Analysis of post-marketing safety monitoring of split influenza virus vaccine based on large samples
- VernacularTitle:基于大样本流感病毒裂解疫苗上市后安全性检测分析
- Author:
Peng DENG
1
;
Qiong LI
1
;
Xiaoai QIAN
1
;
Xue GUO
2
;
Haiping CHEN
3
;
Xiaoqin LIU
3
;
Xuanwen SHI
1
;
Wei JIANG
2
;
Jianjun YE
1
;
Faixian ZHAN
1
;
Beifang YANG
1
;
Linyun LUO
3
Author Information
- Publication Type:Journal Article
- Keywords: Split influenza virus vaccine; Post-marketing; Safety; Evaluation
- From: Journal of Public Health and Preventive Medicine 2020;31(3):33-35
- CountryChina
- Language:Chinese
- Abstract: Objective To evaluate the safety of a Chinese thimerosal-free trivalent split influenza virus vaccine after being marketed in a large population. Methods Through the information management system of adverse event following immunization (AEFI), the adverse events in healthy people aged 6 months and above who were vaccinated with split influenza virus vaccine in Hubei Province from October to December 2015 were collected. The data was analyzed by descriptive methodology. Results From October 1, 2015 to June 30, 2016, among the 227 920 people in Hubei Province who were vaccinated with split influenza virus vaccine, the common adverse reactions were mainly fever, redness, irritability, pain and itching. Four cases of AEFI were passively observed and reported in the system, with a reporting rate of 1.76/100 000, among which 3 cases were anaphylactic rash and 1 case was optic neuritis. Conclusion The Chinese thimerosal-free trivalent split influenza virus vaccine used in Hubei Province had a good safety record and is suitable for the general vaccination of people without vaccination contraindications.
