COVID‐19 Vaccine‐Associated Cerebral Venous Thrombosis in Germany

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

Cerebral Venous Sinus Thrombosis After BNT162b2 mRNA COVID-19 Vaccination

“…This is consistent with the recent report from the European Medicines Agency, in which 213 postvaccination CVST patients (ChAdOx1 nCoV-19 n = 187; BNT162b2 mRNA n = 25; mRNA-1273 n =1) were identified in their database, and thrombocytopenia was not recognized in the mRNA-based vaccine group [17]. The absence of a relationship between mRNA-based vaccines and thrombocytopenia was also consistent with research from Germany [16], England [14], and Scotland [15]. The pathophysiological mechanism leading to CVST after mRNA-based vaccination remains unclear.…”

Delayed headache after COVID-19 vaccination: a red flag for vaccine induced cerebral venous thrombosis

“…Several cases of cerebral venous thrombosis (CVT) have been reported in non-replicant adenovirus vectorbased COVID-19 vaccine recipients (Oxford-AstraZeneca ChAdOx1-S and Johnson & Johnson (J&J) Janssen Ad26.COV2S) [3][4][5][6][7]. The association was based on the presence of thrombocytopenia [3][4][5][6][7][8], anti-platelet factor 4 antibodies [6,7], and multiple organ thrombosis (vaccine-induced immune thrombotic thrombocytopenia (VITT)) [3][4][5][6][7][8]. There was a higher mortality rate [3][4][5][6][7][8] than in other CVT series reported in the literature and an increased standardized morbidity ratio (SMR) in patients aged between 30 and 49 [3].…”

“…The association was based on the presence of thrombocytopenia [3][4][5][6][7][8], anti-platelet factor 4 antibodies [6,7], and multiple organ thrombosis (vaccine-induced immune thrombotic thrombocytopenia (VITT)) [3][4][5][6][7][8]. There was a higher mortality rate [3][4][5][6][7][8] than in other CVT series reported in the literature and an increased standardized morbidity ratio (SMR) in patients aged between 30 and 49 [3]. SMR is also known as observed-to-expected analysis, which analyses the ratio between the observed number of cases in the population over the number of cases that would be expected based on the baseline incidence according to databases and prior studies [9,10].…”

Case report: cerebral sinus vein thrombosis in two patients with AstraZeneca SARS-CoV-2 vaccination

“…The risk of thrombosis (just) in combination with thrombocytopenia (thrombosis with thrombocytopenia syndrome) is reported by the EMA to be up to 1 in 10,000 people [11]. Meanwhile, cases of CSVT also exist after vaccination with mRNA vaccines such as BNT162b2 [12].…”