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Abstract
Background and Objectives Cerebral venous sinus thrombosis (CVST) as a part of the thrombosis and thrombocytopenia syndrome is a rare adverse drug reaction of severe acute respiratory syndrome coronavirus disease 2 (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 a first dose of 4 SARS-CoV-2 vaccinations using data from the European Medicines Agency's EudraVigilance database (until June 13, 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% confidence interval [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- to 24-year-old 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 years compared to ≥60 years 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.
Glossary
- ADR=
- adverse drug reaction;
- CI=
- confidence interval;
- COVID-19=
- coronavirus disease 2019;
- CVST=
- cerebral venous sinus thrombosis;
- ECDC=
- European Centre for Disease Prevention and Control;
- EEA=
- European Economic Area;
- EMA=
- European Medicines Agency;
- HLGT=
- High Level Group Term;
- MedDRA=
- Medical Dictionary for Regulatory Activities;
- PT=
- preferred term;
- SARS-CoV-2=
- severe acute respiratory syndrome coronavirus disease;
- TTS=
- thrombosis and thrombocytopenia syndrome;
- VITT=
- vaccine-induced immune thrombotic thrombocytopenia
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
↵* These authors contributed equally to this work as first authors.
↵† These authors contributed equally to this work as senior authors.
COVID-19 Resources: NPub.org/COVID19
CME Course: NPub.org/cmelist
- Received August 24, 2021.
- Accepted in final form November 23, 2021.
- © 2021 American Academy of Neurology
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