带状疱疹疫苗(欣格来福)上市后安全性监测-美国,2017 年 10 月-2018 年 6 月。
Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) - United States, October 2017-June 2018.
出版信息
MMWR Morb Mortal Wkly Rep. 2019 Feb 1;68(4):91-94. doi: 10.15585/mmwr.mm6804a4.
Recombinant zoster vaccine (RZV; Shingrix), an adjuvanted glycoprotein vaccine, was licensed by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices for adults aged ≥50 years in October 2017 (1). The previously licensed live-attenuated zoster vaccine (ZVL; Zostavax) is recommended for adults aged ≥60 years. RZV is administered intramuscularly as a 2-dose series, with an interval of 2-6 months between doses. In prelicensure clinical trials, 85% of 6,773 vaccinated study participants reported local or systemic reactions after receiving RZV, with approximately 17% experiencing a grade 3 reaction (erythema or induration >3.5 inches or systemic symptoms that interfere with normal activity). However, rates of serious adverse events (i.e., hospitalization, prolongation of existing hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death) were similar in the RZV and placebo groups (2). After licensure, CDC and FDA began safety monitoring of RZV in the Vaccine Adverse Event Reporting System (VAERS) (3). During the first 8 months of use, when approximately 3.2 million RZV doses were distributed (GlaxoSmithKline, personal communication, 2018), VAERS received a total of 4,381 reports of adverse events, 130 (3.0%) of which were classified as serious. Commonly reported signs and symptoms included pyrexia (fever) (1,034; 23.6%), injection site pain (985; 22.5%), and injection site erythema (880; 20.1%). No unexpected patterns were detected in reports of adverse events or serious adverse events. Findings from early monitoring of RZV are consistent with the safety profile observed in prelicensure clinical trials.
重组带状疱疹疫苗(RZV;欣安立适)是一种佐剂糖蛋白疫苗,于 2017 年 10 月获得美国食品和药物管理局(FDA)批准,并被免疫实践咨询委员会推荐用于≥50 岁的成年人(1)。之前批准的减毒活带状疱疹疫苗(ZVL;带状疱疹疫苗)推荐用于≥60 岁的成年人。RZV 肌肉注射,采用 2 剂系列,两剂之间间隔 2-6 个月。在上市前临床试验中,6773 名接种研究参与者中有 85%在接种 RZV 后报告了局部或全身反应,约 17%发生了 3 级反应(红斑或硬结>3.5 英寸或全身性症状干扰正常活动)。然而,RZV 组和安慰剂组的严重不良事件(即住院、现有住院时间延长、危及生命的疾病、永久性残疾、先天异常或出生缺陷或死亡)发生率相似(2)。上市后,疾病预防控制中心和 FDA 开始在疫苗不良事件报告系统(VAERS)中监测 RZV 的安全性(3)。在使用的前 8 个月,当大约 320 万剂 RZV 分发时(葛兰素史克公司,个人交流,2018 年),VAERS 共收到了 4381 份不良事件报告,其中 130 份(3.0%)被归类为严重。常见报告的体征和症状包括发热(发烧)(1034 例;23.6%)、注射部位疼痛(985 例;22.5%)和注射部位红斑(880 例;20.1%)。在不良事件或严重不良事件报告中未发现意外模式。RZV 的早期监测结果与上市前临床试验中观察到的安全性概况一致。