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Risk of venous thrombotic events and thrombocytopenia in sequential time periods after ChAdOx1 and BNT162b2 COVID-19 vaccines: A national cohort study in England

BACKGROUND: Thrombosis with thrombocytopenia, or thrombocytopenia on its own, have been reported after Covid-19 vaccines. We assessed the risk after ChAdOx1 adenovirus-vector and BNT162b2 mRNA vaccines in a national cohort study in England. METHODS: Hospital admissions for a cerebral venous thrombos...

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Autores principales: Andrews, Nick J, Stowe, Julia, Ramsay, Mary EB, Miller, Elizabeth
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8668159/
https://www.ncbi.nlm.nih.gov/pubmed/34927118
http://dx.doi.org/10.1016/j.lanepe.2021.100260
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author Andrews, Nick J
Stowe, Julia
Ramsay, Mary EB
Miller, Elizabeth
author_facet Andrews, Nick J
Stowe, Julia
Ramsay, Mary EB
Miller, Elizabeth
author_sort Andrews, Nick J
collection PubMed
description BACKGROUND: Thrombosis with thrombocytopenia, or thrombocytopenia on its own, have been reported after Covid-19 vaccines. We assessed the risk after ChAdOx1 adenovirus-vector and BNT162b2 mRNA vaccines in a national cohort study in England. METHODS: Hospital admissions for a cerebral venous thrombosis (CVT), other venous thrombosis or thrombocytopenia between 30(th) November 2020 and 18(th) April 2021 were linked to the national Covid-19 immunisation register. The incidence of events by dose in pre-defined post-vaccination risk periods relative to the unvaccinated cohort was estimated after adjustment for age, gender, co-morbidities, care home residency and health/social care worker status. Elevated relative incidence (RI) estimates with p<0.001 were considered strong evidence of an association. FINDINGS: The RI for CVT after a first ChAdOx1 dose in 15-39 and 40-64 year olds was 8.7 (95% confidence interval 5.8-13.0) and 2.2 (1.4-3.2) respectively, p<0.001. The elevated risk period in 15-39 year olds was highest 4-13 days post-vaccination (16.3, 9.9-27.0). The attributable risk (AR) was 16.1 per million doses for 15-39 and 3.2 per million for 40-64 year olds. RIs for other thrombosis admissions were elevated in these age groups with ARs of 36.3 and 16.4 per million respectively as were RIs for thrombocytopenia, with ARs of 11.3 and 10.1 per million respectively. No elevated RIs were found for 65+ year olds or after a second ChAdOx1 dose, nor for BNT162b2 vaccine recipients of any age. INTERPRETATION: This epidemiological study shows an increased risk of thrombotic episodes and thrombocytopenia in adults under 65 years of age within a month of a first dose of ChAdOx1 vaccine but not after the BNT162b2 vaccine. FUNDING: EM receives support from the National Institute for Health Research (NIHR) Health Protection Research Unit in Immunisation at the London School of Hygiene and Tropical Medicine in partnership with Public Health England (Grant Reference NIHR200929).
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spelling pubmed-86681592021-12-14 Risk of venous thrombotic events and thrombocytopenia in sequential time periods after ChAdOx1 and BNT162b2 COVID-19 vaccines: A national cohort study in England Andrews, Nick J Stowe, Julia Ramsay, Mary EB Miller, Elizabeth Lancet Reg Health Eur Article BACKGROUND: Thrombosis with thrombocytopenia, or thrombocytopenia on its own, have been reported after Covid-19 vaccines. We assessed the risk after ChAdOx1 adenovirus-vector and BNT162b2 mRNA vaccines in a national cohort study in England. METHODS: Hospital admissions for a cerebral venous thrombosis (CVT), other venous thrombosis or thrombocytopenia between 30(th) November 2020 and 18(th) April 2021 were linked to the national Covid-19 immunisation register. The incidence of events by dose in pre-defined post-vaccination risk periods relative to the unvaccinated cohort was estimated after adjustment for age, gender, co-morbidities, care home residency and health/social care worker status. Elevated relative incidence (RI) estimates with p<0.001 were considered strong evidence of an association. FINDINGS: The RI for CVT after a first ChAdOx1 dose in 15-39 and 40-64 year olds was 8.7 (95% confidence interval 5.8-13.0) and 2.2 (1.4-3.2) respectively, p<0.001. The elevated risk period in 15-39 year olds was highest 4-13 days post-vaccination (16.3, 9.9-27.0). The attributable risk (AR) was 16.1 per million doses for 15-39 and 3.2 per million for 40-64 year olds. RIs for other thrombosis admissions were elevated in these age groups with ARs of 36.3 and 16.4 per million respectively as were RIs for thrombocytopenia, with ARs of 11.3 and 10.1 per million respectively. No elevated RIs were found for 65+ year olds or after a second ChAdOx1 dose, nor for BNT162b2 vaccine recipients of any age. INTERPRETATION: This epidemiological study shows an increased risk of thrombotic episodes and thrombocytopenia in adults under 65 years of age within a month of a first dose of ChAdOx1 vaccine but not after the BNT162b2 vaccine. FUNDING: EM receives support from the National Institute for Health Research (NIHR) Health Protection Research Unit in Immunisation at the London School of Hygiene and Tropical Medicine in partnership with Public Health England (Grant Reference NIHR200929). Elsevier 2021-12-13 /pmc/articles/PMC8668159/ /pubmed/34927118 http://dx.doi.org/10.1016/j.lanepe.2021.100260 Text en © 2021 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Andrews, Nick J
Stowe, Julia
Ramsay, Mary EB
Miller, Elizabeth
Risk of venous thrombotic events and thrombocytopenia in sequential time periods after ChAdOx1 and BNT162b2 COVID-19 vaccines: A national cohort study in England
title Risk of venous thrombotic events and thrombocytopenia in sequential time periods after ChAdOx1 and BNT162b2 COVID-19 vaccines: A national cohort study in England
title_full Risk of venous thrombotic events and thrombocytopenia in sequential time periods after ChAdOx1 and BNT162b2 COVID-19 vaccines: A national cohort study in England
title_fullStr Risk of venous thrombotic events and thrombocytopenia in sequential time periods after ChAdOx1 and BNT162b2 COVID-19 vaccines: A national cohort study in England
title_full_unstemmed Risk of venous thrombotic events and thrombocytopenia in sequential time periods after ChAdOx1 and BNT162b2 COVID-19 vaccines: A national cohort study in England
title_short Risk of venous thrombotic events and thrombocytopenia in sequential time periods after ChAdOx1 and BNT162b2 COVID-19 vaccines: A national cohort study in England
title_sort risk of venous thrombotic events and thrombocytopenia in sequential time periods after chadox1 and bnt162b2 covid-19 vaccines: a national cohort study in england
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8668159/
https://www.ncbi.nlm.nih.gov/pubmed/34927118
http://dx.doi.org/10.1016/j.lanepe.2021.100260
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