Sex Disparities in Efficacy in COVID-19 Vaccines: A Systematic Review and Meta-Analysis.
Sex Disparities in Efficacy in COVID-19 Vaccines: A Systematic Review and Meta-Analysis.
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DOI：
10.3390/vaccines9080825
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发表时间：
2021-07-27
期刊：
影响因子：
7.8
通讯作者：
Toffoli G
中科院分区：
文献类型：
--
作者：
Bignucolo A;Scarabel L;Mezzalira S;Polesel J;Cecchin E;Toffoli G
适应性和先天免疫反应的性别差异已被证明，坊间报道表明疫苗的有效性和安全性可能与性别有关。我们通过对新冠肺炎疫苗临床试验的系统回顾和荟萃分析，探讨了性别对新冠肺炎疫苗效果的影响。还对新冠肺炎疫苗的安全性进行了调查。一项系统审查包括在三个数据库和三个网站上发表的合格文章。对现有数据进行了荟萃分析，按性别分层。采用Hartung-Knapp-Sidik-Jonkman方法进行统计分析，并进行影响分析和异质性分析。合并分析显示，以新发新冠肺炎病例比率衡量，疫苗组男性的疗效显著高于女性(OR=0.67，95%CI 0.48-0.94)。对照组新发病例数无性别差异(OR=0.92，95%CI为0.78~1.09)。从药物警戒报告中得出的安全性描述似乎表明，女性的毒性增加。最后，描述了性别在新冠肺炎疫苗效力中的潜在作用的证据。它强化了将性别作为核心变量纳入新冠肺炎疫苗临床试验设计的必要性。
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.
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影响因子：
15.8
作者：
Moher D;Liberati A;Tetzlaff J;Altman DG;PRISMA Group
通讯作者：
PRISMA Group
BNT162B2 mRNA COVID-19疫苗的安全性和功效。
DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
DOI：
10.1056/nejmoa2104840
发表时间：
2021-06-03
期刊：
The New England journal of medicine
影响因子：
--
作者：
Greinacher A;Thiele T;Warkentin TE;Weisser K;Kyrle PA;Eichinger S
通讯作者：
Eichinger S
影响因子：
120.7
作者：
See, Isaac;Su, John R.;Broder, Karen R.
通讯作者：
Broder, Karen R.
DOI：
10.1056/nejmoa2035389
发表时间：
2021-02-04
期刊：
The New England journal of medicine
影响因子：
--
作者：
Baden LR;El Sahly HM;Essink B;Kotloff K;Frey S;Novak R;Diemert D;Spector SA;Rouphael N;Creech CB;McGettigan J;Khetan S;Segall N;Solis J;Brosz A;Fierro C;Schwartz H;Neuzil K;Corey L;Gilbert P;Janes H;Follmann D;Marovich M;Mascola J;Polakowski L;Ledgerwood J;Graham BS;Bennett H;Pajon R;Knightly C;Leav B;Deng W;Zhou H;Han S;Ivarsson M;Miller J;Zaks T;COVE Study Group
通讯作者：
COVE Study Group