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Sex Disparities in Efficacy in COVID-19 Vaccines: A Systematic Review and Meta-Analysis

Sex differences in adaptive and innate immune responses have been shown to occur and anecdotal reports suggest that vaccine efficacy and safety may be sex-dependent. We investigated the influence of sex on the efficacy of COVID-19 vaccines through a systematic review and meta-analysis of clinical tr...

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Autores principales: Bignucolo, Alessia, Scarabel, Lucia, Mezzalira, Silvia, Polesel, Jerry, Cecchin, Erika, Toffoli, Giuseppe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8402482/
https://www.ncbi.nlm.nih.gov/pubmed/34451950
http://dx.doi.org/10.3390/vaccines9080825
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author Bignucolo, Alessia
Scarabel, Lucia
Mezzalira, Silvia
Polesel, Jerry
Cecchin, Erika
Toffoli, Giuseppe
author_facet Bignucolo, Alessia
Scarabel, Lucia
Mezzalira, Silvia
Polesel, Jerry
Cecchin, Erika
Toffoli, Giuseppe
author_sort Bignucolo, Alessia
collection PubMed
description Sex differences in adaptive and innate immune responses have been shown to occur and anecdotal reports suggest that vaccine efficacy and safety may be sex-dependent. We investigated the influence of sex on the efficacy of COVID-19 vaccines through a systematic review and meta-analysis of clinical trials on COVID-19 vaccines. The safety profile of COVID-19 vaccines was also investigated. A systematic review included eligible articles published in three databases and three websites. A meta-analysis of available data, stratified by sex, was conducted. Statistical analysis was performed using the Hartung–Knapp–Sidik–Jonkman method, as well as influence and heterogeneity analysis. Pooled analysis showed significantly higher efficacy, measured as the rate of new COVID-19 cases, in men compared to women in the vaccine group (OR = 0.67, 95% CI 0.48–0.94). No sex differences were found in the rate of new cases in the control group (OR = 0.92, 95% CI 0.78–1.09). Safety profiles derived from pharmacovigilance reports appear to indicate increased toxicity in women. In conclusion, evidence of a potential role of sex in COVID-19 vaccine efficacy was described. It strengthens the need to include sex as a core variable in the clinical trial design of COVID-19 vaccines.
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spelling pubmed-84024822021-08-29 Sex Disparities in Efficacy in COVID-19 Vaccines: A Systematic Review and Meta-Analysis Bignucolo, Alessia Scarabel, Lucia Mezzalira, Silvia Polesel, Jerry Cecchin, Erika Toffoli, Giuseppe Vaccines (Basel) Article Sex differences in adaptive and innate immune responses have been shown to occur and anecdotal reports suggest that vaccine efficacy and safety may be sex-dependent. We investigated the influence of sex on the efficacy of COVID-19 vaccines through a systematic review and meta-analysis of clinical trials on COVID-19 vaccines. The safety profile of COVID-19 vaccines was also investigated. A systematic review included eligible articles published in three databases and three websites. A meta-analysis of available data, stratified by sex, was conducted. Statistical analysis was performed using the Hartung–Knapp–Sidik–Jonkman method, as well as influence and heterogeneity analysis. Pooled analysis showed significantly higher efficacy, measured as the rate of new COVID-19 cases, in men compared to women in the vaccine group (OR = 0.67, 95% CI 0.48–0.94). No sex differences were found in the rate of new cases in the control group (OR = 0.92, 95% CI 0.78–1.09). Safety profiles derived from pharmacovigilance reports appear to indicate increased toxicity in women. In conclusion, evidence of a potential role of sex in COVID-19 vaccine efficacy was described. It strengthens the need to include sex as a core variable in the clinical trial design of COVID-19 vaccines. MDPI 2021-07-27 /pmc/articles/PMC8402482/ /pubmed/34451950 http://dx.doi.org/10.3390/vaccines9080825 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Bignucolo, Alessia
Scarabel, Lucia
Mezzalira, Silvia
Polesel, Jerry
Cecchin, Erika
Toffoli, Giuseppe
Sex Disparities in Efficacy in COVID-19 Vaccines: A Systematic Review and Meta-Analysis
title Sex Disparities in Efficacy in COVID-19 Vaccines: A Systematic Review and Meta-Analysis
title_full Sex Disparities in Efficacy in COVID-19 Vaccines: A Systematic Review and Meta-Analysis
title_fullStr Sex Disparities in Efficacy in COVID-19 Vaccines: A Systematic Review and Meta-Analysis
title_full_unstemmed Sex Disparities in Efficacy in COVID-19 Vaccines: A Systematic Review and Meta-Analysis
title_short Sex Disparities in Efficacy in COVID-19 Vaccines: A Systematic Review and Meta-Analysis
title_sort sex disparities in efficacy in covid-19 vaccines: a systematic review and meta-analysis
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8402482/
https://www.ncbi.nlm.nih.gov/pubmed/34451950
http://dx.doi.org/10.3390/vaccines9080825
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