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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.
Li, Xintong; Burn, Edward; Duarte-Salles, Talita; Yin, Can; Reich, Christian; Delmestri, Antonella; Verhamme, Katia; Rijnbeek, Peter; Suchard, Marc A; Li, Kelly; Mosseveld, Mees; John, Luis H; Mayer, Miguel-Angel; Ramirez-Anguita, Juan-Manuel; Cohet, Catherine; Strauss, Victoria; Prieto-Alhambra, Daniel.
  • Li X; Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
  • Burn E; Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK Edward.burn@ndorms.ox.ac.uk.
  • Duarte-Salles T; Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
  • Yin C; Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
  • Reich C; Real World Solutions, IQVIA, Durham, NC, USA.
  • Delmestri A; Real World Solutions, IQVIA, Durham, NC, USA.
  • Verhamme K; Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
  • Rijnbeek P; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands.
  • Suchard MA; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands.
  • Li K; Department of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, Los Angeles, CA, USA.
  • Mosseveld M; Department of Human Genetics, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, CA, USA.
  • John LH; Department of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, Los Angeles, CA, USA.
  • Mayer MA; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands.
  • Ramirez-Anguita JM; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands.
  • Cohet C; Research Programme on Biomedical Informatics, Hospital del Mar Medical Research Institute, Faculty of Health and Life Sciences, University of Pompeu Fabra, Barcelona, Spain.
  • Strauss V; Research Programme on Biomedical Informatics, Hospital del Mar Medical Research Institute, Faculty of Health and Life Sciences, University of Pompeu Fabra, Barcelona, Spain.
  • Prieto-Alhambra D; Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, Netherlands.
BMJ ; 379: e071594, 2022 10 26.
Article in English | MEDLINE | ID: covidwho-2088782
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Thrombocytopenia / Thromboembolism / Thrombosis / COVID-19 Vaccines Type of study: Cohort study / Observational study / Prognostic study / Randomized controlled trials / Reviews Topics: Vaccines Limits: Adolescent / Adult / Humans Language: English Journal: BMJ Journal subject: Medicine Year: 2022 Document Type: Article Affiliation country: Bmj-2022-071594

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thrombocytopenia / Thromboembolism / Thrombosis / COVID-19 Vaccines Type of study: Cohort study / Observational study / Prognostic study / Randomized controlled trials / Reviews Topics: Vaccines Limits: Adolescent / Adult / Humans Language: English Journal: BMJ Journal subject: Medicine Year: 2022 Document Type: Article Affiliation country: Bmj-2022-071594