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

Shirin Heidari,Tracey Goodman,Alice Palmer-Ross

doi:10.3390/vaccines9111322

Shirin Heidari, Tracey Goodman + Show 1 more

Open Access

https://doi.org/10.3390/vaccines9111322

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Journal: Vaccines	Publication Date: Nov 15, 2021
Citations: 31	License type: CC BY 4.0

Affiliation: Biogen (Switzerland), World Health Organization

Abstract

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.

Highlights

Introduction of the Sex and GenderReporting inIn the face of the global public health emergency caused by coronavirus disease 2019(COVID-19), a safe and effective vaccine to prevent severe disease and death and minimize further spread of the virus is crucial
Our analysis shows that the majority of interventional COVID-19 vaccine studies were gender balanced
We examined the quality of reporting, according to the Sex and Gender Equity in Research (SAGER) Guidelines, in the six largest trials in our study, which account for 6.5 billion administered vaccine doses

Summary

Introduction

(COVID-19), a safe and effective vaccine to prevent severe disease and death and minimize further spread of the virus is crucial. Growing research is shedding light on observed sex and gender differences in the manifestation and mortality rates of COVID-19. Research into the different responses to COVID-19 vaccines between women and men is scarce. Past research shows there are immunological sex differences in response to self-antigens, pathogens, and vaccines [2]. Other research indicates that women experience more frequent and severe adverse events to certain vaccines compared to men [4,5]. Sex and gender differences in the infection, manifestation, or outcomes of COVID-19 should be acknowledged in the introduction.

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