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Thrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of
Mansour Tobaiqy1, Katie MacLure2, Hajer Elkout3
1Department of Pharmacology, College of Medicine, University of Jeddah, Jeddah P.O. Box 45311, Saudi Arabia.
Insights
Thrombotic events are rare but serious adverse events following COVID-19 vaccination. Oxford-AstraZeneca showed the highest frequency of thrombotic events and pulmonary embolism, which is linked to fatal outcomes.
Area of Science:
- Pharmacovigilance
- Epidemiology
- Vaccinology
Background:
- COVID-19 vaccines are crucial for pandemic control.
- Rare thrombotic adverse events have been reported for Moderna, Pfizer, and Oxford-AstraZeneca vaccines.
- Further investigation into comparative frequencies and outcomes is warranted.
Purpose of the Study:
- To determine the frequency of thrombotic adverse events and clinical outcomes.
- To compare these events across Moderna, Pfizer, and Oxford-AstraZeneca COVID-19 vaccines.
Main Methods:
- Retrospective descriptive analysis of spontaneous reports.
- Data sourced from the EudraVigilance database (February 17 to June 14, 2021).
- Analysis focused on thrombotic events, pulmonary embolism, and fatalities.
Main Results:
- 3420 thrombotic events reported out of 729,496 total adverse events.
- Oxford-AstraZeneca had the highest frequency of thrombotic events (58.1%) and pulmonary embolism (49.5%).
- Pulmonary embolism was significantly associated with fatal outcomes (p ≤ 0.001), with 63 recorded fatalities.
Conclusions:
- While rare, thrombotic adverse events, particularly pulmonary embolism, are a serious concern following COVID-19 vaccination.
- Oxford-AstraZeneca vaccine showed a higher reported frequency of these events compared to Moderna and Pfizer.
- Pulmonary embolism following vaccination is linked to increased mortality risk.
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).
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