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现场记录:与脑膜炎球菌结合疫苗相关的接种差错——美国,2010 年 3 月 1 日至 2015 年 9 月 22 日。

Notes from the Field: Administration Error Involving a Meningococcal Conjugate Vaccine--United States, March 1, 2010-September 22, 2015.

出版信息

MMWR Morb Mortal Wkly Rep. 2016 Feb 19;65(6):161-2. doi: 10.15585/mmwr.mm6506a4.

DOI:10.15585/mmwr.mm6506a4
PMID:26890604
Abstract

Menveo (GlaxoSmithKline, previously Novartis AG) is a conjugate vaccine that was recommended in October 2010 for routine use in adolescents (preferably aged 11 or 12 years, with a booster at 16 years), and among persons aged 2 through 54 years with certain immunosuppressive conditions, to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (1). These recommendations have since been updated (2). Menveo is supplied in two vials that must be combined before administration. The MenA lyophilized (freeze-dried) component must be reconstituted with the MenCYW-135 liquid component (Figure). To administer the vaccine, the liquid component is drawn into a syringe, and used to reconstitute the lyophilized component. The resulting solution is administered by intramuscular injection. Failure to prepare Menveo as directed by the manufacturer's instructions can lead to lack of protection against the intended pathogens (N. meningitidis serogroups A, C, Y, and/or W-135) (3). Recently, an immunization provider administered only the lyophilized component of Menveo, subsequently administered a properly prepared dose of Menveo to the same patient, and asked CDC if this practice was safe. This question prompted CDC to search the Vaccine Adverse Event Reporting System (VAERS) database for reports during March 1, 2010-September 22, 2015, of only one component of Menveo being administered. Additionally, to more broadly identify disproportional reporting of adverse events in general following Menveo immunization compared with other vaccines in VAERS (including errors in vaccine preparation and administration), the Food and Drug Administration performed data mining with empiric Bayesian methods (4).

摘要

曼海欣(葛兰素史克公司,前身为诺华公司)是一种结合疫苗,于 2010 年 10 月被推荐用于青少年(优选年龄为 11 或 12 岁,16 岁时加强一剂),以及 2 至 54 岁具有某些免疫抑制状况的人群中,以预防由脑膜炎奈瑟菌血清群 A、C、Y 和 W-135 引起的侵袭性脑膜炎球菌病(1)。这些建议此后已被更新(2)。曼海欣装在两个小瓶中,使用前必须混合。MenA 冻干(冷冻干燥)成分必须与 MenCYW-135 液体制剂混合(图)。为了接种疫苗,将液体制剂吸入注射器中,并用于重悬冻干成分。得到的溶液通过肌肉内注射给药。如果未按照制造商的说明制备曼海欣,可能会导致对预期病原体(脑膜炎奈瑟菌血清群 A、C、Y 和/或 W-135)缺乏保护(3)。最近,一名免疫接种提供者仅给予了曼海欣的冻干成分,随后向同一患者给予了正确制备的剂量的曼海欣,并询问疾病预防控制中心这种做法是否安全。这个问题促使疾病预防控制中心在 2010 年 3 月 1 日至 2015 年 9 月 22 日期间在疫苗不良事件报告系统(VAERS)数据库中搜索仅给予曼海欣的一个成分的报告。此外,为了更广泛地确定与 VAERS 中其他疫苗相比,接种曼海欣后一般不良事件报告的比例是否失调(包括疫苗准备和管理中的错误),食品和药物管理局使用经验贝叶斯方法进行数据挖掘(4)。

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