RT Journal Article
SR Electronic
T1 Age-Stratified Risk of Cerebral Venous Sinus Thrombosis After SARS-CoV-2 Vaccination
JF Neurology
JO Neurology
FD Lippincott Williams & Wilkins
SP 10.1212/WNL.0000000000013148
DO 10.1212/WNL.0000000000013148
A1 Krzywicka, Katarzyna
A1 van de Munckhof, Anita
A1 Sánchez van Kammen, Mayte
A1 Heldner, Mirjam R
A1 Jood, Katarina
A1 Lindgren, Erik
A1 Tatlisumak, Turgut
A1 Putaala, Jukka
A1 Kremer Hovinga, Johanna A
A1 Middeldorp, Saskia
A1 Levi, Marcel M
A1 Cordonnier, Charlotte
A1 Arnold, Marcel
A1 Zwinderman, Aeilko H
A1 Ferro, José M
A1 Coutinho, Jonathan M
A1 Aguiar de Sousa, Diana
YR 2021
UL http://n.neurology.org/content/early/2021/12/17/WNL.0000000000013148.abstract
AB Background and Objectives Cerebral Venous Sinus Thrombosis (CVST) as a part of the thrombosis and thrombocytopenia syndrome is a rare adverse drug reaction of SARS-CoV-2 vaccination. Estimated background rate of CVST with thrombocytopenia is 0.1 per million per month. We assessed the age-stratified risk of CVST with and without thrombocytopenia after SARS-CoV-2 vaccination.Methods We estimated the absolute risk of CVST with and without thrombocytopenia within 28 days of first dose of four SARS-CoV-2 vaccinations, using data from the European Medicines Agency’s EudraVigilance database (until 13 June 2021). As a denominator, we used data on vaccine delivery from 31 European countries. For 22.8 million adults from 25 countries, we estimated the absolute risk of CVST after the first dose of ChAdOx1 nCov-19 per age category.Results The absolute risk of CVST within 28 days of first dose vaccination was 7.5 (95%CI 6.9-8.3), 0.7 (95%CI 0.2-2.4), 0.6 (95%CI 0.5-0.7) and 0.6 (95%CI 0.3-1.1) per million of first doses of ChAdOx1 nCov-19, Ad26.COV2.S, BNT162b2 and mRNA-1273, respectively. The absolute risk of CVST with thrombocytopenia within 28 days of first dose vaccination was 4.4 (95%CI 3.9-4.9), 0.7 (95%CI 0.2-2.4), 0.0 (95%CI 0.0-0.1) and 0.0 (95%CI 0.0-0.2) per million of first doses of ChAdOx1 nCov-19, Ad26.COV2.S, BNT162b2 and mRNA-1273, respectively. In recipients of ChAdOx1 nCov-19, the absolute risk of CVST, both with and without thrombocytopenia, was the highest in the 18-24 years age group (7.3 per million, 95%CI 2.8-18.8 and 3.7 per million, 95%CI 1.0-13.3, respectively). The risk of CVST with thrombocytopenia in ChAdOx1 nCov-19 recipients was the lowest in the age group≥70 years (0.2, 95%CI 0.0-1.3). Age <60 compared to ≥60 was a predictor for CVST with thrombocytopenia (incidence rate ratio 5.79; 95%CI 2.98-11.24, p<0.001).Discussion The risk of CVST with thrombocytopenia within 28 days of first dose vaccination with ChAdOx1 nCov-19 was higher in younger age groups. The risk of CVST with thrombocytopenia was slightly increased in patients receiving Ad26.COV2.S, compared with the estimated background risk. The risk of CVST with thrombocytopenia was not increased in recipients of SARS-CoV-2 mRNA vaccines.