Harris T, Wong K, Nair J, Fediurek J, Deeks S L
Public Health Ontario, Toronto, ON.
Dalla Lana School of Public Health, University of Toronto, Toronto, ON.
Can Commun Dis Rep. 2016 Sep 1;42(9):181-186. doi: 10.14745/ccdr.v42i09a04.
Influenza vaccine is recommended to prevent influenza-related morbidity and mortality. Post-marketing surveillance of adverse events following influenza vaccine is essential to monitor vaccine safety, inform immunization program planning and evaluation, and build confidence in immunization.
To summarize adverse events following immunization (AEFIs) reported after receipt of influenza vaccines administered within the Universal Influenza Immunization Program in Ontario.
AEFIs following administration of influenza vaccines between September 1, 2012 and August 31, 2015 were extracted from the Integrated Public Health Information System (iPHIS) on September 1, 2015. Events were grouped by provincial surveillance definitions. Reporting rates were calculated using provincial population estimates or net doses distributed as the denominator. The standard World Health Organization definition of serious AEFIs was used.
There were 12.1 million doses of influenza vaccine distributed in Ontario and 528 AEFIs reported following influenza vaccines administered over three seasons. The annualized reporting rate was 4.4 per 100,000 doses distributed with a significant decreasing trend over time (<0.05). The median age was 39.6 years (range six months-96 years); children under four years of age had the highest reporting rate (3.5 per 100,000 population). Disproportionate reporting among females was observed (76.5 percent), most notably in those 18 years and older. The most frequently reported events were injection site reactions (36.2 percent of reports). Others included allergic skin reactions (21.1 percent) and rashes (17.3 percent). Serious AEFIs were rare with a reporting rate of 1.6 per million doses distributed.
This assessment found a low rate of reported adverse events following influenza vaccines administered in Ontario. Most reported events were mild and resolved completely. The findings were consistent with the very good safety profile of influenza vaccines.
推荐接种流感疫苗以预防与流感相关的发病和死亡。对流感疫苗接种后不良事件进行上市后监测对于监测疫苗安全性、为免疫规划的制定和评估提供信息以及增强对免疫接种的信心至关重要。
总结安大略省通用流感免疫规划中接种流感疫苗后报告的免疫接种后不良事件（AEFI）。
2015年9月1日从综合公共卫生信息系统（iPHIS）中提取2012年9月1日至2015年8月31日期间接种流感疫苗后的AEFI。事件按照省级监测定义进行分组。报告率以省级人口估计数或分发的净剂量为分母进行计算。采用世界卫生组织对严重AEFI的标准定义。
安大略省共分发了1210万剂流感疫苗，在三个季节接种流感疫苗后报告了528例AEFI。年化报告率为每10万剂分发量中有4.4例，且随时间呈显著下降趋势（<0.05）。中位年龄为39.6岁（范围为6个月至96岁）；4岁以下儿童的报告率最高（每10万人口中有3.5例）。观察到女性报告比例过高（76.5%），在18岁及以上人群中最为明显。报告最频繁的事件是注射部位反应（占报告的36.2%）。其他包括过敏性皮肤反应（21.1%）和皮疹（17.3%）。严重AEFI很少见，报告率为每百万剂分发量中有1.6例。
该评估发现安大略省接种流感疫苗后报告的不良事件发生率较低。大多数报告的事件为轻度且完全缓解。这些发现与流感疫苗非常良好的安全性特征一致。
