the French military forces-2009-2010
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DOI：
10.1016/j.vaccine.2011.01.056
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发表时间：
2011-03-21
期刊：
影响因子：
5.5
通讯作者：
Migliani, Rene
中科院分区：
文献类型：
--
作者：
Mayet, Aurelie;Ligier, Caroline;Migliani, Rene
背景：面对2009年甲型H1N1流感大流行，2009年10月，法国军事卫生服务（SSA）在军队中发起了一场大规模的Pandemrix (R)疫苗接种运动。本研究的目的是描述该运动期间报告的疫苗不良事件（VAE）。方法：2009年10月至2010年4月期间，SSA流行病学网络对所有军队的VAE和接种疫苗人数进行了调查。对于每个病例，填写一份通知表格，提供患者和临床信息。我们考虑了三种类型的VAE：不严重、严重和意外。结果：每10万次疫苗接种报告VAE为315.4例。疫苗接种率和VAE发病率高峰与12月初流感流行高峰重合。注射剂量为49,138剂，相当于军事人员疫苗接种率为14.5%，报告VAE 155例，其中严重VAE 5例（格林-巴利综合征1例，乏力2例，惊厥发作1例）。大多数VAE不严重（97.1%）。其中局部快速退行性感觉异常6例。讨论：军用VAE监视系统是法国唯一的良性VAE观测站。大流行疫苗接种后的报告率远高于季节性疫苗接种后的报告率，这可能是刺激报告的反映。本报告提供了在大规模紧急疫苗接种计划期间军事人员VAE的有用描述，表明大流行性疫苗的耐受性似乎是可以接受的。(C) 2011 Elsevier Ltd.版权所有。
Background: In the face of the A(H1N1) 2009 influenza pandemic, in October 2009 the French military health service (SSA) initiated a large vaccination campaign with Pandemrix (R) vaccine in the military forces. The aim of this study was to describe vaccine adverse events (VAE) reported during this campaign.Methods: VAE and the number of people vaccinated were surveyed by the SSA Epidemiological network across all military forces during the campaign, from October 2009 to April 2010. For each case, a notification form was completed, providing patient and clinical information. Three types of VAE were considered: non-serious, serious and unexpected.Results: There were 315.4 reported VAE per 100,000 vaccinations. Vaccination and VAE incidence rate peaks coincided with influenza epidemic peak in early December. The number of injected doses was 49,138, corresponding to a 14.5% vaccination coverage among military personnel, and 155 VAE were reported, including 5 serious VAE (1 Guillain-Barre syndrome, 2 malaises and 1 convulsive episode). Most VAE were non-serious (97.1%). Among these, 6 cases of local, rapidly regressive paresthesia were observed.Discussion: The military VAE surveillance system constitutes the only observatory on benign VAE in France. The reporting rate was much higher after the pandemic vaccine than after the seasonal vaccine, which may be a reflection of stimulated reporting. This report provides a useful description of VAE among military personnel during a mass emergency vaccination program, showing that the tolerance of the pandemic vaccine appeared acceptable. (C) 2011 Elsevier Ltd. All rights reserved.