GSK, Avenue Fleming 20, 1300, Wavre, Belgium.
UCB Pharma, 1420, Braine-l'Alleud, Belgium.
Drug Saf. 2020 Dec;43(12):1223-1234. doi: 10.1007/s40264-020-00989-2.
A diligent, systematic, regular review of aggregate safety data is essential, particularly early after vaccine introduction, as this is when safety signals not identified during clinical development may emerge. In October 2017, the US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommended the adjuvanted recombinant zoster vaccine (RZV; Shingrix, GSK) as the preferred vaccine for preventing herpes zoster (HZ) and related complications in immunocompetent adults aged ≥ 50 years. Subsequently, GSK experienced an unprecedented high demand for RZV. In this methodology paper, we summarize the enhanced measures undertaken to assess RZV safety during its early post-marketing experience in the USA, Canada and Germany. In addition to the routine signal-detection methods already in place for all vaccines, GSK established tailored and enhanced safety monitoring for RZV based on aggregate data of spontaneous reports and manufacturing data. Proactive, near real-time detection and evaluation of signals was a key objective. A dedicated in-house signal-detection tool customized for RZV was employed on a weekly (rather than the routine monthly) basis, allowing for a centralized, more frequent review of data on a single web-based platform. We also identified the background incidence rates of preselected medical events of interest in the first countries to introduce RZV (USA, Canada and Germany) to perform observed-to-expected analyses. This approach may offer a solution to the challenges associated with the assessment and monitoring of vaccine safety in an efficient and timely manner in the context of high vaccine uptake.
进行勤奋、系统、定期的汇总安全性数据审查至关重要，尤其是在疫苗引入后早期，因为此时可能会出现临床开发期间未识别的安全性信号。2017 年 10 月，美国疾病预防控制中心免疫实践咨询委员会建议使用佐剂重组带状疱疹疫苗（RZV；Shingrix，葛兰素史克）作为预防免疫功能正常的 50 岁及以上成人带状疱疹（HZ）和相关并发症的首选疫苗。此后，葛兰素史克对 RZV 的需求空前高涨。在本方法学论文中，我们总结了在美国、加拿大和德国，在 RZV 上市后早期经验中为评估其安全性而采取的强化措施。除了所有疫苗已经实施的常规信号检测方法外，葛兰素史克还根据自发报告和生产数据的汇总数据，为 RZV 制定了专门的强化安全性监测措施。主动、近乎实时地检测和评估信号是一个关键目标。专门为 RZV 定制的内部信号检测工具每周（而不是常规每月）使用一次，允许在单个基于网络的平台上集中、更频繁地审查数据。我们还确定了在首批引入 RZV 的国家（美国、加拿大和德国）中预先选择的医学相关事件的背景发生率，以进行观察到的与预期的分析。这种方法可能为在高疫苗接种率背景下，以有效和及时的方式评估和监测疫苗安全性提供一种解决方案。
