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

Authors :
Alessia Bignucolo
Lucia Scarabel
Silvia Mezzalira
Jerry Polesel
Erika Cecchin
Giuseppe Toffoli
Source :
Vaccines, Vol 9, Iss 8, p 825 (2021)
Publication Year :
2021
Publisher :
MDPI AG, 2021.

Abstract

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.

Details

Language :
English
ISSN :
2076393X
Volume :
9
Issue :
8
Database :
Directory of Open Access Journals
Journal :
Vaccines
Publication Type :
Academic Journal
Accession number :
edsdoj.0655f7f408254e73b3b79293479e499b
Document Type :
article
Full Text :
https://doi.org/10.3390/vaccines9080825