Analysis of surveillance data of suspected adverse events following immunization in Fujian Province from 2011 to 2015
Fujian Provincial Key Laboratory of Zoonosis Research, Fujian Provincial Center for Disease Control and Prevention, Fuzhou 350001, China; Teaching Base, Public Health School of Fujian Medical University, Fuzhou 350122, China
Abstract：ObjectiveTo evaluate the safety of national immunization program (NIP) vaccines and non-NIP vaccines in Fujian Province from 2011 to 2015.MethodsThe adverse events following immunization (AEFI) case information reported in Fujian Province from 2011 to 2015 was collected from the National AEFI Information Management System and vaccination data of NIP vaccines (11 species) and non-NIP vaccines (19 species) in the same period in Fujian Province were collected from the National Immunization Program Information Management System. The collected monitoring data were descriptively analyzed. The total and severe AEFI reporting rates and their 95% confidence intervals (CI) were calculated.ResultsFrom 2011 to 2015, a total of 70 976 300 doses of vaccines were inoculated in Fujian Province and a total of 8 987 cases of AEFI were reported, including 192 cases (2.14%) of severe AEFI. The incidence (95%CI) of reported AEFI was 12.66 (12.40-12.93) per 100 000 doses and the incidence (95%CI) of reported severe AEFI was 2.71 (2.34-3.12) per one million doses. A total of 55 702 100 doses of NIP vaccines were inoculated and 7 347 cases of AEFI were reported, of which 138 (1.88%) were severe AEFI cases. The incidence (95%CI) of reported AEFI was 13.19 (12.89-1.49) per 100 000 doses of NIP vaccines and the incidence (95%CI) of reported severe AEFI was 2.48 (2.08-2.93) per one million doses. Among the 11 NIP vaccines, the incidence (95%CI) of reported AEFI ranged from 0.95 (0.88-1.13) per 100 000 doses to 43.71 (40.72-46.75) per 100 000 doses and the incidence (95%CI) of reported severe AEFI ranged from 1.04 (0.32-1.76) per one million doses to 6.41 (2.78-10.04) per one million doses. A total of 15 271 600 doses of non-NIP vaccines were inoculated and 1 640 cases of AEFI were reported, of which 54 (3.54%) were severe AEFI cases. The total incidence (95%CI) of reported AEFI was 10.74 (10.23-11.27) per 100 000 doses and the incidence (95%CI) of reported severe AEFI was 3.54 (2.66-4.61) per one million doses. Among the 19 non-NIP vaccines, the incidence (95%CI) of reported AEFI ranged from 2.06 (0.38-3.71) per 100 000 doses to 45.22 (35.29-55.10) per 100 000 doses and the incidence (95%CI) of reported severe AEFI ranged from 0.52 (0-1.53) per one million doses to 20.89 (0-44.51) per one million doses.ConclusionFrom 2011 to 2015, the incidences of reported AEFI and severe AEFI for NIP and non-NIP vaccines circulated in Fujian Province were low, which had good safety.
林志强，吴瑞红，萧剑雄，周勇，张山鹰，郑奎城. 福建省2011—2015年疑似预防接种异常反应监测数据分析[J]. 药物不良反应杂志, 2019, 21(5): 353-359.
Lin Zhiqiang, Wu Ruihong, Xiao Jianxiong, Zhou Yong, Zhang Shanying, Zheng Kuicheng. Analysis of surveillance data of suspected adverse events following immunization in Fujian Province from 2011 to 2015. Adverse Drug Reactions Journal, 2019, 21(5): 353-359.
