Thrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of Occurrence and Clinical Outcomes in the EudraVigilance Database
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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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SciScore for 10.1101/2021.09.12.21263462: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources The reports identified were then exported to Microsoft Excel files and classified according to the following variables: age (age groups: ≥85 years old, 65-84 and 18-64 years old), sex, month of reporting, origin of the report, reporter’s profession (healthcare professional or non-healthcare professional) and concomitant conditions. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)All analyses were performed using SPSS for Windows 20·0 (SPSS, Chicago, Illinois, USA). SPSSsuggested: (SPSS, RRID:SCR_0…SciScore for 10.1101/2021.09.12.21263462: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources The reports identified were then exported to Microsoft Excel files and classified according to the following variables: age (age groups: ≥85 years old, 65-84 and 18-64 years old), sex, month of reporting, origin of the report, reporter’s profession (healthcare professional or non-healthcare professional) and concomitant conditions. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)All analyses were performed using SPSS for Windows 20·0 (SPSS, Chicago, Illinois, USA). SPSSsuggested: (SPSS, RRID:SCR_002865)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:The limitations of this study, as with spontaneous reporting schemes of adverse reactions of both drugs and vaccines, is hampered by underreporting, over reporting and reporting bias. This makes it difficult to identify the true incidence of these events and the presence of multiple confounders which may not enable the assessment of the causality with higher specificity.22 In addition, due to the nature of the database, it was not possible to know the denominator (the total number of vaccinated individuals for each type of vaccine), which hinders the analysis of likelihood of true occurrence of thrombotic adverse events for each vaccine. Also, we were unable to report possible concomitant drugs. Despite these limitations, the study used global “real-world” data and collected valuable information about three widely used vaccines, where more than two thirds of all reports were received from healthcare professionals which increases the credibility and quality of reports. People who are vaccine hesitant and reluctant to take any of the mentioned vaccines,23 should know that most COVID-19 vaccines are effective to prevent symptomatic infection including hospital admissions and severe disease.24,25 The risk of COVID-19 related thrombotic events are minimal and likely manageable with available treatments.8 Thrombotic adverse events reported for the three vaccines remains extremely rare.8,26 In summary, thrombotic adverse events reported for the three vaccines remains extremely rare ...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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