Systematic review and Meta analysis of real-world safety of Sabin and Salk strain inactivated poliovirus vaccines
10.13200/j.cnki.cjb.004680
- VernacularTitle:Sabin株和Salk株脊髓灰质炎灭活疫苗真实世界安全性的系统综述和Meta分析
- Author:
Feng SU
1
Author Information
1. China National Biotec Group Company Limited, Beijing 100024, China
- Publication Type:Journal Article
- Keywords:
Inactivated poliovirus vaccine(IPV);
Sabin strain;
Salk strain;
Safety;
Real-world study;
Systematic review;
Meta analysis
- From:
Chinese Journal of Biologicals
2026;39(04):421-429
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the post-vaccination safety of Sabin and Salk strain inactivated poliovirus vaccines(IPVs)in the real-world settings, and to provide evidence-based basis for scientific formulation of vaccination strategies and subsequent development of safer and more effective polio vaccines.MethodsThe study followed the PRISMA statement,searched multiple databases including China National Knowledge Infrastructure(CNKI), Wanfang Database, Embase, Web of Science, PubMed, etc., and collected surveillance data on adverse events following immunization(AEFI) from the Chinese Centers for Disease Control and Prevention(CDCs) at or above the provincial level. The included studies were able to extract data to display safety information of different AEFI classification data. After screening, a total of 19 documents were included in the final analysis, all of which were cross-sectional studies.ResultsThe included studies showed that the overall AEFI incidence of the two strains of IPV vaccines used in China was 29. 9/10~5 doses[95% CI:(22. 4-40. 0)/10~5 doses]. Comparing the national and provincial monitoring studies, there were significant differences in incidence rates of fever, thrombocytopenic purpura(TP), and febrile convulsions(P = 0. 002, 0. 016 and 0. 001, respectively), which were 6. 2/10~5 doses[95% CI:(4. 6-8. 4)/10~5 dose]vs 22. 1/10~5 doses[95% CI:(14. 4-34. 1)/10~5 doses], 0. 08/10~5 doses[95% CI:(0. 07-0. 11)/10~5 doses]vs 0. 29/10~5 doses[95% CI:(0. 20-0. 42)/10~5 doses], and 0. 03/10~5 doses[95% CI:(0. 02-0. 05)/10~5 doses]vs0. 25/10~5 doses[95% CI:(0. 16-0. 40)/10~5 doses], respectively. There was no significant difference in the incidence of AEFI, general reac-tions, abnormal reactions, febrile reactions, allergic rashes, TP, and febrile convulsions between Sabin and Salk strains in the provincial study. Sensitivity analysis showed that the results were robust and publication bias was not obvious.ConclusionBoth strains of IPV vaccines used in the Chinese market have good safety, and China's domestic Sabin strain IPV and imported Salk strain IPV vaccines have similar safety profiles.
