湖北省新型冠状病毒疫苗与乙型肝炎疫苗前后接种的安全性回顾性分析

Retrospective analysis of the safety of pre-and post-vaccination of COVID-19 vaccine and Hepatitis B vaccine in Hubei province

目的回顾性分析湖北省新型冠状病毒疫苗与乙型肝炎疫苗(乙肝疫苗)前后接种(间隔60 d内)的疑似预防接种异常反应(adverse events following immunization,AEFI)发生情况,评价新型冠状病毒疫苗与乙肝疫苗前后接种的安全性。方法通过“湖北省免疫规划信息系统”筛选出2020—2022年有新型冠状病毒疫苗与乙肝疫苗前后接种(间隔60 d内)记录的3岁以上人群的个案数据,与“AEFI信息系统”的个案信息进行匹配;以AEFI发生率为评价指标,采用描述性流行病学方法分析AEFI特征。结果2020—2022年湖北省3岁以上人群新型冠状病毒疫苗与乙肝疫苗前后接种(间隔60 d内)合计581337剂次,共报告AEFI 157例次,总体AEFI发生率为0.270‰(罕见)。乙肝疫苗(CHO)和新型冠状病毒疫苗(腺病毒载体)前后接种AEFI发生率最高(5.629‰),不同疫苗组合AEFI发生率差异有统计学意义(χ^(2)=23.737,P=0.014)。中部地区AEFI发生率最高(0.395‰),不同地区AEFI发生率差异有统计学意义(χ^(2)=29.892,P<0.001)。不同前后接种时间间隔AEFI发生率差异无统计学意义(P>0.05)。一般反应中,临床诊断为发热、红肿、硬结的发生率最高(0.229‰),不同临床诊断AEFI发生率差异有统计学意义(χ^(2)=384.375,P<0.001);异常反应和偶合症中,不同临床诊断AEFI发生率差异均无统计学意义(P值均>0.05)。从人群分布来看,不同性别AEFI发生率差异无统计学意义(P>0.05);3~<18岁年龄组AEFI发生率最高(0.158‰),不同年龄组AEFI发生率差异有统计学意义(χ^(2)=85.473,P<0.001);职业为托幼儿童的AEFI发生率最高(0.100‰),不同职业AEFI发生率差异有统计学意义(χ^(2)=116.380,P<0.001)。结论新型冠状病毒疫苗与乙肝疫苗前后接种(间隔60 d内)的AEFI发生率属于罕见,新型冠状病毒疫苗与乙肝疫苗可以同时接种,疫苗安全性良好。

Objective To retrospectively analyze on the occurrence of suspected adverse events following immunization(AEFI)before and after the COVID-19 vaccine and hepatitis B vaccine(with 60 days)in Hubei province,and evaluate the safety of COVID-19 vaccine and Hepatitis B vaccine before and after inoculation.Methods The case data of people aged 3 and above with records of vaccination before and after the COVID-19 vaccine and hepatitis B vaccine(within 60 days)from 2020 to 2022 were screened out from the“Hubei Province Immunization Program Information System”and matched with the case information of the“AEFI Information System”.The incidence of AEFI was used as the evaluation index,and descriptive epidemiological methods were used to analyze the characteristics of AEFI.Results From 2020 to 2022,a total of 581337 doses of COVID-19 vaccine and hepatitis B vaccine were administered before and after vaccination(within 60 days)in people aged 3 years and older in Hubei province,with a total of 157 AEFI cases reported,and the overall incidence of AEFI was 0.270‰(rare).The incidence of AEFI before and after vaccination with hepatitis B vaccine(CHO)and COVID-19 vaccine(adenovirus vector)was the highest(5.629‰).The incidence of AEFI were significantly different among different vaccine combinations(χ^(2)=23.737,P=0.014).The incidence of AEFI was the highest in the central region(0.395‰),and the incidence of AEFI in different regions were significantly different(χ^(2)=29.892,P<0.001).There were no significant difference in the incidence of AEFI between different time intervals before and after vaccination(P>0.05).Among the general reactions,the incidence of clinically diagnosed fever,redness,and induration were the highest(0.229‰).The incidence of AEFI in different clinical diagnoses were statistically significant(χ^(2)=384.375,P<0.001).In abnormal reactions and couplings,there were no significant difference in the incidence in different clinical diagnoses(P>0.05).In terms of population distribution,there were no significant difference in the incidence of AEFI between different genders(P>0.05).The incidence of AEFI was the highest in the age group from 3~<18 years old(0.158‰).The incidence of AEFI in different age groups were statistically significant(χ^(2)=85.473,P<0.001).The incidence of AEFI was the highest in children with childcare occupation(0.100‰),there were statistical significance in the incidence of AEFI among different occupations(χ^(2)=116.380,P<0.001).Conclusions The incidence of AEFI is rare when COVID-19 vaccine and Hepatitis B vaccine before and after inoculation(within 60 days),and the vaccines can be inoculated at the same time with safety.