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

Bignucolo, Alessia; Scarabel, Lucia; Mezzalira, Silvia; Polesel, Jerry; Cecchin, Erika; Toffoli, Giuseppe

doi:10.3390/vaccines9080825

Cited by 72 publications

(69 citation statements)

References 24 publications

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“…In addition, our observations also showed this difference in vaccine response at T2 and T3, in line with a recent meta-analysis [17] Literature reports advise that COVID-19 exhibits differences in morbidity and mortality between gender. Male patients have almost three times the odds of requiring intensive treatment unit admission and higher odds of death compared to females [18].…”

Section: Discussionsupporting

confidence: 92%

Antibody Persistence 6 Months Post-Vaccination with BNT162b2 among Health Care Workers

et al. 2021

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Background: We present immunogenicity data 6 months after the first dose of BNT162b2 in correlation with age, gender, BMI, comorbidities and previous SARS-CoV-2 infection. Methods: An immunogenicity evaluation was carried out among health care workers (HCW) vaccinated at the Istituti Fisioterapici Ospitalieri (IFO). All HCW were asked to be vaccine by the national vaccine campaign at the beginning of 2021. Serum samples were collected on day 1 just prior to the first dose of the vaccine and on day 21 just prior to the second vaccination dose. Thereafter sera samples were collected 28, 49, 84 and 168 days after the first dose of BNT162b2. Quantitative measurement of IgG antibodies against S1/S2 antigens of SARS-CoV-2 was performed with a commercial chemiluminescent immunoassay. Results: Two hundred seventy-four HWCs were analyzed, 175 women (63.9%) and 99 men (36.1%). The maximum antibody geometric mean concentration (AbGMC) was reached at T2 (299.89 AU/mL; 95% CI: 263.53–339.52) with a significant increase compared to baseline (p < 0.0001). Thereafter, a progressive decrease was observed. At T5, a median decrease of 59.6% in COVID-19 negative, and of 67.8% in COVID-19 positive individuals were identified with respect to the highest antibody response. At T1, age and previous COVID-19 were associated with differences in antibody response, while at T2 and T3 differences in immune response were associated with age, gender and previous COVID-19. At T4 and T5, only COVID-19 positive participants demonstrated a greater antibody response, whereas no other variables seemed to influence antibody levels. Conclusions: Overall our study clearly shows antibody persistence at 6 months, albeit with a certain decline. Thus, the use of this vaccine in addressing the COVID-19 pandemic is supported by our results that in turn open debate about the need for further boosts.

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Section: Discussionsupporting

confidence: 92%

Antibody Persistence 6 Months Post-Vaccination with BNT162b2 among Health Care Workers

et al. 2021

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“…Recognizing that subgroup analysis, if not appropriately designed, may not always be feasible it may reveal signals to prompt further investigations. Consistent disaggregation of all data by sex could enable meta-analyses to compare, for example, efficacy or safety of vaccines for women and men, as seen in the meta-analysis by Bignucolo et al [58]. Yet, in our sample, rarely did any study report all data by sex, and only a quarter disaggregated data on at least one outcome by sex.…”

Section: Discussionmentioning

confidence: 89%

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

2021

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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.

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“…Considerations such as these serve to more wholly represent the human population affected by disease and eventual vaccination. These two factors are known to play a significant role in infectious disease pathogenesis ( Bijkerk et al., 2010 ; Ingersoll, 2017 ) and vaccine efficacy ( Lord, 2013 ; Fink et al., 2018 ; Bignucolo et al., 2021 ). Specifically, they appear to influence similar outcomes related to C. burnetii host-pathogen interactions ( Franti et al., 1974 ; Leone et al., 2004 ; Textoris et al., 2010 ).…”

Section: Discussionmentioning

confidence: 99%

Preclinical Animal Models for Q Fever Vaccine Development

Tesfamariam

Binette

Long

2022

Front. Cell. Infect. Microbiol.

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Coxiella burnetii is a zoonotic pathogen responsible for the human disease Q fever. While an inactivated whole cell vaccine exists for this disease, its widespread use is precluded by a post vaccination hypersensitivity response. Efforts for the development of an improved Q fever vaccine are intricately connected to the availability of appropriate animal models of human disease. Accordingly, small mammals and non-human primates have been utilized for vaccine-challenge and post vaccination hypersensitivity modeling. Here, we review the animal models historically utilized in Q fever vaccine development, describe recent advances in this area, discuss the limitations and strengths of these models, and summarize the needs and criteria for future modeling efforts. In summary, while many useful models for Q fever vaccine development exist, there remains room for growth and expansion of these models which will in turn increase our understanding of C. burnetii host interactions.

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

Cited by 72 publications

References 24 publications

Antibody Persistence 6 Months Post-Vaccination with BNT162b2 among Health Care Workers

Antibody Persistence 6 Months Post-Vaccination with BNT162b2 among Health Care Workers

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

Preclinical Animal Models for Q Fever Vaccine Development

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