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Analysis of thrombotic adverse reactions of COVID-19 AstraZeneca vaccine reported to EudraVigilance database.

Tobaiqy, Mansour; Elkout, Hajer; MacLure, Katie

Authors

Mansour Tobaiqy

Hajer Elkout

Katie MacLure



Abstract

The development of safe, effective, affordable vaccines against COVID-19 remains the cornerstone to mitigating this pandemic. Early in December 2020, multiple research groups had designed potential vaccines. From 11 March 2021, several European countries temporarily suspended the use of the Oxford–AstraZeneca vaccine amid reports of blood clot events and the death of a vaccinated person, despite the European Medicines Agency (EMA) and the World Health Organization's assurance that there was no indication that vaccination was linked. This study aimed to identify and analyse the thrombotic adverse reactions associated with the Oxford–AstraZeneca vaccine. This was a retrospective descriptive study using spontaneous reports submitted to the EudraVigilance database in the period from 17 February to 12 March 2021. There were 54,571 adverse reaction reports, of which 28 were associated with thrombotic adverse reactions. Three fatalities were related to pulmonary embolism; one fatality to thrombosis. With 17 million people having had the AstraZeneca vaccine, these are extremely rare events The EMA's Pharmacovigilance Risk Assessment Committee (18 March 2021) concluded that the vaccine was safe, effective and the benefits outweighed the risks. Conducting further analyses based on more detailed thrombotic adverse event reports, including patients' characteristics and comorbidities, may enable assessment of the causality with higher specificity.

Citation

TOBAIQY, M., ELKOUT, H. and MACLURE, K. 2021. Analysis of thrombotic adverse reactions of COVID-19 AstraZeneca vaccine reported to EudraVigilance database. Vaccines [online], 9(4), article 393. Available from: https://doi.org/10.3390/vaccines9040393

Journal Article Type Article
Acceptance Date Apr 13, 2021
Online Publication Date Apr 16, 2021
Publication Date Apr 30, 2021
Deposit Date Apr 29, 2022
Publicly Available Date Apr 29, 2022
Journal Vaccines
Electronic ISSN 2076-393X
Publisher MDPI
Peer Reviewed Peer Reviewed
Volume 9
Issue 4
Article Number 393
DOI https://doi.org/10.3390/vaccines9040393
Keywords COVID-19; Adverse events; Adverse drug reaction; Thrombotic; Vaccine
Public URL https://rgu-repository.worktribe.com/output/1318738

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