• J. Thromb. Haemost. · Oct 2021

    Observational Study

    Comparison of adverse drug reactions among four COVID-19 vaccines in Europe using the EudraVigilance database: Thrombosis at unusual sites.

    • Maria Abbattista, Ida Martinelli, and Flora Peyvandi.
    • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, UOC Medicina Generale, A. Bianchi Bonomi Hemophilia and Thrombosis Center, Milan, Italy.
    • J. Thromb. Haemost. 2021 Oct 1; 19 (10): 2554-2558.

    BackgroundReal-world experience with adenoviral vector vaccines against COVID-19 raised some safety concerns. Cases of cerebral vein thrombosis (CVT) associated with thrombocytopenia have been observed after the first dose of the adenoviral vector vaccines CHADOX1 NCOV-19 and AD26.COV2.S.ObjectivesTo assess the reporting rate of CVT as adverse drug reaction (ADR) for the COVID-19 vaccines authorized in Europe.Patients And MethodsThis observational study assessed the CVT reporting rate attributed to four COVID-19 vaccines authorized in Europe, namely Tozinameran (Pfizer-Biontech), CX-024414 (Moderna), CHADOX1 NCOV-19 (AstraZeneca), and AD26.COV2.S (Janssen). Data on thrombotic ADRs reported on EudraVigilance database between January 1, 2021 and July 30, 2021, were collected. ADRs referring to CVT were identified. The reporting rate of CVT was expressed as 1 million individual vaccinated-days with 95% confidence interval. Finally, an observed-to-expected (OE) analysis was performed.ResultsThe reporting rate of CVT per 1 million person vaccinated-days was 1.92 (95% confidence interval [CI], 1.71-2.12) for Tozinameran, 5.63 (95% CI, 4.74-6.64) for CX-024414, 21.60 (95% CI, 20.16-23.11) for CHADOX1 NCOV-19, and 11.48 (95% CI, 9.57-13.67) for AD26.COV2.S. CVT occurred alongside thrombocytopenia for the four vaccines. The OE ratio was greater than one for all four vaccines, both with the lowest and the highest CVT background incidence.ConclusionsThis report on EudraVigilance data strengthens anecdotal findings on CVT following COVID-19 vaccinations. Although the European Medicines Agency released an alert only for CHADOX1 NCOV-19 and AD26.COV2.S, Tozinameran and CX-024414 also are complicated by CVT, albeit to lesser extent.© 2021 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…