Thrombotic Events after COVID-19 Vaccination in the Over-50s: Results from a Population-Based Study in Italy

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 yea...

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Main Authors: Ileana Baldi, Danila Azzolina, Andrea Francavilla, Patrizia Bartolotta, Giulia Lorenzoni, Diego Vanuzzo, Dario Gregori
Format: Article
Language:English
Published: MDPI AG 2021-11-01
Series:Vaccines
Subjects:
Online Access:https://www.mdpi.com/2076-393X/9/11/1307
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author Ileana Baldi
Danila Azzolina
Andrea Francavilla
Patrizia Bartolotta
Giulia Lorenzoni
Diego Vanuzzo
Dario Gregori
author_facet Ileana Baldi
Danila Azzolina
Andrea Francavilla
Patrizia Bartolotta
Giulia Lorenzoni
Diego Vanuzzo
Dario Gregori
author_sort Ileana Baldi
collection DOAJ
description 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.
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spelling doaj.art-c14df2f6ff054b3c9cbd83ad24e09c6d2023-11-23T01:52:47ZengMDPI AGVaccines2076-393X2021-11-01911130710.3390/vaccines9111307Thrombotic Events after COVID-19 Vaccination in the Over-50s: Results from a Population-Based Study in ItalyIleana Baldi0Danila Azzolina1Andrea Francavilla2Patrizia Bartolotta3Giulia Lorenzoni4Diego Vanuzzo5Dario Gregori6Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova, 35121 Padova, ItalyDepartment of Medical Science, University of Ferrara, 44100 Ferrara, ItalyUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova, 35121 Padova, ItalyUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova, 35121 Padova, ItalyUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova, 35121 Padova, ItalyCardiovascular Prevention Centre, 33100 Udine, ItalyUnit of Biostatistics, Epidemiology and Public Health, Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova, 35121 Padova, ItalySeveral 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.https://www.mdpi.com/2076-393X/9/11/1307claims dataCOVID-19Vaxzevriasafetyadverse eventsItaly
spellingShingle Ileana Baldi
Danila Azzolina
Andrea Francavilla
Patrizia Bartolotta
Giulia Lorenzoni
Diego Vanuzzo
Dario Gregori
Thrombotic Events after COVID-19 Vaccination in the Over-50s: Results from a Population-Based Study in Italy
Vaccines
claims data
COVID-19
Vaxzevria
safety
adverse events
Italy
title Thrombotic Events after COVID-19 Vaccination in the Over-50s: Results from a Population-Based Study in Italy
title_full Thrombotic Events after COVID-19 Vaccination in the Over-50s: Results from a Population-Based Study in Italy
title_fullStr Thrombotic Events after COVID-19 Vaccination in the Over-50s: Results from a Population-Based Study in Italy
title_full_unstemmed Thrombotic Events after COVID-19 Vaccination in the Over-50s: Results from a Population-Based Study in Italy
title_short Thrombotic Events after COVID-19 Vaccination in the Over-50s: Results from a Population-Based Study in Italy
title_sort thrombotic events after covid 19 vaccination in the over 50s results from a population based study in italy
topic claims data
COVID-19
Vaxzevria
safety
adverse events
Italy
url https://www.mdpi.com/2076-393X/9/11/1307
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