Merck & Co., Inc., Kenilworth, NJ, USA.
Merck & Co., Inc., Kenilworth, NJ, USA.
Vaccine. 2017 Dec 19;35(52):7231-7239. doi: 10.1016/j.vaccine.2017.11.013. Epub 2017 Nov 22.
Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed.
All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed.
A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (<1%) with 38% occurring in immunocompromised individuals. All reports of disseminated HZ confirmed by PCR as VZV Oka/Merck vaccine-strain were in individuals with immunosuppressive conditions and/or therapy at the time of vaccination.
The safety profile of ZVL, following 10 years of post-marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies.
带状疱疹疫苗（ZVL）是一种单价减毒活疫苗，适用于 50 岁及以上人群，用于预防带状疱疹（HZ）。临床试验和上市后研究的安全性数据提供了保证，表明 ZVL 通常是安全且耐受良好的。本综述的目的是提供上市后 10 年和 3400 多万剂疫苗分发后的全球安全性信息。
对 2006 年 5 月 2 日至 2016 年 5 月 1 日期间，全球医疗保健专业人员在接种 ZVL 后向 MSD 全球不良事件安全数据库报告的所有上市后不良体验（AE）报告进行了分析。
共报告了 23556 例 AE 报告，其中 93%为非严重 AE。中位发病时间为 2 天的局部注射部位反应（ISR）是最常见的 AE，其次是 HZ。大多数 HZ 报告发生在接种疫苗后 2 周内，根据发病时间、HZ 的发病机制和临床试验数据，被认为是由野生型水痘-带状疱疹病毒（VZV）引起的。在接种疫苗后 8 个月的免疫功能正常个体和 4 例免疫功能低下个体中，通过 PCR 分析证实为 VZV Oka/Merck 疫苗株的 HZ。罕见报告（<1%）播散性 HZ，其中 38%发生在免疫功能低下个体中。所有通过 PCR 证实为 VZV Oka/Merck 疫苗株的播散性 HZ 报告均发生在接种疫苗时存在免疫抑制状况和/或治疗的个体中。
上市后 10 年使用 ZVL 的安全性与临床试验和上市后研究观察到的一致，是有利的。
