A群C群脑膜炎球菌多糖结合疫苗预防接种不良反应病例报告分析

Analysis on Case Report of Adverse Event Following Immunization of Groups A and C Meningococcal Polysaccharide Conjugate Vaccine

目的:分析A群C群脑膜炎球菌多糖结合疫苗的安全性,提出预防接种不良反应(AEFI)的防治对策。方法:选取2021年3月-2022年3月成都欧林生物科技股份有限公司出库的414730支A群C群脑膜炎球菌多糖结合疫苗接种者为研究对象,分析AEFI发生情况,讨论发生AEFI儿童的年龄、性别、临床表现及联合用药情况。结果:2021年3月-2022年3月成都欧林生物科技股份有限公司共出库A群C群脑膜炎球菌多糖结合疫苗414730支,发生AEFI 7例,发生率为0.169/万剂,均发生在2021年。7例AEFI儿童中,以6~11个月月龄儿童最多,共5例,占71.43%;0~2个月、3~5个月儿童各1例,各占14.29%。7例AEFI儿童中,男3例,女4例,性别占比男∶女为1∶1.3。7例AEFI儿童中,发热6例,累计发生率为0.14/万剂;疫苗接种部位肿胀、皮疹各1例,累计发生率均为0.02/万剂。7例AEFI儿童中,单独使用A群C群脑膜炎球菌多糖结合疫苗5例,联合其他药品使用2例。7例AEFI儿童中,涉及产品批号S-20200401者4例,累计出库47504支,发生率为0.84/万剂;涉及产品批号S-20200402者2例,累计出库51709支,发生率为0.39/万剂;批号不详1例。结论:A群C群脑膜炎球菌多糖结合疫苗的安全性高,AEFI发生率较低。

Objective:To analyze the safety of meningococcal polysaccharide conjugate vaccine of Group A and Group C,and propose the prevention and control countermeasures for adverse event following immunization(AEFI).Methods:From March 2021 to March 2022,the recipients of 414730 meningococcal polysaccharide conjugate vaccines of Group A and group C released by Chengdu Olymvax Biotechnology Co.,Ltd.were selected as the study subjects.The occurrence of AEFI was analyzed.The age,gender,clinical manifestations and combined medication of children with AEFI were discussed.Results:From March 2021 to March 2022,a total of 414730 meningococcal polysaccharide conjugate vaccines of Group A and Group C were released by Chengdu Olymvax Biotechnology Co.,Ltd.,and 7 cases developed AEFI,with an incidence of 0.169/10000 doses,and all AEFIs occurred in 2021.Among the 7 children with AEFI,children aged 6-11 months were predominant,a total of 5 cases,accounting for 71.43%;1 child aged 0-2 months and 1 child aged 3-5 months,accounting for 14.29%each.Among the 7 children with AEFI,there were 3 males and 4 females,and the gender ratio was 1:1.3(male:female).Among the 7 children with AEFI,6 cases had fever,and the cumulative incidence was 0.14/10000 doses.There was 1 case of swelling and rash at the vaccination site,and the cumulative incidence was 0.02/10000 doses.Among the 7 children with AEFI,5 cases received meningococcal polysaccharide conjugate vaccine of Group A and Group C alone,and 2 cases received the combination with other drugs.Among the 7 children with AEFI,4 cases involved product batch number S-20200401,and a total of 47504 units were released from the warehouse,with an incidence of 0.84/10000 doses;2 cases involved product batch number S-20200402,and a total of 51709 units were released from the warehouse,with an incidence of 0.39/10000 doses;1 case had the unknown batch number.Conclusion:Groups A and C meningococcal polysaccharide conjugate vaccine has high safety and low incidence of AEFI.