Sex and Gender in COVID-19 Vaccine Research: Substantial Evidence Gaps Remain

Since the start of the COVID-19 pandemic there has been a global call for sex/gender-disaggregated data to be made available, which has uncovered important findings about COVID-19 testing, incidence, severity, hospitalisations, and deaths. This mini review scopes the evidence base for efficacy, effe...

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Veröffentlicht in:Frontiers in Global Women's Health Jg. 2; S. 761511
Hauptverfasser: Vassallo, Amy, Shajahan, Sultana, Harris, Katie, Hallam, Laura, Hockham, Carinna, Womersley, Kate, Woodward, Mark, Sheel, Meru
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Switzerland Frontiers Media SA 01.11.2021
Frontiers Media S.A
Schlagworte:
Case studies
Cohort analysis
COVID-19
COVID-19 diagnostic tests
COVID-19 vaccines
Cross-sectional studies
evidence
Gender differences
gender equality
Global Women's Health
immunisation
Medical personnel
Observational studies
Pandemics
safety
Surveillance
vaccine
Womens health
COVID-19
vaccine
evidence
gender
gender equality
safety
immunisation
ISSN:2673-5059, 2673-5059
Online-Zugang:Volltext
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Zusammenfassung:Since the start of the COVID-19 pandemic there has been a global call for sex/gender-disaggregated data to be made available, which has uncovered important findings about COVID-19 testing, incidence, severity, hospitalisations, and deaths. This mini review scopes the evidence base for efficacy, effectiveness, and safety of COVID-19 vaccines from both experimental and observational research, and asks whether (1) women and men were equally recruited and represented in vaccine research, (2) the outcomes of studies were presented or analysed by sex and/or gender, and (3) there is evidence of sex and/or gender differences in outcomes. Following a PubMed search, 41 articles were eligible for inclusion, including seven randomised controlled trials (RCTs), 11 cohort studies, eight cross-sectional surveys, eight routine surveillance studies, and seven case series. Overall, the RCTs contained equal representation of women and men; however, the observational studies contained a higher percentage of women. Of 10 studies with efficacy data, only three (30%) presented sex/gender-disaggregated results. Safety data was included in 35 studies and only 12 (34%) of these presented data by sex/gender. For those that did present disaggregated data, overall, the majority of participants reporting adverse events were women. There is a paucity of reporting and analysis of COVID-19 vaccine data by sex/gender. Research should be designed in a gender-sensitive way to present and, where possible analyse, data by sex/gender to ensure that there is a robust and specific evidence base of efficacy and safety data to assist in building public confidence and promote high vaccine coverage.
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Reviewed by: Renee Bolijn, Academic Medical Center, Netherlands; Julia Smith, Simon Fraser University, Canada
Edited by: Sanni Yaya, University of Ottawa, Canada
This article was submitted to Sex and Gender Differences in Disease, a section of the journal Frontiers in Global Women's Health
ISSN:2673-5059
2673-5059
DOI:10.3389/fgwh.2021.761511