目的:2016年5月1日将一剂萨宾株脊髓灰质炎灭活疫苗(IPV)引入中国免疫规划。本研究旨在评估Sabin菌株IPV的安全性,并与常规Salk菌株IPV进行比较。
方法:从2016年5月1日至2020年12月31日的国家AEFI监测系统(NAEFSS)中提取与Sabin株IPV和Salk株IPV相关的免疫接种后不良事件(AEFI)记录。从浙江省免疫信息系统获得同期Sabin株IPV和Salk株IPV的疫苗接种信息。AEFI的报告率按年龄计算,城市,AEFI的严重性,AEFI的类别,和反应类别,并在Sabin菌株IPV和Salk菌株IPV之间进行了比较。
结果:总计,在研究期间施用3,861,758剂量的Sabin菌株IPV和1,018,604剂量的Salk菌株IPV。Sabin株IPV的总体AEFI报告率(3.96/10,000剂量)显着低于Salk株IPV(5.03/10,000剂量),这是由于Sabin株IPV后次要疫苗产品相关反应的报告率明显低于Salk株IPV(2.76/10,000剂量vs.3.83/10000剂)。最常报告的症状/体征是发烧,硬结/肿胀,和皮疹/荨麻疹。最常见的有因果关系的严重AEFI是高热惊厥,Sabin菌株IPV的报告率为0.10/10,000剂量,Salk菌株IPV的报告率为0.08/10,000剂量。在两种类型的IPV之间,其他严重的AEFI的报告率没有发现显着差异。
结论:Sabin菌株IPV和Salk菌株IPV后的大多数AEFI均为轻度和常见的不良反应。Sabin菌株IPV和Salk菌株IPV之间严重AEFI的报告率没有显着差异。Sabin菌株IPV具有良好的安全性,可以广泛使用。
OBJECTIVE: One dose of Sabin-strains inactivated polio vaccine (IPV) was introduced into the Chinese immunization program on 1 May 2016. This study aimed to evaluate the safety of Sabin-strains IPV and provide a comparison with conventional Salk-strains IPV.
METHODS: Adverse events following immunization (AEFI) records associated with Sabin-strains IPV and Salk-strains IPV were extracted from the national AEFI surveillance system (NAEFISS) from 1 May 2016 to 31 December 2020. The vaccination information on Sabin-strains IPV and Salk-strains IPV during the same period was obtained from the Zhejiang provincial immunization information system. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories and were compared between Sabin-strains IPV and Salk-strains IPV.
RESULTS: In total, 3,861,758 doses of Sabin-strains IPV and 1,018,604 doses of Salk-strains IPV were administered during the study period. The overall AEFI reporting rate for Sabin-strains IPV (3.96/10,000 doses) was significantly lower than that for Salk-strains IPV (5.03/10,000 doses) due to the reporting rate of the minor vaccine product-related reaction following Sabin-strains IPV was significantly lower than that for Salk-strains IPV (2.76/10,000 doses vs. 3.83/10,000 doses). The most frequently reported symptoms/signs were fever, induration/swelling, and rash/urticaria. The most frequently reported serious AEFI with a causal relationship was febrile convulsion, with the reporting rates of 0.10/10,000 doses for Sabin-strains IPV and 0.08/10,000 doses for Salk-strains IPV. No significant difference was found in the reporting rates of the other serious AEFI between the two types of IPV.
CONCLUSIONS: Most of the AEFI following Sabin-strains IPV and Salk-strains IPV were mild and common adverse reactions. The reporting rate of serious AEFI was not significantly different between Sabin-strains IPV and Salk-strains IPV. Sabin-strains IPV had a favorable safety profile and could be widely used.