Department of Clinical and Experimental Medicine, University of Surrey, Surrey, UK.
GlaxoSmithKline, Wavre, Belgium.
Adv Ther. 2018 Aug;35(8):1199-1214. doi: 10.1007/s12325-018-0747-4. Epub 2018 Jul 11.
The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced safety surveillance (ESS) of seasonal influenza vaccines including a near real-time evaluation of collected data. The objective was to identify whether the use of passive surveillance or active surveillance provides different results of reported adverse events of interest (AEIs) by specified age strata and AEI type. We report the weekly incidence rates of AEIs within 7 days following seasonal influenza vaccination using passive and active surveillance.
AEIs were collected within 7 days of vaccination from ten general practices predominantly administering inactivated quadrivalent influenza vaccine (IIV4, Fluarix Tetra, GSK). Vaccinees completed an adverse drug reaction (ADR) card. ADR card and medically attended AEIs data were recorded in practice electronic health records. We report the outcome of the first 5 weeks of safety surveillance (September 12, 2016-October 16, 2016); in an exploratory analysis, rates of AEI for IIV4 are compared to those passively reported through a sentinel network.
Practices vaccinated 13.1% (12,864/98,091) of their registered population; 5.6% (95% CI 5.20-6.00) of them reported AEIs, none serious. The most frequent were respiratory 2.60% (95% CI 2.33-2.88), musculoskeletal 1.82% (95% CI 1.59-2.05) and neurological 1.05% (95% CI 0.88-1.23). AEIs were more frequently reported for adults than for children; 5.91% (95% CI 5.49-6.34) compared to 1.49% (95% CI 0.69-2.29); 47.18% of the adults reported AEI using the ADR card, none were returned for subjects < 18 years old. The frequency of AEIs reporting was higher, 6.88% (95% CI 6.35-7.42) vs. 3.30% (95% CI 2.68-3.96, 100/3028, p < 0.000), through ESS than passive surveillance.
The ESS did not reveal any safety signal and we demonstrated the feasibility of conducting ESS following EMA recommendations. The use of a customised ADR card led to a doubling of AEIs reports over passive surveillance in adults.
GlaxoSmithKline Biologicals SA, Wavre, Belgium.
欧洲药品管理局（EMA）要求疫苗制造商对季节性流感疫苗进行强化安全性监测（ESS），包括对收集数据的实时评估。目的是确定被动监测或主动监测是否会对特定年龄组和不良事件（AEI）类型报告的不良事件（AEI）产生不同的结果。我们报告了使用被动和主动监测在接种季节性流感疫苗后 7 天内的 AEI 每周发生率。
在接种疫苗后 7 天内，10 家主要接种灭活四价流感疫苗（IIV4，Fluarix Tetra，GSK）的常规诊所收集 AEI。接种者填写药物不良反应（ADR）卡。ADR 卡和医疗就诊的 AEI 数据记录在诊所的电子健康记录中。我们报告了安全性监测的前 5 周的结果（2016 年 9 月 12 日至 2016 年 10 月 16 日）；在探索性分析中，我们将 IIV4 的 AEI 发生率与通过哨点网络被动报告的发生率进行了比较。
诊所为其登记人口的 13.1%（12864/98091）接种了疫苗；其中 5.6%（95%CI5.20-6.00）报告了 AEI，无严重事件。最常见的是呼吸道 2.60%（95%CI2.33-2.88），肌肉骨骼 1.82%（95%CI1.59-2.05）和神经系统 1.05%（95%CI0.88-1.23）。成人报告的 AEI 比儿童更频繁；5.91%（95%CI5.49-6.34）与 1.49%（95%CI0.69-2.29）相比；47.18%的成年人使用 ADR 卡报告 AEI，对于年龄<18 岁的人没有返回。ESS 报告的 AEI 频率更高，6.88%（95%CI6.35-7.42）与 3.30%（95%CI2.68-3.96，100/3028，p<0.000）相比，这是因为根据 EMA 的建议进行了 ESS。
ESS 未发现任何安全性信号，我们证明了根据 EMA 建议进行 ESS 的可行性。使用定制的 ADR 卡使成年人的 AEI 报告比被动监测增加了一倍。
葛兰素史克生物制品公司，比利时瓦勒。
