Sex and Gender in COVID-19 Vaccine Research: Substantial Evidence Gaps Remain.
COVID-19
evidence
gender
gender equality
immunisation
safety
vaccine
Journal
Frontiers in global women's health
ISSN: 2673-5059
Titre abrégé: Front Glob Womens Health
Pays: Switzerland
ID NLM: 101776281
Informations de publication
Date de publication:
2021
2021
Historique:
received:
19
08
2021
accepted:
08
10
2021
entrez:
24
11
2021
pubmed:
25
11
2021
medline:
25
11
2021
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 34816252
doi: 10.3389/fgwh.2021.761511
pmc: PMC8593988
doi:
Types de publication
Journal Article
Review
Langues
eng
Pagination
761511Informations de copyright
Copyright © 2021 Vassallo, Shajahan, Harris, Hallam, Hockham, Womersley, Woodward and Sheel.
Déclaration de conflit d'intérêts
MW is a consultant to Amgen, Kyowa Kirin, and Freeline. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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