Abstract
Objectives: One dose of Sabin-strains inactivated polio vaccine (IPV) was introduced into the Chinese immunization program on 1 May 2016. This study aimed to evaluate the safety of Sabin-strains IPV and provide a comparison with conventional Salk-strains IPV. Methods: Adverse events following immunization (AEFI) records associated with Sabin-strains IPV and Salk-strains IPV were extracted from the national AEFI surveillance system (NAEFISS) from 1 May 2016 to 31 December 2020. The vaccination information on Sabin-strains IPV and Salk-strains IPV during the same period was obtained from the Zhejiang provincial immunization information system. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories and were compared between Sabin-strains IPV and Salk-strains IPV. Results: In total, 3,861,758 doses of Sabin-strains IPV and 1,018,604 doses of Salk-strains IPV were administered during the study period. The overall AEFI reporting rate for Sabin-strains IPV (3.96/10,000 doses) was significantly lower than that for Salk-strains IPV (5.03/10,000 doses) due to the reporting rate of the minor vaccine product-related reaction following Sabin-strains IPV was significantly lower than that for Salk-strains IPV (2.76/10,000 doses vs. 3.83/10,000 doses). The most frequently reported symptoms/signs were fever, induration/swelling, and rash/urticaria. The most frequently reported serious AEFI with a causal relationship was febrile convulsion, with the reporting rates of 0.10/10,000 doses for Sabin-strains IPV and 0.08/10,000 doses for Salk-strains IPV. No significant difference was found in the reporting rates of the other serious AEFI between the two types of IPV. Conclusion: Most of the AEFI following Sabin-strains IPV and Salk-strains IPV were mild and common adverse reactions. The reporting rate of serious AEFI was not significantly different between Sabin-strains IPV and Salk-strains IPV. Sabin-strains IPV had a favorable safety profile and could be widely used.
Highlights
Introduction published maps and institutional affilThe strategy of switching from the trivalent oral live attenuated polio vaccineto the bivalent OPV, withdrawing the type II strain, was recommended by the PolioEradication and Endgame Strategic Plan 2013–2018
Children using the sequential vaccination schedule for Sabin-strains inactivated polio vaccine (IPV) and Salkstrains IPV were not found in this study
This study presented an evaluation of Adverse events following immunization (AEFI) of the domestic Sabin-strains IPV through the national passive surveillance system on AEFI in Zhejiang province, with a time span of 4.5 years after the switch of polio vaccination strategy
Summary
Introduction published maps and institutional affilThe strategy of switching from the trivalent oral live attenuated polio vaccine (tOPV)to the bivalent OPV (bOPV), withdrawing the type II strain, was recommended by the PolioEradication and Endgame Strategic Plan 2013–2018. Organization (WHO) recommended that OPV-using countries should arrange at least one dose of inactivated polio vaccine (IPV) into the routine polio vaccine schedule to prevent the possible outbreaks of polio virus type II or the circulation of vaccine-derived polio virus type II [1]. Based on these strategies, China switched from using tOPV to using bOPV in the routine immunization program and introduced one dose of IPV into the polio vaccine schedule on 1 May 2016, which was synchronized with more than 150 other countries using OPV in their national immunization programs [2]. The new Chinese polio vaccine schedule included one IPV dose given at 2 months of age, followed by three bOPV doses at 3, 4, and 48 months of age [3]. iations.
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