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辉瑞/生物科技或莫德纳 COVID-19 疫苗接种的年轻女性中的血栓栓塞事件。

Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines.

机构信息

Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.

Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.

出版信息

Expert Opin Drug Saf. 2021 Nov;20(11):1451-1453. doi: 10.1080/14740338.2021.1955101. Epub 2021 Jul 26.

Abstract

: Concerns about the increased risk of blood clots associated with the VAXZEVRIA (previously named Oxford-AstraZeneca COVID-19 vaccine) and Johnson & Johnson (Janssen) COVID-19 vaccines raises the question of the thrombotic safety of other COVID-19 vaccines such as Pfizer-BioNTech or Moderna, especially in younger women, who at the early stage of the pandemic was a priority group for vaccination. : Using the US-based Vaccine Adverse Event Reporting System (VAERS) and the FDA Event Reporting System (FAERS), we retrieved cases of thrombosis following vaccinations or hormonal contraceptive use in women aged ≤ 50 years. We used the reporting odds ratio (ROR) as a disproportionality measure. : On 19 March 2021, out of 13.6 million women aged ≤ 50 exposed to at least one dose of Pfizer-BioNTech or Moderna COVID-19 vaccines in the US, only 61 cases were reported with a total of 68 thromboembolic events (1 case per 222,951 vaccinated). None of the thromboembolic events included in our analysis were disproportionally reported for the two COVID-19 vaccines. Our results do support that, when compared to hormonal contraceptive use, the mRNA vaccines do not show disproportional reporting of thromboembolic events in younger women.

摘要

: 人们对 VAXZEVRIA(原名牛津-阿斯利康 COVID-19 疫苗)和强生(Janssen)COVID-19 疫苗血栓形成风险增加的担忧引发了对其他 COVID-19 疫苗(如辉瑞-生物科技或 Moderna)的血栓形成安全性的质疑,尤其是在年轻女性中,她们在大流行早期是接种疫苗的优先群体。 : 我们使用了基于美国的疫苗不良事件报告系统(VAERS)和 FDA 事件报告系统(FAERS),检索了≤50 岁女性接种疫苗或使用激素避孕药后发生血栓的病例。我们使用报告比值比(ROR)作为一种不均匀性测量。 : 截至 2021 年 3 月 19 日,在美国至少接种了一剂辉瑞-生物科技或 Moderna COVID-19 疫苗的≤50 岁的 1360 万女性中,仅报告了 61 例,总计 68 例血栓栓塞事件(每 222951 名接种疫苗者中有 1 例)。我们分析中包含的血栓栓塞事件均未被报告为两种 COVID-19 疫苗的不均匀性报告。我们的结果确实支持这样的观点,与激素避孕药相比,mRNA 疫苗在年轻女性中未显示出血栓栓塞事件的不成比例报告。

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