Germany, 4 May 2021, Schultz et al, Annals of Neurology
We designed web-based questionnaire, which was e-mailed to all Departments of Neurology of University and non-university hospitals in Germany on April 6, 2021. Data collection was closed at midnight on April 14, 2021. We asked to report cases of cerebral sinus-venous thrombosis, cerebral venous thrombosis, ischemic stroke and haemorrhage within one month of a COVID-19 vaccination.
Incidence rates of cerebral events and CVT within one month from first vaccine shot administration was calculated by using official statistics of 9 German States.
Results: A total of 62 cases were detected, of whom 45 had CVT, 9 primary ischemic stroke, 4 primary intracerebral hemorrhage (ICH), and 4 other events. Eleven patients of 60 (18.3%) had a fatal outcome. Mean age was 46.7 years (48 patients <60 years, 77.4%), 75.8% of patients were female. Fifty-three events were observed after vaccination with ChAdOx1 (85.5%), 9 after BNT162b2 (14.5%). No events were reported after mRNA-1273 vaccination. The overall incidence rate of CVT within one month from first dose administration was 6.5 (95% CI, 4.4 to 9.2) per 100,000 person-years and 8.8 (95% CI, 6.4 to 11.9) for any included cerebrovascular event.
The one-month incidence rate of CVT was higher among ChAdOx1 vaccinated persons (17.9, 95% CI, 11.8 to 26.1). The incidence rate ratio was 9.68 (3.46 to 34.98) for ChAdOx1 compared to mRNA-based vaccines and 3.14 (1.22 to 10.65) for women compared to non-women after adjusting for age group. In 26/45 patients with CVT (57.8%), VITT was graded highly probable, in 19/45 patients (42.2%) the association was less likely. A high-grade probability was not confined to CVT but also occurred in 5/9 patients (55.6%) with primary ischemic stroke and 2/4 patients (50%) with ICH following vaccination.
Conclusions: Given an incidence of CVT in the general population of 0.22 – 1.75 per 100,000 person-years, these findings point towards and higher risk for CVT after ChAdOx1 vaccination, especially for women.