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Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative
Yiqing Zhu1, Yihan Wang1, Jinghui Wang1
1Department of Immunization Management, Hebei Province Center for Disease Prevention and Control, Shijiazhuang, Hebei Province, China.
Insights
Two types of Enterovirus 71 (EV71) vaccines, EV71-Vero and EV71-H2, show good safety profiles. Adverse events following immunization (AEFI) were similar, though age-related differences in AEFI were noted.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Enterovirus 71 (EV71) infection poses a significant threat to children's health.
- Two distinct EV71 vaccines, EV71-Vero (Vero cells) and EV71-H2 (human diploid cells), are available.
- Comprehensive safety data is crucial for vaccine recommendation and public health policy.
Purpose of the Study:
- To compare the safety and adverse events following immunization (AEFI) of EV71-Vero and EV71-H2 vaccines.
- To analyze AEFI rates and characteristics across different age groups in children vaccinated in Hebei Province.
- To provide evidence-based recommendations for EV71 vaccine use.
Main Methods:
- Retrospective analysis of AEFI data from children vaccinated with EV71-Vero or EV71-H2 from 2019-2023.
- Comparison of AEFI incidence rates and types between the two vaccine groups.
- Statistical analysis to identify significant differences in AEFI across demographic variables, particularly age.
Main Results:
- A total of 477 AEFI were reported, with an overall rate of 14.21 per 100,000 doses.
- Most AEFI occurred in infants under one year of age (45.91%).
- No significant overall difference in AEFI rates between EV71-Vero and EV71-H2 vaccines, but age-specific variations were observed, particularly in children under one year and those aged 4-5 years.
Conclusions:
- Both EV71-Vero and EV71-H2 vaccines demonstrate good safety profiles.
- While overall AEFI rates are comparable, age-specific monitoring and analysis are important.
- EV71 vaccination is recommended for appropriate age groups to prevent EV71 infection.
Abstract:
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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