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First-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland

C. R. Simpson, T. Shi Orcid Logo, E. Vasileiou, S. V. Katikireddi Orcid Logo, S. Kerr, E. Moore, C. McCowan, U. Agrawal, S. A. Shah Orcid Logo, L. D. Ritchie, J. Murray, J. Pan, D. T. Bradley Orcid Logo, S. J. Stock Orcid Logo, R. Wood, A. Chuter, J. Beggs, H. R. Stagg, M. Joy, R. S. M. Tsang Orcid Logo, S. de Lusignan Orcid Logo, R. Hobbs, Ronan Lyons Orcid Logo, Fatemeh Torabi Orcid Logo, Stuart Bedston, M. O’Leary, Ashley Akbari Orcid Logo, J. McMenamin, C. Robertson, A. Sheikh Orcid Logo

Nature Medicine, Volume: 27, Issue: 7, Pages: 1290 - 1297

Swansea University Authors: Ronan Lyons Orcid Logo, Fatemeh Torabi Orcid Logo, Stuart Bedston, Ashley Akbari Orcid Logo

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DOI (Published version): 10.1038/s41591-021-01408-4

Abstract

Reports of ChAdOx1 vaccine–associated thrombocytopenia and vascular adverse events have led to some countries restricting its use. Using a national prospective cohort, we estimated associations between exposure to first-dose ChAdOx1 or BNT162b2 vaccination and hematological and vascular adverse even...

