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儿童中互换减毒活MAV/06株和OKA株水痘疫苗的安全性。

Safety of Interchanging the Live Attenuated MAV/06 Strain and OKA Strain Varicella Vaccines in Children.

作者信息

Kang Hyun Mi, Kim Gwanglok, Choe Young June

机构信息

Department of Pediatrics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Republic of Korea.

Department of Corporate Development, GC Biopharma Corporation, Yongin 16924, Republic of Korea.

出版信息

Vaccines (Basel). 2023 Aug 31;11(9):1442. doi: 10.3390/vaccines11091442.

Abstract

Two live attenuated varicella vaccine (VZV) strains have been mainly used across the globe: MAV/06 and OKA strains. We aimed to explore the safety of interchanging the two VZV strains for primary and booster immunizations. South Korea's vaccine adverse event reporting system (VAERS) was accessed and searched to find filed reports of all adverse events (AEs) following immunization with the second dose of the varicella vaccine. The electronic medical records were reviewed for all visits to the hospital following the second dose of the varicella vaccine. Of the total 406 study participants, 27.5% (n = 112) were in the MAV/06-MAV/06 group, 30.3% (n = 123) in the MAV/06-OKA, 17.5% (n = 71) in the OKA-MAV/06 group, and 24.6% (n = 100) in the OKA-OKA group. Mean age at immunization with the first dose was 1.10 (standard deviation [SD] ±0.34) years old, and second dose was 4.77 (SD ± 1.13) ( = 0.772 and 0.933, respectively). There were no filed reports of AEs following the second dose in the national VAERS. Hospital visit records showed a total of 10.3% (95% confidence interval [CI], 7.6-13.7) (n = 42) had recorded AEs following the 2nd administered dose; however, only 0.7% (95% CI, 0.2-2.4) (n = 3) were regarded as possibly vaccine related. Two patients in the MAV/06-OKA group were diagnosed with Henoch-Schonlein purpura after the second dose; however, both had also received the MMR vaccine on the same day. No safety signals associated with interchanging the MAV/06 and OKA strain live attenuated varicella vaccines were observed in this patient cohort of healthy children.

摘要

全球主要使用两种减毒活水痘疫苗(VZV)毒株:MAV/06和OKA毒株。我们旨在探讨在初次免疫和加强免疫中互换这两种VZV毒株的安全性。访问并检索了韩国的疫苗不良事件报告系统(VAERS),以查找接种第二剂水痘疫苗后所有不良事件(AE)的存档报告。对第二剂水痘疫苗接种后所有到医院就诊的电子病历进行了审查。在总共406名研究参与者中,27.5%(n = 112)在MAV/06-MAV/06组,30.3%(n = 123)在MAV/06-OKA组,17.5%(n = 71)在OKA-MAV/06组,24.6%(n = 100)在OKA-OKA组。第一剂免疫时的平均年龄为1.10(标准差[SD]±0.34)岁,第二剂为4.77(SD±1.13)岁(分别为0.772和0.933)。在国家VAERS中,没有第二剂接种后不良事件的存档报告。医院就诊记录显示,共有10.3%(95%置信区间[CI],7.6-13.7)(n = 42)在接种第二剂后记录了不良事件;然而,只有0.7%(95%CI,0.2-2.4)(n = 3)被认为可能与疫苗有关。MAV/06-OKA组的两名患者在接种第二剂后被诊断为过敏性紫癜;然而,两人在同一天也接种了MMR疫苗。在这个健康儿童患者队列中,未观察到与互换MAV/06和OKA毒株减毒活水痘疫苗相关的安全信号。

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