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. 2021 Oct;90(4):627-639.
doi: 10.1002/ana.26172. Epub 2021 Aug 23.

COVID-19 Vaccine-Associated Cerebral Venous Thrombosis in Germany

Jörg B Schulz  1   2 , Peter Berlit  3 , Hans-Christoph Diener  4 , Christian Gerloff  3   5 , Andreas Greinacher  6 , Christine Klein  3   7 , Gabor C Petzold  8   9 , Marco Piccininni  10   11 , Sven Poli  12 , Rainer Röhrig  13 , Helmuth Steinmetz  14 , Thomas Thiele  6 , Tobias Kurth  10 ; German Society of Neurology SARS-CoV-2 Vaccination Study Group
Collaborators, Affiliations

COVID-19 Vaccine-Associated Cerebral Venous Thrombosis in Germany

Jörg B Schulz et al. Ann Neurol. 2021 Oct.

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Interpretation: 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.

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Conflict of interest statement

There was no specific funding for this study. H.‐C.D., S.P., and T.T. report having received personal compensation for contribution to advisory boards and oral presentations from Pfizer and/or AstraZeneca, both manufacturers of SARS‐Cov2 vaccines. A.G. reports holding a pending patent for a modified SARS‐CoV‐2 vaccine. The other authors have nothing to report.

Figures

FIGURE 1
FIGURE 1
Study flow chart.
FIGURE 2
FIGURE 2
Days from first ChAdOx1 dose administration to neurological symptoms onset for cerebral sinus and/or venous thrombosis (CVT) and non‐CVT events.
FIGURE 3
FIGURE 3
Incidence rates with 95% confidence intervals of cerebral sinus and/or venous thrombosis (CVT) within 1 month (31 days) from first dose administration of vaccine against SARS‐CoV‐2 by vaccine type, sex, and age group.
See this image and copyright information in PMC

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