Safety evaluation of vaccines containing DTaP in age-eligible children from 2020 to 2022 in Jilin Province
10.13200/j.cnki.cjb.004517
- VernacularTitle:2020—2022年吉林省适龄儿童接种含无细胞百白破成分疫苗的安全性评价
- Author:
CHENG Tao
- Publication Type:Journal Article
- Keywords:
Diphtheria,tetanus and acellular pertussis combined vaccine(DTaP);
Diphtheria,tetanus,acellular pertussis and Haemophilus influenzae type b combined vaccine(DTaP-Hib);
Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine and Haemophilus type b conjugate vaccine,adsorbed(DTaP-IPV/Hib);
Immunization;
Adverse event following immunization(AEFI)
- From:
Chinese Journal of Biologicals
2025;38(07):808-814
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety of age-eligible children vaccinated with vaccines containing diphtheria, tetanus and acellular pertussis combined vaccine(DTaP) in Jilin Province from 2020 to 2022, so as to provide references for the safe use of vaccines in follow-up vaccination work.Methods Data on individual cases of adverse event following immunization(AEFI) in age-eligible children vaccinated with diphtheria, tetanus and acellular pertussis combined vaccine(DTaP), diphtheria, tetanus,acellular pertussis and Haemophilus influenzae type b combined vaccine(DTaP-Hib) and diphtheria, tetanus,pertussis(acellular, component), poliomyelitis(inactivated) vaccine and Haemophilus type b conjugate vaccine, adsorbed(DTaP-IPV/Hib) in Jilin Province from January 1, 2020 to December 31, 2022 were collected through the AEFI system of the Jilin Provincial Immunization Program Information Management System and the National Immunization Program Information System. A descriptive epidemiological approach was employed for analysis, and statistical methods were applied to compare differences between groups.Results Age-eligible children in Jilin Province from 2020 to 2022 were inoculated with DTaP,DTaP-Hib and DTaP-IPV/Hib vaccines 1 301 812 doses. A total of 3 132 AEFI cases(240. 59 per 100 000 doses) were reported. 3 122 common adverse reaction cases(99. 68%, 239. 82 per 100 000 doses), 7 rare adverse reaction cases(0. 22%,0. 54 per 100 000 doses) and 3 coupling reaction cases(0. 1%, 0. 23 per 100 000 doses) were reported in the study. The incidence rates of AEFI cases of 3 vaccines containing DTaP were 257. 00 per 100 000 doses(3 025 cases), 175. 61 per 100 000doses(34 cases) and 69. 26 per 100 000 doses(73 cases), with statistically significant difference(χ~2= 145. 53, P < 0. 001).The incidence rates of AEFI cases for the booster immunization of 3 vaccines containing DTaP were higher than the basic immunization and the difference was statistically significant(χ~2= 254. 98, 18. 03 and 20. 39, respectively, each P < 0. 05).The reported AEFI cases were mainly common adverse reactions,inclucding fever, local redness and swelling, local induration and so on, and occurred mainly within 0 to 1 day after vaccination.Conclusion AEFI of age-eligible children vaccinated with DTaP, DTaP-Hib and DTaP-IPV/Hib in Jilin Province from 2020 to 2022 was mainly common adverse reaction, and the overall safety was good. It is suggested that AEFI monitoring after vaccination should be continuously strengthened and passive monitoring system should be optimized to reduce underreporting bias.
