北京市适龄儿童13价肺炎球菌多糖结合疫苗和口服五价轮状病毒减毒活疫苗同时接种的上市后安全性监测

Post-marketing safety of co-administration of 13-valent pneumococcal polysaccharide conjugate vaccine and oral pentavalent rotavirus attenuated live vaccine in age-eligible children in Beijing

目的了解13价肺炎球菌多糖结合疫苗(PCV13)与口服五价轮状病毒减毒活疫苗(RV5)同时接种的上市后安全性。方法通过北京市相关信息管理系统收集2020年出生儿童PCV13和RV5接种剂次数和疑似预防接种异常反应(AEFI),比较适龄儿童两种疫苗同时接种和单独接种的AEFI报告发生率。结果适龄儿童PCV13与RV5同时接种、PCV13单独接种、RV5单独接种的AEFI报告发生率分别为0.64‰(36例)、0.54‰(28例)、1.06‰(7例)(χ^(2)=2.72,P=0.257);其中一般反应分别为0.37‰(21例)、0.40‰(21例)、0.46‰(3例)(χ^(2)=0.13,P=0.935),异常反应分别为0.09‰(5例)、0.08‰(4例)、0.15‰(1例)(χ^(2)=0.39,P=0.825);严重AEFI分别为0.02‰(1例)、0.00‰、0.00‰(χ^(2)=1.04,P=0.593),非严重AEFI分别为0.62‰(35例)、0.54‰(28例)、1.06‰(7例)(χ^(2)=2.69,P=0.261)。所有AEFI均治愈或好转。结论适龄儿童PCV13和RV5同时接种未增加AEFI发生风险。

Objective To assess post-marketing safety of co-administration of 13-valent pneumococcal polysaccharide conjugate vaccine(PCV13) and oral pentavalent rotavirus attenuated live vaccine(RV5).Methods We obtained data on vaccination and adverse events following immunization(AEFIs) with PCV13 and RV5 among children born in 2020 from relevant information management systems in Beijing. We compared reported AEFI incidence rates among age-eligible children who received the two vaccines simultaneously and separately.Results Reported incidence rates of AEFIs were 0.64‰(36 cases), 0.54‰(28 cases), and 1.06‰(7 cases)(χ^(2)=2.72, P=0.257) among age-eligible children vaccinated with PCV13 and RV5 simultaneously, PCV13 standalone, and RV5 standalone, respectively. Incidence rates in the three groups for common adverse reactions were 0.37‰(21 cases), 0.40‰(21 cases), and 0.46‰(3 cases)(χ^(2)=0.13, P=0.935);for rare adverse reactions were 0.09‰(5 cases), 0.08‰(4 cases), and 0.15‰(1 case)(χ^(2)=0.39, P=0.825);for serious AEFIs were 0.02‰(1 case), 0.00‰, and 0.00‰(χ^(2)=1.04, P=0.593);and for non-serious AEFIs were 0.62‰(35 cases), 0.54‰(28 cases), and 1.06‰(7 cases)(χ^(2)=2.69, P=0.261). All AEFIs recovered or improved.Conclusions Co-vaccination of PCV13 and RV5 in age-eligible children did not increase risk of AEFIs.