基于VAERS数据库的三类美国上市新型冠状病毒疫苗不良事件分析

doi:10.19803/j.1672-8629.20230100

摘要/Abstract

摘要： 目的根据美国疫苗不良事件报告系统（VAERS）数据,分析和比较由Pfizer、Moderna和Janssen研发的三类紧急上市新型冠状病毒疫苗接种相关的不良事件。方法自三类疫苗获批上市之日起至2022年6月30日,从数据库中检索下载三类疫苗相关不良事件数据,基于组合生物医学统计学方法挖掘筛选有统计意义的不良事件,在此基础上采用不良事件本体制定不良事件图谱。此外,通过提取死亡案例详细信息,对可能影响死亡发生的接种过程变量进行统计分析。结果共计得到81种有统计学意义的不良事件,其中Pfizer相关的67种,Moderna相关的9种,Janssen相关的11种,主要涉及接种者的心血管系统以及行为和神经学病变;死亡案例统计分析显示接种者年龄、性别、疾病史等对死亡发生有一定的特异性影响。结论紧急上市的三类新型冠状病毒疫苗是相对安全的,接种后发生的不良事件大多是轻微的、自限性的。对于特定不良事件（尤其是严重不良事件）与疫苗接种间的确切关系和死亡案例的汇总分析值得在未来的研究中给予更为深入的探讨。

关键词: 新型冠状病毒, 疫苗, 不良事件, 疫苗不良事件报告系统, Pfizer, Moderna, Janssen

Abstract: Objective To analyze and compare adverse events (AE) associated with three emergency licensed COVID-19 vaccines (i.e., Pfizer, Moderna, and Janssen) based on data from the Vaccine Adverse Event Reporting System (VAERS). Methods Data on AE associated with Pfizer, Moderna, and Janssen collected from the days the three vaccines were approved until June 30, 2022 was retrieved from VAERS database respectively. The combinatorial biomedical statistical methods were used to identify statistically significant AE. The profiles of AE were classified and represented by the Ontology of Adverse Events (OAE) for further analysis. In addition, statistical analysis based on detailed information in case reports of death was conducted to identify the major variables that might affect the occurrence of death. Results Eighty-one statistically significant AE were identified, including 67 related to Pfizer, 9 related to Moderna, and 11 related to Janssen. These AE mostly involved the cardiovascular system and behavioral and neurological conditions. Statistical analysis of case reports of death showed that the age, gender, and medical history of the vaccinated individuals had some specific effects on the occurrence of death. Conclusion The three COVID-19 vaccines have a wide safety profile with only minor and self-limiting AE. The causal association between COVID-19 vaccines and consequent AE (especially serious AE) deserves more study.

Key words: COVID-19, vaccine, adverse event, vaccine adverse event reporting system, Pfizer, Moderna, Janssen

中图分类号:

R978
R994.11

杨秋月, 苏俊, 张雪, 谢江安. 基于VAERS数据库的三类美国上市新型冠状病毒疫苗不良事件分析[J]. 中国药物警戒, 2023, 20(10): 1141-1147.

YANG Qiuyue, SU Jun, ZHANG Xue, XIE Jiangan. Adverse events associated with the three US licensed COVID-19 vaccines based on VAERS database[J]. Chinese Journal of Pharmacovigilance, 2023, 20(10): 1141-1147.

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