Bignucolo Alessia, Scarabel Lucia, Mezzalira Silvia, Polesel Jerry, Cecchin Erika, Toffoli Giuseppe
Experimental and Clinical Pharmacology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Via Franco Gallini 2, 33081 Aviano, Italy.
Unit of Cancer Epidemiology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Via Franco Gallini 2, 33081 Aviano, Italy.
Vaccines (Basel). 2021 Jul 27;9(8):825. doi: 10.3390/vaccines9080825.
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.
适应性和先天性免疫反应中的性别差异已被证实存在，轶事报道表明疫苗的效力和安全性可能取决于性别。我们通过对新冠疫苗临床试验的系统评价和荟萃分析，研究了性别对新冠疫苗效力的影响。同时也对新冠疫苗的安全性进行了调查。系统评价纳入了在三个数据库和三个网站上发表的符合条件的文章。对现有数据按性别进行分层荟萃分析。采用Hartung-Knapp-Sidik-Jonkman方法进行统计分析，以及影响和异质性分析。汇总分析显示，在疫苗组中，以新冠新发病例率衡量，男性的效力显著高于女性（OR = 0.67，95% CI 0.48 - 0.94）。在对照组中，新发病例率未发现性别差异（OR = 0.92，95% CI 0.78 - 1.09）。药物警戒报告得出的安全性数据似乎表明女性的毒性增加。总之，描述了性别在新冠疫苗效力中潜在作用的证据。这强化了在新冠疫苗临床试验设计中将性别作为核心变量纳入的必要性。
