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

被引:61
作者
Bignucolo, Alessia [1 ]
Scarabel, Lucia [1 ]
Mezzalira, Silvia [1 ]
Polesel, Jerry [2 ]
Cecchin, Erika [1 ]
Toffoli, Giuseppe [1 ]
机构
[1] IRCCS, Ctr Riferimento Oncol Aviano CRO, Expt & Clin Pharmacol, Via Franco Gallini 2, I-33081 Aviano, Italy
[2] IRCCS, Ctr Riferimento Oncol Aviano CRO, Unit Canc Epidemiol, Via Franco Gallini 2, I-33081 Aviano, Italy
关键词
SARS-CoV-2; COVID-19; vaccines; sex; gender; immune system; RECURRENT VENOUS THROMBOEMBOLISM; RISK; VACCINATION; RESPONSES;
D O I
10.3390/vaccines9080825
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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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页数:9
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共 26 条
[21]   Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19 [J].
Sadoff, Jerald ;
Gray, Glenda ;
Vandebosch, An ;
Cardenas, Vicky ;
Shukarev, Georgi ;
Grinsztejn, Beatriz ;
Goepfert, Paul A. ;
Truyers, Carla ;
Fennema, Hein ;
Spiessens, Bart ;
Offergeld, Kim ;
Scheper, Gert ;
Taylor, Kimberly L. ;
Robb, Merlin L. ;
Treanor, John ;
Barouch, Dan H. ;
Stoddard, Jeffrey ;
Ryser, Martin F. ;
Marovich, Mary A. ;
Neuzil, Kathleen M. ;
Corey, Lawrence ;
Cauwenberghs, Nancy ;
Tanner, Tamzin ;
Hardt, Karin ;
Ruiz-Guinazu, Javier ;
Le Gars, Mathieu ;
Schuitemaker, Hanneke ;
Van Hoof, Johan ;
Struyf, Frank ;
Douoguih, Macaya .
NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (23) :2187-2201
[22]   Considering how biological sex impacts immune responses and COVID-19 outcomes [J].
Scully, Eileen P. ;
Haverfield, Jenna ;
Ursin, Rebecca L. ;
Tannenbaum, Cara ;
Klein, Sabra L. .
NATURE REVIEWS IMMUNOLOGY, 2020, 20 (07) :442-447
[23]   US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021 [J].
See, Isaac ;
Su, John R. ;
Lale, Allison ;
Woo, Emily Jane ;
Guh, Alice Y. ;
Shimabukuro, Tom T. ;
Streiff, Michael B. ;
Rao, Agam K. ;
Wheeler, Allison P. ;
Beavers, Suzanne F. ;
Durbin, Anna P. ;
Edwards, Kathryn ;
Miller, Elaine ;
Harrington, Theresa A. ;
Mba-Jonas, Adamma ;
Nair, Narayan ;
Nguyen, Duong T. ;
Talaat, Kawsar R. ;
Urrutia, Victor C. ;
Walker, Shannon C. ;
Creech, C. Buddy ;
Clark, Thomas A. ;
DeStefano, Frank ;
Broder, Karen R. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2021, 325 (24) :2448-2456
[24]   Sex-disaggregated data in COVID-19 vaccine trials [J].
Vijayasingham, Lavanya ;
Bischof, Evelyne ;
Wolfe, Jeannette .
LANCET, 2021, 397 (10278) :966-967
[25]   Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century [J].
Watson, Sarah ;
Caster, Ola ;
Rochon, Paula A. ;
Ruijter, Hester den .
ECLINICALMEDICINE, 2019, 17
[26]   Sex Differences in Reported Adverse Drug Reactions to COVID-19 Drugs in a Global Database of Individual Case Safety Reports [J].
Zekarias, Alem ;
Watson, Sarah ;
Vidlin, Sara Hedfors ;
Grundmark, Birgitta .
DRUG SAFETY, 2020, 43 (12) :1309-1314