摘要
目的对2020年重庆市和陕西省接种0.5 mL/瓶的冻干甲型肝炎减毒活疫苗的疑似预防接种反应(adverse event following immunization,AEFI)报告病例进行分析,再评价其安全性。方法用回顾分析方法,分析中国疾病预防控制信息系统和国家免疫规划信息系统接种0.5 mL/瓶的冻干甲型肝炎减毒活疫苗AEFI报告病例中,一般反应、异常反应、报告病例疫苗批号、接种到发病时间间隔及转归的情况。结果两地接种冻干甲型肝炎减毒活疫苗565615剂次,AEFI报告病例106例,AEFI报告发生率18.74/10万剂次。一般反应报告发生率最高,为17.33/10万剂次;心因性反应、疫苗质量事故和接种事故均未有报告。两地一般反应报告病例共98例,发生率分别为1.77/10万剂次、23.87/10万剂次;发热病例最多,有83例,报告发生率为14.67/10万剂次。异常反应包括过敏性皮疹、荨麻疹,共报告病例7例,报告发生率为1.24/10万剂次。其中,过敏性皮疹报告病例6例,报告发生率1.06/10万剂次;荨麻疹报告病例1例,报告发生率为0.18/10万剂次。两省(市)接种冻干甲型肝炎减毒活疫苗共12个批号,一般反应和异常反应报告病例的疫苗批号均无聚集性。重庆市AEFI报告病例9例,接种到发病时间间隔主要集中在0 d(接种当天);陕西省AEFI报告病例97例,其中40例发生在接种的当天,40例发生在接种后1 d。两省(市)的一般反应、异常反应和偶合症均已痊愈或好转,转归情况良好,无后遗症。结论2020年两地接种的冻干甲型肝炎减毒活疫苗AEFI报告病例较少,报告率较低,无严重的异常反应,绝大多数不良反应的症状轻微,多为一过性。0.5 mL冻干甲型肝炎减毒活疫苗工艺变更后,疫苗质量得到很大提升,具有良好的安全性,适合在适龄人群进行大规模的免疫接种。
Objective The present study aims to analyze reported cases of adverse event following immunization(AEFI) of freeze-dried live attenuated hepatitis A vaccine inoculated with 0.5 mL/bottle in Chongqing City and Shaanxi Province in 2020, and to re-evaluate safety of the vaccine. Methods The retrospective analysis method was used to analyze general reaction, abnormal reaction, vaccine batch numbers, time interval between vaccination and onset of disease, and outcome of the AEFI cases collected through the China Disease Prevention and Control Information System and the National Immunization Program Information System. Results The two places were inoculated with 565 615 doses of freeze-dried live attenuated hepatitis A vaccine, 106 cases of AEFI were reported, and the reported incidence of AEFI was 18.74/10;doses. The incidence of general reaction reports was the highest as 17.33/10;doses;psychogenic reactions, vaccine quality accidents and vaccination accidents were not reported. A total of 98 cases of general reaction were reported in Chongqing City and Shaanxi Province, with the incidence of 1.77/10;doses and 23.87/10;doses, respectively;the fever cases were the most, with 83 cases, and the reported incidence was 14.67/10;doses. Abnormal reactions including allergic rash and urticaria reported on 7 cases, and the reported incidence was 1.24/10;doses. A total of 12 batches of freeze-dried live attenuated hepatitis A vaccine were counted, indicating absence of clusters in common and abnormal reaction. 9 cases of AEFI were reported in Chongqing, and the time interval from vaccination to onset was mainly concentrated at 0 d(the day of vaccination);97 cases of AEFI were reported in Shaanxi Province, of which 40 cases occurred on day 0 of vaccination and 40 cases occurred on day 1 after vaccination. People with general reactions, abnormal reactions and incidents in the two places were successfully cured without sequelae. Conclusion Vaccination of freeze-dried hepatitis A(Live) vaccine within the dosage of 0.5 mL/bottle in population of Chongqing City and Shaanxi Province shows a low AEFI incidence. The symptoms of most adverse reactions are mild and mostly transient, and there are no serious abnormal reactions. The vaccine has an acceptable safety profile, and is suitable for large-scale immunization in the right age group.
作者
赵淑洁
夏娇慧
王辰皓
张适轩
姜崴
郭雪
ZHAO Shu-jie;XIA Jiao-hui;WANG Chen-hao;ZHANG Shi-xuan;JIANG Wei;GUO Xue(Department of medical affairs,Changchun Instinute of Biological Products Co..Iud.Changchun 130012,Jilin Prorince,China)
出处
《微生物学免疫学进展》
CAS
2021年第6期52-56,共5页
Progress In Microbiology and Immunology
基金
吉林省科技发展计划项目(201603007YY)。
关键词
冻干甲型肝炎减毒活疫苗
上市后
安全性
不良反应
Freeze-dried live attenuated hepatitis A vaccine
Post marketing
Safety
Adverse reaction
