摘要
目的:基于美国疫苗不良事件报告系统(Vaccine Adverse Event Reporting System,VAERS)数据,比较信使核糖核酸(messenger RNA,mRNA)、腺病毒载体两类COVID-19新冠疫苗引起静脉血栓栓塞(venous thromboembolism,VTE)不良事件的风险信号.方法:提取2020年1月至2023年6月VAERS数据库新冠疫苗相关不良反应(adverse drug reaction,ADR)数据,统计分析mRNA疫苗和腺病毒载体疫苗VTE不良反应的人口学特征;通过比例失衡法,利用报告比值比(reporting odds ratio,ROR)和Fisher's精确检验检测比较两类新冠疫苗的VTE风险信号;使用Weibull分布分析两类新冠疫苗与VTE发病间隔的关系.结果:共检索到COVID-19疫苗VTE不良反应7 764例,其中mRNA疫苗6 445例,61～80岁人群发生VTE占比较高,以第2剂接种后发生VTE为主(2 684例,41.64％);腺病毒载体疫苗1 319例,VTE发生以第1剂接种后为主(843例,63.91％).与其他疫苗相比,比例失衡法检测到两类新冠疫苗具有VTE风险信号,ROR分别为mRNA疫苗10.91(95％CI:8.07～14.76)和腺病毒载体疫苗29.63(95％CI:21.83～40.22).同时,腺病毒载体疫苗与mRNA疫苗总VTE的ROR为2.71(95％CI:2.56～2.88),并检测到8个腺病毒载体疫苗VTE风险信号.Weibull分布结果显示3剂mRNA疫苗VTE距离接种的发生时间分别为9(3～23)d、23(5～83)d和25(6～107)d,2剂腺病毒载体疫苗VTE距离接种发生时间分别为17(8～46)d和16(5～182)d.结论:接种COVID-19新冠疫苗存在VTE风险,两类疫苗VTE均趋向于接种后早期出现.与mRNA疫苗相比,腺病毒载体疫苗存在较强的VTE风险信号,预防接种新冠疫苗时应注意监测VTE的发生.
Abstract
OBJECTIVE To explore the trends in reporting venous thromboembolism(VTE)for two types of COVID-19 vaccinations based upon the data of Vaccine Adverse Event Reporting System(VAERS).METHODS Raw data on COVID-19 vaccines associated with adverse drug reactions(ADR)were retrieved from the database of VAERS from January 2020 to June 2023.Demographic profiles of messenger RNA(mRNA)vaccine and adenovirus vector-based vaccine associated with、VTE were statistically examined.ADR signals of two types of vaccines were detected by reporting odds ratio(ROR)and Fisher's exact test and plotted on a volcano graph.Weibull distribution was utilized for time-to-onset analysis.RESULTS A total of 7 764 cases of COVID-19 vaccines associated with VTE were retrieved,including mRNA vaccine(n=6 445).A higher percentage of VTE occurred in 61-80-year-old subjects mostly after a second dose of vaccination(n=2 684,41.64％).Among 1 319 cases of adeno-virus vector-based vaccine,VTE primarily occurred after an initial dose of immunization(n=843,63.91％).As compared with other vaccines,two types of COVID-19 vaccines carried the risk signals of VTE by proportional imbalance method with a ROR of 10.91(95％CI:8.07-14.76)for mRNA vaccine and 29.63(95％CI:21.83-40.22)for adenovirus vector-based vaccine.ROR for total VTE of adenovirus vector-based vaccine versus mRNA vaccine was 2.71(95％CI:2.56-2.88)and 8 risk signals of VTE were detected for adenovirus vector-based vaccine.Weibull distribution results indicated that VTE occurred at Day 9(3-23),23(5-83)and 25(6-107)post-vaccination for 3 doses of mRNA vaccine and Day 17(8-46)and 16(5-182)post-vaccination for 2 doses of adenovirus vector-based vaccine.CONCLUSION There is a risk of VTE associated with COVID-19 vaccination.And VTE is prone to occur during early post-vaccination period for both vaccines.As compared with mRNA vac-cine,adenovirus-vectored vaccine has a stronger risk signal of VTE and VTE should be monitored during preventive COVID-19 vaccination.
基金项目
国家卫生健康委医院管理研究所医院药学高质量发展研究项目(NIHAYS2302)
NETL
NSTL
万方数据