Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative study in China

To comprehensively assess the safety and difference of two types of EV71 vaccines: EV71-Vero, produced using Vero cells and EV71-H2, using human diploid cells. Our research included children of the recommended age who voluntarily received the EV71 vaccine in Hebei Province from 2019 to 2023. Detaile...

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Main Authors: Yiqing Zhu, Yihan Wang, Jinghui Wang, Yafei Wang, Li Sun, Shiheng Cui, Jing Li, Yu Guo
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:Human Vaccines & Immunotherapeutics
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Online Access:https://www.tandfonline.com/doi/10.1080/21645515.2025.2458831
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author Yiqing Zhu
Yihan Wang
Jinghui Wang
Yafei Wang
Li Sun
Shiheng Cui
Jing Li
Yu Guo
author_facet Yiqing Zhu
Yihan Wang
Jinghui Wang
Yafei Wang
Li Sun
Shiheng Cui
Jing Li
Yu Guo
author_sort Yiqing Zhu
collection DOAJ
description To comprehensively assess the safety and difference of two types of EV71 vaccines: EV71-Vero, produced using Vero cells and EV71-H2, using human diploid cells. Our research included children of the recommended age who voluntarily received the EV71 vaccine in Hebei Province from 2019 to 2023. Detailed data on adverse events following immunization (AEFI) were collected, analyzed and compared for EV71-Vero and EV71-H2 vaccines. With 477 AEFI reported, the reported rate was 14.21 per 100,000 doses. Most cases occurred in infants under one year of age (45.91%). No significant differences in the AEFI reported rate were found between two types of EV71 vaccines across various demographic. However, a higher number of AEFI was reported in children under 1-year old following EV71-Vero compared to EV71-H2 with a reversal in 4–5 years- group (χ2 = 13.90, p = .01). The prognosis of cured took higher proportion for EV71-Vero than for EV71-H2 while inversely with improved outcome. The EV71 vaccine is advisable recommend to the appropriate age children to prevent EV7l infection. Both the EV71-Vero and EV71-H2 vaccines have good safety profiles. The reported AEFI, primarily high fever and allergic reactions, showed no significant differences in reported rates or case characteristics between the two types.
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publishDate 2025-12-01
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spelling doaj-art-6069686433bf42f2bb30091f42bfb4bc2025-02-03T01:09:11ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2458831Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative study in ChinaYiqing Zhu0Yihan Wang1Jinghui Wang2Yafei Wang3Li Sun4Shiheng Cui5Jing Li6Yu Guo7Department of Immunization Management, Hebei Province Center for Disease Prevention and Control, Shijiazhuang, Hebei Province, ChinaDepartment of Immunization Management, Hebei Province Center for Disease Prevention and Control, Shijiazhuang, Hebei Province, ChinaDepartment of Immunization Management, Hebei Province Center for Disease Prevention and Control, Shijiazhuang, Hebei Province, ChinaDepartment of Immunization Management, Hebei Province Center for Disease Prevention and Control, Shijiazhuang, Hebei Province, ChinaDepartment of Immunization Management, Hebei Province Center for Disease Prevention and Control, Shijiazhuang, Hebei Province, ChinaDepartment of Immunization Management, Hebei Province Center for Disease Prevention and Control, Shijiazhuang, Hebei Province, ChinaDepartment of Immunization Management, Hebei Province Center for Disease Prevention and Control, Shijiazhuang, Hebei Province, ChinaDepartment of Immunization Management, Hebei Province Center for Disease Prevention and Control, Shijiazhuang, Hebei Province, ChinaTo comprehensively assess the safety and difference of two types of EV71 vaccines: EV71-Vero, produced using Vero cells and EV71-H2, using human diploid cells. Our research included children of the recommended age who voluntarily received the EV71 vaccine in Hebei Province from 2019 to 2023. Detailed data on adverse events following immunization (AEFI) were collected, analyzed and compared for EV71-Vero and EV71-H2 vaccines. With 477 AEFI reported, the reported rate was 14.21 per 100,000 doses. Most cases occurred in infants under one year of age (45.91%). No significant differences in the AEFI reported rate were found between two types of EV71 vaccines across various demographic. However, a higher number of AEFI was reported in children under 1-year old following EV71-Vero compared to EV71-H2 with a reversal in 4–5 years- group (χ2 = 13.90, p = .01). The prognosis of cured took higher proportion for EV71-Vero than for EV71-H2 while inversely with improved outcome. The EV71 vaccine is advisable recommend to the appropriate age children to prevent EV7l infection. Both the EV71-Vero and EV71-H2 vaccines have good safety profiles. The reported AEFI, primarily high fever and allergic reactions, showed no significant differences in reported rates or case characteristics between the two types.https://www.tandfonline.com/doi/10.1080/21645515.2025.2458831Enterovirus 71 vaccinevaccine safetyadverse events following immunizationpost-marketing safetyAEFI surveillance
spellingShingle Yiqing Zhu
Yihan Wang
Jinghui Wang
Yafei Wang
Li Sun
Shiheng Cui
Jing Li
Yu Guo
Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative study in China
Human Vaccines & Immunotherapeutics
Enterovirus 71 vaccine
vaccine safety
adverse events following immunization
post-marketing safety
AEFI surveillance
title Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative study in China
title_full Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative study in China
title_fullStr Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative study in China
title_full_unstemmed Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative study in China
title_short Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative study in China
title_sort adverse events following immunization surveillance on two types of enterovirus 71 vaccines a real world comparative study in china
topic Enterovirus 71 vaccine
vaccine safety
adverse events following immunization
post-marketing safety
AEFI surveillance
url https://www.tandfonline.com/doi/10.1080/21645515.2025.2458831
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