Vassallo Amy, Shajahan Sultana, Harris Katie, Hallam Laura, Hockham Carinna, Womersley Kate, Woodward Mark, Sheel Meru
The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
The George Institute for Global Health, School of Public Health, Imperial College London, London, United Kingdom.
Front Glob Womens Health. 2021 Nov 1;2:761511. doi: 10.3389/fgwh.2021.761511. eCollection 2021.
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.
自新冠疫情开始以来，全球都呼吁提供按性别分类的数据，这些数据揭示了有关新冠病毒检测、发病率、严重程度、住院率和死亡率的重要发现。本综述总结了来自实验性和观察性研究的新冠疫苗有效性、效力和安全性的证据基础，并探讨了以下问题：（1）在疫苗研究中，男性和女性的招募和代表性是否相同；（2）研究结果是否按性别进行了呈现或分析；（3）是否有证据表明结果存在性别差异。通过在PubMed上进行检索，有41篇文章符合纳入标准，包括7项随机对照试验（RCT）、11项队列研究、8项横断面调查、8项常规监测研究和7个病例系列。总体而言，随机对照试验中男性和女性的代表性相同；然而，观察性研究中女性的比例更高。在10项有疗效数据的研究中，只有3项（30%）呈现了按性别分类的结果。35项研究纳入了安全性数据，其中只有12项（34%）按性别呈现了数据。对于那些确实呈现了分类数据的研究，总体而言，报告不良事件的参与者大多数是女性。按性别对新冠疫苗数据进行报告和分析的情况很少。研究应以对性别敏感的方式设计，以便呈现并在可能的情况下按性别分析数据，以确保有一个强大而具体的有效性和安全性数据证据基础，有助于建立公众信心并提高疫苗接种率。
