Analysis of surveillance data of suspected adverse events following immunization in Fujian Province from 2011 to 2015
10.3760/cma.j.issn.1008-5734.2019.05.008
- VernacularTitle:福建省2011-2015年疑似预防接种异常反应监测数据分析
- Author:
Zhiqiang LIN
1
;
Ruihong WU
;
Jianxiong XIAO
;
Yong ZHOU
;
Shanying ZHANG
;
Kuicheng ZHENG
Author Information
1. 福建省疾病预防控制中心,福建省人兽共患病重点实验室,福州350001
- Publication Type:Journal Article
- Keywords:
Vaccines;
Vaccination;
Immunization programs;
Drug-related side effects and adverse reactions;
Adverse drug reaction reporting systems
- From:
Adverse Drug Reactions Journal
2019;21(5):353-359
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety of national immunization program (NIP) vaccines and non-NIP vaccines in Fujian Province from 2011 to 2015.Methods The 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 nonNIP 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.Results From 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.Conclusion From 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.
