<scp>COVID</scp>‐19 Vaccine‐Associated Cerebral Venous Thrombosis in Germany

  • Jörg B. Schulz
    Department of Neurology Rheinisch‐Westfälische Techische Hochschule (RWTH) Aachen University Aachen Germany
  • Peter Berlit
    German Society of Neurology Berlin Germany
  • Hans‐Christoph Diener
    Institute for Medical Informatics, Biometry and Epidemiology University of Duisburg‐Essen Essen Germany
  • Christian Gerloff
    German Society of Neurology Berlin Germany
  • Andreas Greinacher
    Department of Transfusion Medicine, Institute of Immunology and Transfusion Medicine University Medical Center Greifswald Greifswald Germany
  • Christine Klein
    German Society of Neurology Berlin Germany
  • Gabor C. Petzold
    Section of Vascular Neurology, Department of Neurology University Hospital Bonn Bonn Germany
  • Marco Piccininni
    Institute of Public Health Charité – Universitätsmedizin Berlin Berlin Germany
  • Sven Poli
    Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research University of Tübingen Tübingen Germany
  • Rainer Röhrig
    Institute of Medical Informatics RWTH Aachen University Aachen Germany
  • Helmuth Steinmetz
    Department of Neurology University Hospital Frankfurt Frankfurt Germany
  • Thomas Thiele
    Department of Transfusion Medicine, Institute of Immunology and Transfusion Medicine University Medical Center Greifswald Greifswald Germany
  • Tobias Kurth
    Institute of Public Health Charité – Universitätsmedizin Berlin Berlin Germany

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<jats:sec><jats:title>Objective</jats:title><jats:p>We aimed to estimate the incidence of cerebral sinus and venous thrombosis (CVT) within 1 month from first dose administration and the frequency of vaccine‐induced immune thrombotic thrombocytopenia (VITT) as the underlying mechanism after vaccination with BNT162b2, ChAdOx1, and mRNA‐1273, in Germany.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>A web‐based questionnaire was e‐mailed to all departments of neurology. We requested a report of cases of CVT occurring within 1 month of a COVID‐19 vaccination. Other cerebral events could also be reported. Incidence rates of CVT were calculated by using official statistics of 9 German states.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 45 CVT cases were reported. In addition, 9 primary ischemic strokes, 4 primary intracerebral hemorrhages, and 4 other neurological events were recorded. Of the CVT patients, 35 (77.8%) were female, and 36 (80.0%) were younger than 60 years. Fifty‐three events were observed after vaccination with ChAdOx1 (85.5%), 9 after BNT162b2 (14.5%) vaccination, and none after mRNA‐1273 vaccination. After 7,126,434 first vaccine doses, the incidence rate of CVT within 1 month from first dose administration was 0.55 (95% confidence interval [CI] = 0.38–0.78) per 100,000 person‐months (which corresponds to a risk of CVT within the first 31 days of 0.55 per 100,000 individuals) for all vaccines and 1.52 (95% CI = 1.00–2.21) for ChAdOx1 (after 2,320,535 ChAdOx1 first doses). The adjusted incidence rate ratio was 9.68 (95% CI = 3.46–34.98) for ChAdOx1 compared to mRNA‐based vaccines and 3.14 (95% CI = 1.22–10.65) for females compared to non‐females. In 26 of 45 patients with CVT (57.8%), VITT was graded highly probable.</jats:p></jats:sec><jats:sec><jats:title>Interpretation</jats:title><jats:p>Given an incidence of 0.02 to 0.15 per 100,000 person‐months for CVT in the general population, these findings point toward a higher risk for CVT after ChAdOx1 vaccination, especially for women. ANN NEUROL 2021;90:627–639</jats:p></jats:sec>

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