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Comparative risk of thrombosis with thrombocytopenia syndrome or thromboembolic events associated with different covid-19 vaccines: international network cohort study from five European countries and the US

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dc.contributor.author Li, Xintong
dc.contributor.author Burn, Edward
dc.contributor.author Duarte Salles, Talita, 1985-
dc.contributor.author Yin, Can
dc.contributor.author Reich, Christian
dc.contributor.author Delmestri, Antonella
dc.contributor.author Verhamme, Katia M. C.
dc.contributor.author Rijnbeek, Peter
dc.contributor.author Suchard, Marc A.
dc.contributor.author Li, Kelly
dc.contributor.author Mosseveld, Mees
dc.contributor.author John, Luis H.
dc.contributor.author Mayer, Miguel Ángel, 1960-
dc.contributor.author Ramírez Anguita, Juan Manuel
dc.contributor.author Cohet, Catherine
dc.contributor.author Strauss, Victoria Y.
dc.contributor.author Prieto-Alhambra, Daniel
dc.date.accessioned 2024-04-26T06:33:50Z
dc.date.available 2024-04-26T06:33:50Z
dc.date.issued 2022
dc.identifier.citation Li X, Burn E, Duarte-Salles T, Yin C, Reich C, Delmestri A, et al. Comparative risk of thrombosis with thrombocytopenia syndrome or thromboembolic events associated with different covid-19 vaccines: international network cohort study from five European countries and the US. BMJ. 2022;379(8358):e071594. DOI: 10.1136/bmj-2022-071594
dc.identifier.issn 1759-2151
dc.identifier.uri http://hdl.handle.net/10230/59913
dc.description.abstract Objective: To quantify the comparative risk of thrombosis with thrombocytopenia syndrome or thromboembolic events associated with use of adenovirus based covid-19 vaccines versus mRNA based covid-19 vaccines. Design: International network cohort study. Setting: Routinely collected health data from contributing datasets in France, Germany, the Netherlands, Spain, the UK, and the US. Participants: Adults (age ≥18 years) registered at any contributing database and who received at least one dose of a covid-19 vaccine (ChAdOx1-S (Oxford-AstraZeneca), BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), or Ad26.COV2.S (Janssen/Johnson & Johnson)), from December 2020 to mid-2021. Main outcome measures: Thrombosis with thrombocytopenia syndrome or venous or arterial thromboembolic events within the 28 days after covid-19 vaccination. Incidence rate ratios were estimated after propensity scores matching and were calibrated using negative control outcomes. Estimates specific to the database were pooled by use of random effects meta-analyses. Results: Overall, 1 332 719 of 3 829 822 first dose ChAdOx1-S recipients were matched to 2 124 339 of 2 149 679 BNT162b2 recipients from Germany and the UK. Additionally, 762 517 of 772 678 people receiving Ad26.COV2.S were matched to 2 851 976 of 7 606 693 receiving BNT162b2 in Germany, Spain, and the US. All 628 164 Ad26.COV2.S recipients from the US were matched to 2 230 157 of 3 923 371 mRNA-1273 recipients. A total of 862 thrombocytopenia events were observed in the matched first dose ChAdOx1-S recipients from Germany and the UK, and 520 events after a first dose of BNT162b2. Comparing ChAdOx1-S with a first dose of BNT162b2 revealed an increased risk of thrombocytopenia (pooled calibrated incidence rate ratio 1.33 (95% confidence interval 1.18 to 1.50) and calibrated incidence rate difference of 1.18 (0.57 to 1.8) per 1000 person years). Additionally, a pooled calibrated incidence rate ratio of 2.26 (0.93 to 5.52) for venous thrombosis with thrombocytopenia syndrome was seen with Ad26.COV2.S compared with BNT162b2. Conclusions: In this multinational study, a pooled 30% increased risk of thrombocytopenia after a first dose of the ChAdOx1-S vaccine was observed, as was a trend towards an increased risk of venous thrombosis with thrombocytopenia syndrome after Ad26.COV2.S compared with BNT162b2. Although rare, the observed risks after adenovirus based vaccines should be considered when planning further immunisation campaigns and future vaccine development.
dc.format.mimetype application/pdf
dc.language.iso eng
dc.publisher BMJ Publishing Group
dc.relation.ispartof BMJ. 2022;379(8358):e071594
dc.rights This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.
dc.rights.uri http://creativecommons.org/licenses/by/4.0/
dc.subject.other Trombosi
dc.subject.other COVID-19 (Malaltia)
dc.subject.other Vacunes
dc.title Comparative risk of thrombosis with thrombocytopenia syndrome or thromboembolic events associated with different covid-19 vaccines: international network cohort study from five European countries and the US
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.1136/bmj-2022-071594
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/publishedVersion

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