Safety analysis of different types of hepatitis B vaccines in Fujian Province, 2019-2023
10.13200/j.cnki.cjb.004476
- VernacularTitle:2019—2023年福建省不同品种乙型肝炎疫苗安全性分析
- Author:
LIN Zhiqiang
- Publication Type:Journal Article
- Keywords:
Adverse events following immunization(AEFI);
Hepatitis B vaccine;
Safety
- From:
Chinese Journal of Biologicals
2025;38(05):569-573+580
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the epidemiological characteristics of adverse events following immunization(AEFI) ofthree types of hepatitis B vaccines(CHO, Saccharomyces cerevisiae and Hansenula polymorpha) in Fujian Province from 2019to 2023, and evaluate their safety. Methods The AEFI case data and vaccination data of hepatitis B vaccines reported inFujian Province from 2019 to 2023 were collected through the Chinese Immunization Planning Information ManagementSystem. The occurrence characteristics, incidence rates and other indicators of AEFI related to hepatitis B vaccines wereanalyzed by using descriptive analysis methods. Results In Fujian Province from 2019 to 2023, there were 677 reportedcases of AEFI related to hepatitis B vaccines, with an AEFI reported incidence of 7. 44 per 100 000 doses. The male-to-female ratio was 1. 20∶1, and the age distribution was mainly in the group of less than 1 year old. The reported incidence ofcommon adverse reactions was 6. 24 per 100 000 doses, and the reported incidence of rare adverse reactions was 0. 96 per100 000 doses. Rare vaccine reaction cases were mainly anaphylactic reaction. There were statistically significant differencesin the reported incidence of common adverse reactions and allergic skin rashes among the three types of hepatitis B vaccines(χ~2= 111. 587 and 13. 284, respectively, each P < 0. 05). Conclusion The reported incidence of AEFI related to hepatitisB vaccines in Fujian Province has been rare from 2019 to 2023, falling within the expected range of WHO, indicating goodsafety of the vaccines.