Baldi Ileana, Azzolina Danila, Francavilla Andrea, Bartolotta Patrizia, Lorenzoni Giulia, Vanuzzo Diego, Gregori Dario
Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova, 35121 Padova, Italy.
Department of Medical Science, University of Ferrara, 44100 Ferrara, Italy.
Vaccines (Basel). 2021 Nov 10;9(11):1307. doi: 10.3390/vaccines9111307.
Several European countries suspended or changed recommendations for the use of Vaxzevria (AstraZeneca) for suspected adverse effects due to atypical blood-clotting. This research aims to identify a reference point towards the number of thrombotic events expected in the Italian population over 50 years of age who received Vaxzevria from 22 January to 12 April 2021. The venous thromboembolism (VT) and immune thrombocytopenia (ITP) event rates were estimated from a population-based cohort. The overall VT rate was 1.15 (95% CI 0.93-1.42) per 1000 person-years, and the ITP rate was 2.7 (95% CI 0.7-11) per 100,000 person-years. These figures translate into 83 and two expected events of VT and ITP, respectively, in the 15 days following the first administration of Vaxzevria. The number of thrombotic events reported from the Italian Medicines Agency does not appear to have increased beyond that expected in individuals over 50 years of age.
由于非典型凝血的疑似不良反应，几个欧洲国家暂停或更改了关于使用Vaxzevria（阿斯利康）疫苗的建议。本研究旨在确定一个参考点，以了解在2021年1月22日至4月12日期间接种Vaxzevria疫苗的意大利50岁以上人群中预期的血栓形成事件数量。静脉血栓栓塞（VT）和免疫性血小板减少症（ITP）的事件发生率是根据一个基于人群的队列估算得出的。总体VT发生率为每1000人年1.15（95%置信区间0.93 - 1.42），ITP发生率为每100,000人年2.7（95%置信区间0.7 - 11）。这些数字分别转化为首次接种Vaxzevria疫苗后15天内预计发生83例VT事件和2例ITP事件。意大利药品管理局报告的血栓形成事件数量似乎并未超过50岁以上人群的预期数量。
