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COVID-19 vaccine-associated cerebral venous thrombosis in Germany: a descriptive study
Joerg B. Schulz; Peter Berlit; Hans-Christoph Diener; Christian Gerloff; Andreas Greinacher; Christine Klein; Gabor C. Petzold; Marco Piccininni; Sven Poli; Rainer Roehrig; Helmuth Steinmetz; Thomas Thiele; Tobias Kurth.
Affiliation
  • Joerg B. Schulz; RWTH Aachen University
  • Peter Berlit; German Society of Neurology
  • Hans-Christoph Diener; Medical Faculty of the University Duisburg-Essen
  • Christian Gerloff; University Hospital Hamburg-Eppendorf
  • Andreas Greinacher; Universitaetsmedizin Greifswald
  • Christine Klein; University of Luebeck
  • Gabor C. Petzold; University Hospital Bonn
  • Marco Piccininni; Charite - Universitaetsmedizin Berlin
  • Sven Poli; University of Tuebingen
  • Rainer Roehrig; RWTH Aachen University
  • Helmuth Steinmetz; University Hospital Frankfurt
  • Thomas Thiele; Universitaetsmedizin Greifswald
  • Tobias Kurth; Charite - Universitaetsmedizin Berlin
Preprint in English | medRxiv | ID: ppmedrxiv-21256383
ABSTRACT
ObjectiveReports of cerebral sinus and venous thrombosis (CVT) after ChAdOx1 vaccination against SARS-CoV-2 have raised safety concerns. We aimed to estimate the incidence of CVT within one 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. MethodsA web-based questionnaire was e-mailed to all Departments of Neurology. We asked to report cases of CVT within one month of a COVID-19 vaccination. Other cerebral events could also be reported. Incidence rates of CVT were calculated by using official statistics of nine German States. ResultsA 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 below the age of 60 years. Fifty-three events were observed after vaccination with ChAdOx1 (85.5%), 9 after BNT162b2 (14.5%), and none after mRNA-1273 vaccination. After 7,126,434 first vaccine doses, the incidence rate of CVT within one month from first dose administration was 6.5 (95% CI, 4.4-9.2) per 100,000 person-years for all vaccines and 17.9 (11.8-26.1) for ChAdOx1 (after 2,320,535 ChAdOx1 first doses). The adjusted incidence rate ratio was 9.68 (3.46-34.98) for ChAdOx1 compared to mRNA-based vaccines and 3.14 (1.22-10.65) for women compared to non-women. In 26/45 patients with CVT (57.8%), VITT was graded highly probable. ConclusionsGiven an incidence of 0.22-1.75 per 100,000 person-years for CVT in the general population, these findings point towards a higher risk for CVT after ChAdOx1 vaccination, especially for women.
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Full text: Available Collection: Preprints Database: medRxiv Type of study: Observational study / Prognostic study Language: English Year: 2021 Document type: Preprint
Full text: Available Collection: Preprints Database: medRxiv Type of study: Observational study / Prognostic study Language: English Year: 2021 Document type: Preprint
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