Thrombotic adverse events reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 vaccines: comparison of occurrence and clinical outcomes in the EudraVigilance database.

Tobaiqy, Mansour; MacLure, Katie; Elkout, Hajer; Stewart, Derek

Abstract

Vaccination against COVID-19 is the cornerstone of controlling and mitigating the ongoing pandemic. Thrombotic adverse events linked to Moderna, Pfizer and the Oxford-AstraZeneca vaccine have been documented and described as extremely rare. While the Oxford-AstraZeneca vaccine has received much of the attention, the other vaccines should not go unchallenged. This study aimed to determine the frequency of reported thrombotic adverse events and clinical outcomes for these three COVID-19 vaccines, namely, Moderna, Pfizer and Oxford-AstraZeneca. A retrospective descriptive analysis was conducted of spontaneous reports for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 vaccines submitted to the EudraVigilance database in the period from 17 February to 14 June 2021. There were 729,496 adverse events for the three vaccines, of which 3420 were thrombotic, mainly Oxford-AstraZeneca (n = 1988; 58.1%) followed by Pfizer (n = 1096; 32.0%) and Moderna (n = 336; 9.8%). As serious adverse events, there were 705 reports of pulmonary embolism for the three vaccines, of which 130 reports (18.4%) were for Moderna, 226 reports (32.1%) for Pfizer and 349 (49.5%) for Oxford-AstraZeneca vaccines. The occurrence of pulmonary embolism is significantly associated with a fatal outcome (p ≤ 0.001). Sixty-three fatalities were recorded (n = 63/3420; 1.8%), of which Moderna (n = 6), Pfizer (n = 25) and Oxford-AstraZeneca (n = 32).

Citation

TOBAIQY, M., MACLURE, A., ELKOUT, H. and MACLURE, K. 2021. Thrombotic adverse events reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 vaccines: comparison of occurrence and clinical outcomes in the EudraVigilance database. Vaccines [online], 9(11), article 1326. Available from: https://doi.org/10.3390/vaccines9111326

• Journal Article Type: Article
• Acceptance Date: Nov 12, 2021
• Online Publication Date: Nov 15, 2021
• Publication Date: Nov 30, 2021
• Deposit Date: Apr 26, 2022
• Publicly Available Date: Apr 26, 2022
• Journal: Vaccines
• Electronic ISSN: 2076-393X
• Publisher: MDPI
• Peer Reviewed: Peer Reviewed
• Volume: 9
• Issue: 11
• Article Number: 1326
• DOI: https://doi.org/10.3390/vaccines9111326
• Keywords: Adverse events; Adverse drug reaction; Thrombotic; COVID-19 vaccine; Pfizer; Moderna; AstraZenaca; COVID-19
• Public URL: https://rgu-repository.worktribe.com/output/1580503