Real-world meta-analysis of the safety of domestically produced rotavirus vaccine
10.3760/cma.j.cn112309-20240131-00042
- VernacularTitle:国产轮状病毒疫苗接种安全性的真实世界Meta分析
- Author:
Feng SU
1
;
Yunzhi SHI
;
Min XU
;
Mu LI
;
Jun CHEN
;
Yifei HUO
;
Yifeng CHEN
;
Jie ZHAO
;
Jinfeng SU
Author Information
1. 中国生物技术股份有限公司人用疫苗事业部，北京 100024
- Keywords:
Live-attenuated oral rotavirus vaccine;
Adverse event following immunization;
Real-world studies;
Meta-analysis
- From:
Chinese Journal of Microbiology and Immunology
2024;44(5):431-440
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the real-world safety of the domestic rotavirus attenuated live vaccine in China.Methods:Studies on the incidence of adverse event following immunization (AEFI) published from January 1, 2020 to July 31, 2023 were retrieved from National Knowledge Infrastructure (CNKI), CQVIP, Wanfang Database, PubMed, Medline, and Embase. Surveillance data about AEFI reports related to the domestic rotavirus vaccine rotavirus were collected. A meta-analysis on the safety of the rotavirus vaccine after vaccination was conducted using R software, and subgroup analyses were conducted on the incidence of AEFI in different regions and time periods.Results:A total of 36 articles were included involving 25.332 million doses of vaccine. The incidence of AEFI associated with the domestic rotavirus vaccine was 19/100 000 doses [95%CI: 15/100 000-24/100 000 doses]; the incidence was 26/100 000 doses [95%CI: 17/100 000-39/100 000 doses] in the northern regions and 16/100 000 doses [95%CI: 11/100 000-23/100 000 doses] in the southern regions; it was 24/100 000 doses [95%CI: 12/100 000-45/100 000 doses] before 2017 and 27/100 000 doses [95%CI: 18/100 000-39/100 000 doses] after 2017.Conclusions:The incidence of AEFI related to the domestic rotavirus vaccine is within the expected range, and the safety of the vaccine is good based on the real-world data.
