Thromboembolic and hemorrhagic risks after vaccination against SARS-CoV-2: a systematic review and meta-analysis of randomized controlled trials

Abstract Background Thromboembolic and bleeding events after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are major public concerns leading to vaccine hesitancy. Due to low incidence, an individual randomized controlled trial (RCT) is underpowered to determine whe...

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Autores principales:	Noppacharn Uaprasert, Krissana Panrong, Ponlapat Rojnuckarin, Thita Chiasakul
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Thromboembolism Hemorrhage Vaccine SARS-CoV-2 Diseases of the blood and blood-forming organs RC633-647.5
Acceso en línea:	https://doaj.org/article/60d90bd8c2444aebb5c495d3a2b9c9c5
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spelling	oai:doaj.org-article:60d90bd8c2444aebb5c495d3a2b9c9c52021-11-14T12:28:48ZThromboembolic and hemorrhagic risks after vaccination against SARS-CoV-2: a systematic review and meta-analysis of randomized controlled trials10.1186/s12959-021-00340-41477-9560https://doaj.org/article/60d90bd8c2444aebb5c495d3a2b9c9c52021-11-01T00:00:00Zhttps://doi.org/10.1186/s12959-021-00340-4https://doaj.org/toc/1477-9560Abstract Background Thromboembolic and bleeding events after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are major public concerns leading to vaccine hesitancy. Due to low incidence, an individual randomized controlled trial (RCT) is underpowered to determine whether SARS-CoV-2 vaccines increase the risks of thromboembolism and hemorrhage. Methods We performed a literature search using PubMed, EMBASE, Cochrane, medRxiv databases, and reference lists of relevant articles to identify RCTs that reported thromboembolic, hemorrhagic events, and thromboembolism/hemorrhage-related death after SARS-CoV-2 vaccination. The primary aim of this systematic review and meta-analysis was to estimate the pooled thromboembolic risk related to SARS-CoV-2 vaccines compared to placebo. The secondary outcomes included estimating the risks of arterial thromboembolism (ATE), venous thromboembolisms (VTE), hemorrhage, thrombocytopenia, and thromboembolism/hemorrhage-related death. Results Eight RCTs of 4 vaccine platforms comprised of 195,196 participants were retrieved. SARS-CoV-2 vaccines were not associated with an increased risk of overall thromboembolism (risk ratio [RR], 1.14; 95% CI [confidence interval], 0.61–2.14; I2 = 35%), ATE (RR, 0.97; 95% CI, 0.46–2.06; I2 = 21%), VTE (RR, 1.47; 95% CI, 0.72–2.99; I2 = 0%), hemorrhage (RR, 0.97; 95% CI, 0.35–2.68; I2 = 0), and thromboembolism/hemorrhage-related death (RR, 0.53; 95% CI, 0.16–1.79; I2 = 0). Compared to the baseline estimated risk of these outcomes in participants administered placebos, the risk differences with vaccines were very small and not statistically significant. These findings were consistent in the subgroup analysis across 4 vaccine platforms. Conclusion Vaccines against SARS-CoV-2 are not associated with an increased risk of thromboembolism, hemorrhage, and thromboembolism/hemorrhage-related death.Noppacharn UaprasertKrissana PanrongPonlapat RojnuckarinThita ChiasakulBMCarticleThromboembolismHemorrhageVaccineSARS-CoV-2Diseases of the blood and blood-forming organsRC633-647.5ENThrombosis Journal, Vol 19, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Thromboembolism Hemorrhage Vaccine SARS-CoV-2 Diseases of the blood and blood-forming organs RC633-647.5
spellingShingle	Thromboembolism Hemorrhage Vaccine SARS-CoV-2 Diseases of the blood and blood-forming organs RC633-647.5 Noppacharn Uaprasert Krissana Panrong Ponlapat Rojnuckarin Thita Chiasakul Thromboembolic and hemorrhagic risks after vaccination against SARS-CoV-2: a systematic review and meta-analysis of randomized controlled trials
description	Abstract Background Thromboembolic and bleeding events after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are major public concerns leading to vaccine hesitancy. Due to low incidence, an individual randomized controlled trial (RCT) is underpowered to determine whether SARS-CoV-2 vaccines increase the risks of thromboembolism and hemorrhage. Methods We performed a literature search using PubMed, EMBASE, Cochrane, medRxiv databases, and reference lists of relevant articles to identify RCTs that reported thromboembolic, hemorrhagic events, and thromboembolism/hemorrhage-related death after SARS-CoV-2 vaccination. The primary aim of this systematic review and meta-analysis was to estimate the pooled thromboembolic risk related to SARS-CoV-2 vaccines compared to placebo. The secondary outcomes included estimating the risks of arterial thromboembolism (ATE), venous thromboembolisms (VTE), hemorrhage, thrombocytopenia, and thromboembolism/hemorrhage-related death. Results Eight RCTs of 4 vaccine platforms comprised of 195,196 participants were retrieved. SARS-CoV-2 vaccines were not associated with an increased risk of overall thromboembolism (risk ratio [RR], 1.14; 95% CI [confidence interval], 0.61–2.14; I2 = 35%), ATE (RR, 0.97; 95% CI, 0.46–2.06; I2 = 21%), VTE (RR, 1.47; 95% CI, 0.72–2.99; I2 = 0%), hemorrhage (RR, 0.97; 95% CI, 0.35–2.68; I2 = 0), and thromboembolism/hemorrhage-related death (RR, 0.53; 95% CI, 0.16–1.79; I2 = 0). Compared to the baseline estimated risk of these outcomes in participants administered placebos, the risk differences with vaccines were very small and not statistically significant. These findings were consistent in the subgroup analysis across 4 vaccine platforms. Conclusion Vaccines against SARS-CoV-2 are not associated with an increased risk of thromboembolism, hemorrhage, and thromboembolism/hemorrhage-related death.
format	article
author	Noppacharn Uaprasert Krissana Panrong Ponlapat Rojnuckarin Thita Chiasakul
author_facet	Noppacharn Uaprasert Krissana Panrong Ponlapat Rojnuckarin Thita Chiasakul
author_sort	Noppacharn Uaprasert
title	Thromboembolic and hemorrhagic risks after vaccination against SARS-CoV-2: a systematic review and meta-analysis of randomized controlled trials
title_short	Thromboembolic and hemorrhagic risks after vaccination against SARS-CoV-2: a systematic review and meta-analysis of randomized controlled trials
title_full	Thromboembolic and hemorrhagic risks after vaccination against SARS-CoV-2: a systematic review and meta-analysis of randomized controlled trials
title_fullStr	Thromboembolic and hemorrhagic risks after vaccination against SARS-CoV-2: a systematic review and meta-analysis of randomized controlled trials
title_full_unstemmed	Thromboembolic and hemorrhagic risks after vaccination against SARS-CoV-2: a systematic review and meta-analysis of randomized controlled trials
title_sort	thromboembolic and hemorrhagic risks after vaccination against sars-cov-2: a systematic review and meta-analysis of randomized controlled trials
publisher	BMC
publishDate	2021
url	https://doaj.org/article/60d90bd8c2444aebb5c495d3a2b9c9c5
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Thromboembolic and hemorrhagic risks after vaccination against SARS-CoV-2: a systematic review and meta-analysis of randomized controlled trials

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