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Published in: Nature Medicine
ISSN: 1078-8956 1546-170X
Published: Springer Science and Business Media LLC 2021
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Using a national prospective cohort, we estimated associations between exposure to first-dose ChAdOx1 or BNT162b2 vaccination and hematological and vascular adverse events using a nested incident-matched case-control study and a confirmatory self-controlled case series (SCCS) analysis. An association was found between ChAdOx1 vaccination and idiopathic thrombocytopenic purpura (ITP) (0&#x2013;27 d after vaccination; adjusted rate ratio (aRR) = 5.77, 95% confidence interval (CI), 2.41&#x2013;13.83), with an estimated incidence of 1.13 (0.62&#x2013;1.63) cases per 100,000 doses. An SCCS analysis confirmed that this was unlikely due to bias (RR&#x2009;=&#x2009;1.98 (1.29&#x2013;3.02)). There was also an increased risk for arterial thromboembolic events (aRR = 1.22, 1.12&#x2013;1.34) 0&#x2013;27 d after vaccination, with an SCCS RR of 0.97 (0.93&#x2013;1.02). For hemorrhagic events 0&#x2013;27 d after vaccination, the aRR was 1.48 (1.12&#x2013;1.96), with an SCCS RR of 0.95 (0.82&#x2013;1.11). A first dose of ChAdOx1 was found to be associated with small increased risks of ITP, with suggestive evidence of an increased risk of arterial thromboembolic and hemorrhagic events. The attenuation of effect found in the SCCS analysis means that there is the potential for overestimation of the reported results, which might indicate the presence of some residual confounding or confounding by indication. Public health authorities should inform their jurisdictions of these relatively small increased risks associated with ChAdOx1. 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spelling 2022-08-16T13:36:09.2325586 v2 57111 2021-06-12 First-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland 83efcf2a9dfcf8b55586999d3d152ac6 0000-0001-5225-000X Ronan Lyons Ronan Lyons true false f569591e1bfb0e405b8091f99fec45d3 0000-0002-5853-4625 Fatemeh Torabi Fatemeh Torabi true false c79d07eaba5c9515c0df82b372b76a41 Stuart Bedston Stuart Bedston true false aa1b025ec0243f708bb5eb0a93d6fb52 0000-0003-0814-0801 Ashley Akbari Ashley Akbari true false 2021-06-12 HDAT Reports of ChAdOx1 vaccine–associated thrombocytopenia and vascular adverse events have led to some countries restricting its use. Using a national prospective cohort, we estimated associations between exposure to first-dose ChAdOx1 or BNT162b2 vaccination and hematological and vascular adverse events using a nested incident-matched case-control study and a confirmatory self-controlled case series (SCCS) analysis. An association was found between ChAdOx1 vaccination and idiopathic thrombocytopenic purpura (ITP) (0–27 d after vaccination; adjusted rate ratio (aRR) = 5.77, 95% confidence interval (CI), 2.41–13.83), with an estimated incidence of 1.13 (0.62–1.63) cases per 100,000 doses. An SCCS analysis confirmed that this was unlikely due to bias (RR = 1.98 (1.29–3.02)). There was also an increased risk for arterial thromboembolic events (aRR = 1.22, 1.12–1.34) 0–27 d after vaccination, with an SCCS RR of 0.97 (0.93–1.02). For hemorrhagic events 0–27 d after vaccination, the aRR was 1.48 (1.12–1.96), with an SCCS RR of 0.95 (0.82–1.11). A first dose of ChAdOx1 was found to be associated with small increased risks of ITP, with suggestive evidence of an increased risk of arterial thromboembolic and hemorrhagic events. The attenuation of effect found in the SCCS analysis means that there is the potential for overestimation of the reported results, which might indicate the presence of some residual confounding or confounding by indication. Public health authorities should inform their jurisdictions of these relatively small increased risks associated with ChAdOx1. No positive associations were seen between BNT162b2 and thrombocytopenic, thromboembolic and hemorrhagic events. Journal Article Nature Medicine 27 7 1290 1297 Springer Science and Business Media LLC 1078-8956 1546-170X 1 7 2021 2021-07-01 10.1038/s41591-021-01408-4 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University MC_PC_19004/MRC_/Medical Research Council/United Kingdom MC_PC_19075/MRC_/Medical Research Council/United Kingdom MC_PC_13043/MRC_/Medical Research Council/United Kingdom MR/K006525/1/MRC_/Medical Research Council/United Kingdom MC_PC_20058/MRC_/Medical Research Council/United Kingdom 2022-08-16T13:36:09.2325586 2021-06-12T16:20:58.0499674 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine C. R. Simpson 1 T. Shi 0000-0002-4101-4535 2 E. Vasileiou 3 S. V. Katikireddi 0000-0001-6593-9092 4 S. Kerr 5 E. Moore 6 C. McCowan 7 U. Agrawal 8 S. A. Shah 0000-0001-5672-0443 9 L. D. Ritchie 10 J. Murray 11 J. Pan 12 D. T. Bradley 0000-0003-1468-1823 13 S. J. Stock 0000-0003-4308-856x 14 R. Wood 15 A. Chuter 16 J. Beggs 17 H. R. Stagg 18 M. Joy 19 R. S. M. Tsang 0000-0002-2520-526x 20 S. de Lusignan 0000-0002-8553-2641 21 R. Hobbs 22 Ronan Lyons 0000-0001-5225-000X 23 Fatemeh Torabi 0000-0002-5853-4625 24 Stuart Bedston 25 M. O’Leary 26 Ashley Akbari 0000-0003-0814-0801 27 J. McMenamin 28 C. Robertson 29 A. Sheikh 0000-0001-7022-3056 30 57111__20259__37620b8ef51343f5b87f2c0fe5b65377.pdf 57111.pdf 2021-06-25T12:33:32.6992328 Output 2770589 application/pdf Version of Record true © The Author(s) 2021. This article is licensed under a Creative Commons Attribution 4.0 International License true eng http://creativecommons.org/licenses/by/4.0/
title First-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland
spellingShingle First-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland
Ronan Lyons
Fatemeh Torabi
Stuart Bedston
Ashley Akbari
title_short First-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland
title_full First-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland
title_fullStr First-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland
title_full_unstemmed First-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland
title_sort First-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland
author_id_str_mv 83efcf2a9dfcf8b55586999d3d152ac6
f569591e1bfb0e405b8091f99fec45d3
c79d07eaba5c9515c0df82b372b76a41
aa1b025ec0243f708bb5eb0a93d6fb52
author_id_fullname_str_mv 83efcf2a9dfcf8b55586999d3d152ac6_***_Ronan Lyons
f569591e1bfb0e405b8091f99fec45d3_***_Fatemeh Torabi
c79d07eaba5c9515c0df82b372b76a41_***_Stuart Bedston
aa1b025ec0243f708bb5eb0a93d6fb52_***_Ashley Akbari
author Ronan Lyons
Fatemeh Torabi
Stuart Bedston
Ashley Akbari
author2 C. R. Simpson
T. Shi
E. Vasileiou
S. V. Katikireddi
S. Kerr
E. Moore
C. McCowan
U. Agrawal
S. A. Shah
L. D. Ritchie
J. Murray
J. Pan
D. T. Bradley
S. J. Stock
R. Wood
A. Chuter
J. Beggs
H. R. Stagg
M. Joy
R. S. M. Tsang
S. de Lusignan
R. Hobbs
Ronan Lyons
Fatemeh Torabi
Stuart Bedston
M. O’Leary
Ashley Akbari
J. McMenamin
C. Robertson
A. Sheikh
format Journal article
container_title Nature Medicine
container_volume 27
container_issue 7
container_start_page 1290
publishDate 2021
institution Swansea University
issn 1078-8956
1546-170X
doi_str_mv 10.1038/s41591-021-01408-4
publisher Springer Science and Business Media LLC
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
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description Reports of ChAdOx1 vaccine–associated thrombocytopenia and vascular adverse events have led to some countries restricting its use. Using a national prospective cohort, we estimated associations between exposure to first-dose ChAdOx1 or BNT162b2 vaccination and hematological and vascular adverse events using a nested incident-matched case-control study and a confirmatory self-controlled case series (SCCS) analysis. An association was found between ChAdOx1 vaccination and idiopathic thrombocytopenic purpura (ITP) (0–27 d after vaccination; adjusted rate ratio (aRR) = 5.77, 95% confidence interval (CI), 2.41–13.83), with an estimated incidence of 1.13 (0.62–1.63) cases per 100,000 doses. An SCCS analysis confirmed that this was unlikely due to bias (RR = 1.98 (1.29–3.02)). There was also an increased risk for arterial thromboembolic events (aRR = 1.22, 1.12–1.34) 0–27 d after vaccination, with an SCCS RR of 0.97 (0.93–1.02). For hemorrhagic events 0–27 d after vaccination, the aRR was 1.48 (1.12–1.96), with an SCCS RR of 0.95 (0.82–1.11). A first dose of ChAdOx1 was found to be associated with small increased risks of ITP, with suggestive evidence of an increased risk of arterial thromboembolic and hemorrhagic events. The attenuation of effect found in the SCCS analysis means that there is the potential for overestimation of the reported results, which might indicate the presence of some residual confounding or confounding by indication. Public health authorities should inform their jurisdictions of these relatively small increased risks associated with ChAdOx1. No positive associations were seen between BNT162b2 and thrombocytopenic, thromboembolic and hemorrhagic events.
published_date 2021-07-01T04:12:36Z
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