Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, the Netherlands.
Drug Saf. 2010 Dec 1;33(12):1097-108. doi: 10.2165/11539270-000000000-00000.
In November 2009, a vaccination campaign against Influenza A (H1N1) was started in the Netherlands. The accelerated registration procedure of the vaccines used in this campaign and the use of these vaccines on a large scale indicated a need for real-time safety monitoring.
To describe the processing, analysing and performing of signal detection by the Netherlands Pharmacovigilance Centre (Lareb) on reports of adverse events following immunization (AEFI) with respect to the two pandemic influenza vaccines, Focetria® and Pandemrix®, used in the Netherlands. The secondary aim is to provide a summary of the results of the safety monitoring of both vaccines.
Description of the process of collecting information and analysis of the safety monitoring of the pandemic vaccines during the vaccination campaign against H1N1 in the Netherlands. An observational study on adverse events following immunization (AEFIs) associated with vaccines used in this campaign was conducted.
The use of a dedicated web form with predefined AEFIs enabled an efficient way of processing and analysing the reports, resulting in a close to real-time monitoring of the safety of the vaccines. From 1 November 2009 until 1 March 2010, 7534 reports concerning one or more AEFIs possibly related to the administration of both vaccines were received. 2788 of the reports related to Focetria® and 4746 of the reports related to Pandemrix®. The total time between receiving the reports and completion was longer for the serious reports (average 2.8 days) compared with the non-serious reports (average 0.8 days). The profile of the reported adverse events is comparable with the information provided in the Summary of Product Characteristics (SPC). Differences in reported AEFIs between both vaccines may be caused by bias and confounding due to the different populations for which these vaccines have been used. No signals of possible batch-related problems were detected for either vaccine.
The method applied allowed for real-time monitoring for AEFIs during the mass vaccination campaign. The use of web-based forms, preferably with information on venue and used batch numbers, enabled an efficient monitoring of possible batch-related problems. No major safety issues occurred with respect to the type of reported AEFIs, or with the batches of either vaccine.
2009 年 11 月，荷兰启动了甲型 H1N1 流感疫苗接种运动。在这次接种运动中，疫苗的加速注册程序以及大规模使用这些疫苗表明有必要进行实时安全性监测。
描述荷兰药品监测中心（Lareb）在针对两种用于荷兰大流行流感疫苗（Focetria®和 Pandemrix®）的接种后不良反应（AEFI）报告中进行信号检测的处理、分析和执行情况。次要目的是总结两种疫苗的安全性监测结果。
描述在荷兰针对 H1N1 的疫苗接种运动期间收集信息和分析大流行疫苗安全性监测的过程。对该运动中使用的疫苗接种后不良反应（AEFIs）进行了观察性研究。
使用带有预定义 AEFI 的专用网络表格，能够高效地处理和分析报告，从而实现了对疫苗安全性的近乎实时监测。从 2009 年 11 月 1 日至 2010 年 3 月 1 日，共收到 7534 份关于一种或多种可能与两种疫苗相关的 AEFI 的报告。其中 2788 份报告与 Focetria®有关，4746 份报告与 Pandemrix®有关。严重报告的总报告时间（平均 2.8 天）明显长于非严重报告（平均 0.8 天）。报告的不良事件的特征与产品特性摘要（SPC）中提供的信息相似。两种疫苗之间报告的 AEFI 差异可能是由于使用的人群不同而导致的偏倚和混杂。未发现任何与批次相关问题的信号。
所应用的方法允许在大规模疫苗接种运动期间实时监测 AEFI。使用基于网络的表格，最好带有地点和使用批次号的信息，能够有效地监测可能与批次相关的问题。就报告的 AEFI 类型或任何一种疫苗的批次而言，均未出现重大安全问题。
