A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials

Sex and gender have implications for COVID-19 vaccine efficacy and adverse effects from the vaccine. As vaccination is one of the key responses to the COVID-19 pandemic, it is vital that sex and gender differences be acknowledged, measured, and analysed in clinical research. Here, we systematically...

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Autores principales:	Shirin Heidari, Alice Palmer-Ross, Tracey Goodman
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	COVID-19 vaccines sex gender SAGER Guidelines Medicine R
Acceso en línea:	https://doaj.org/article/ae794618f1114727a09036cfa6b1e744
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spelling	oai:doaj.org-article:ae794618f1114727a09036cfa6b1e7442021-11-25T19:11:19ZA Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials10.3390/vaccines91113222076-393Xhttps://doaj.org/article/ae794618f1114727a09036cfa6b1e7442021-11-01T00:00:00Zhttps://www.mdpi.com/2076-393X/9/11/1322https://doaj.org/toc/2076-393XSex and gender have implications for COVID-19 vaccine efficacy and adverse effects from the vaccine. As vaccination is one of the key responses to the COVID-19 pandemic, it is vital that sex and gender differences be acknowledged, measured, and analysed in clinical research. Here, we systematically review published COVID-19 vaccine trials, both interventional and observational, to assess the quality of reporting of sex and gender. Of the 75 clinical trials on COVID-19 vaccines included in this review, only 24% presented their main outcome data disaggregated by sex, and only 13% included any discussion of the implications of their study for women and men. Considering the sex differences in adverse events after vaccination, and the gendered aspects of vaccine hesitancy, these oversights in clinical research on vaccines have implications for recovery from the COVID-19 pandemic and for wider public health.Shirin HeidariAlice Palmer-RossTracey GoodmanMDPI AGarticleCOVID-19vaccinessexgenderSAGER GuidelinesMedicineRENVaccines, Vol 9, Iss 1322, p 1322 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	COVID-19 vaccines sex gender SAGER Guidelines Medicine R
spellingShingle	COVID-19 vaccines sex gender SAGER Guidelines Medicine R Shirin Heidari Alice Palmer-Ross Tracey Goodman A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials
description	Sex and gender have implications for COVID-19 vaccine efficacy and adverse effects from the vaccine. As vaccination is one of the key responses to the COVID-19 pandemic, it is vital that sex and gender differences be acknowledged, measured, and analysed in clinical research. Here, we systematically review published COVID-19 vaccine trials, both interventional and observational, to assess the quality of reporting of sex and gender. Of the 75 clinical trials on COVID-19 vaccines included in this review, only 24% presented their main outcome data disaggregated by sex, and only 13% included any discussion of the implications of their study for women and men. Considering the sex differences in adverse events after vaccination, and the gendered aspects of vaccine hesitancy, these oversights in clinical research on vaccines have implications for recovery from the COVID-19 pandemic and for wider public health.
format	article
author	Shirin Heidari Alice Palmer-Ross Tracey Goodman
author_facet	Shirin Heidari Alice Palmer-Ross Tracey Goodman
author_sort	Shirin Heidari
title	A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials
title_short	A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials
title_full	A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials
title_fullStr	A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials
title_full_unstemmed	A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials
title_sort	systematic review of the sex and gender reporting in covid-19 clinical trials
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/ae794618f1114727a09036cfa6b1e744
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A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials

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