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| Surveillance of adverse event following immunization with 13-valent pneumococcal polysaccharide conjugate vaccine in Jiaxing City |
| XU Rongquan, DU Zhequn, YU Pengfei, SHEN Guochu, HU Jie, ZHANG Yangchun
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| Department of Immunization Planning, Jiaxing Center for Disease Control and Prevention,Jiaxing, Zhejiang 314050, China |
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Abstract Objective To investigate the incidence of adverse event following immunization (AEFI) with 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) in Jiaxing City, Zhejiang Province, so as to provide insights into safety monitoring and evaluation of PCV13. Methods Surveillance data of AEFI with PCV13 in Jiaxing City from 2020 to 2022 were collected from the AEFI Monitoring Information Management System of the Immunization Planning System of Chinese Disease Prevention and Control Information System, including demographic information, vaccination time, time of AEFI occurrence and clinical symptoms, and the reported incidence, population and district distribution, and clinical symptoms of AEFI with PCV13 were descriptively analyzed. Results Totally 455 cases of AEFI with PCV13 were reported in Jiaxing City from 2020 to 2022, with a reported incidence rate of 232.33/105 doses. There were 431, 21 and 3 cases of general, abnormal, coincidence and psychogenic reactions, with reported incidence rates of 220.07/105 doses, 10.72/105 doses and 1.53/105 doses, respectively, and no reports of causal reaction, vaccine quality accident and vaccination accident. The AEFI cases included 258 boys and 197 girls, with a boy/girl ratio of 1.31∶1, and 288 children at ages of less than a year (63.30%). The largest number of AEFI was reported in Haining City (87 cases, 19.12%), and there were 349 AEFI cases (76.70%) within 24 hours following vaccination. The clinical symptoms mainly included redness and swelling, fever and induration, with reported incidence rates of 132.76/105 doses (260 cases), 109.27/105 doses (214 cases), and 55.66/105 doses (109 cases), respectively. There were 450 cases cured and 5 cases improved in 455 cases of AEFI. Conclusions General reaction is the predominant AEFI in Jiaxing City from 2020 to 2022, with mild symptoms. Most AEFI occurs within 24 hours following vaccination, and has a good prognosis.
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Received: 03 January 2024
Revised: 07 March 2024
Published: 17 May 2024
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[1] World Health Organization.Pneumococcal conjugate vaccines in infants and children under 5 years of age[EB/OL].[2024-03-07].https://iris.who.int/bitstream/handle/10665/310968/WER9408.pdf?sequence=1.
[2] CAI K,WANG Y Z,GUO Z Q,et al.Clinical characteristics and antimicrobial resistance of pneumococcal isolates of pediatric invasive pneumococcal disease in China[J].Infect Drug Resist,2018,11:2461-2469.
[3] 朱琳,高静,柏丁兮,等.中国居民肺炎球菌疫苗接种意愿的Meta分析[J].预防医学,2021,33(9):935-939,943.
[4] 国家卫生健康委员会,国家药品监督管理局.全国疑似预防接种异常反应监测方案(2022版)[S].2022.
[5] 杨守飞,黄卓英,任佳,等.2010—2020年上海市肺炎疫苗的疑似预防接种异常反应报告的分析[J].上海预防医学,2021,33(6):548-552.
[6] 杜冰会,杨凯朝,史鲁斌,等.2017—2021年河南省肺炎球菌疫苗疑似预防接种异常反应监测[J].现代疾病预防控制,2023,34(4):246-249.
[7] 王晓柳,汤元妃.2018—2021年武义县疑似预防接种异常反应监测结果[J].预防医学,2022,34(11):1167-1171,1177.
[8] 倪莉红,张春焕,卢惠溪,等.新型冠状病毒肺炎疫情及疫苗大规模应急接种对儿童家长常规免疫观念和体验的影响[J].医学动物防制,2023,39(5):423-428.
[9] 张超,沈建勇,罗小福,等.2015—2021年湖州市MMR疫苗疑似预防接种异常反应监测结果[J].预防医学,2023,35(1):74-77.
[10] 杨守飞,刘捷宸,黄卓英,等.上海市13价肺炎球菌多糖结合疫苗联合接种的安全性分析[J].上海预防医学,2022,34(8):751-755.
[11] 叶莉霞,马瑞,方挺,等.宁波市儿童肺炎球菌多糖结合疫苗疑似预防接种异常反应监测[J].中国疫苗和免疫,2019,25(4):454-457.
[12] HU R,LIU Y B,ZHANG L,et al.Post-marketing safety surveillance for both CRM197 and TT carrier proteins PCV13 in Jiangsu,China[J].Front Public Health,2023,11:1-7.
[13] HU Y,PAN X J,CHEN F X,et al.Surveillance of adverse events following immunization of 13-valent pneumococcal conjugate vaccine among infants,in Zhejiang province,China[J].Hum Vaccin Immunother,2022,18(1):1-7.
[14] GOLDBLATT D,SOUTHERN J,ANDREWS N J,et al.Pneumococcal conjugate vaccine 13 delivered as one primary and one booster dose(1+1)compared with two primary doses and a booster(2+1)in UK infants:a multicentre,parallel group randomised controlled trial[J].Lancet Infect Dis,2023,41(19):3019-3023.
[15] POMAT W S,VAN DEN BIGGELAAR A H J,WANA S,et al.Safety and immunogenicity of pneumococcal conjugate vaccines in a high-risk population:a randomized controlled trial of 10-valent and 13-valent pneumococcal conjugate vaccine in Papua New Guinean infants[J].Clin Infect Dis,2019,68(9):1472-1481. |
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