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

Heidari, Shirin; Palmer-Ross, Alice; Goodman, Tracey

doi:10.3390/vaccines9111322

Cited by 45 publications

(54 citation statements)

References 49 publications

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“…In another study of an inactivated virus COVID-19 vaccine (Sinovac COVID- 19), the frequency of adverse events was higher among female medical staff [13]. In a recent study on the 75 clinical trials on different types of COVID-19 vaccines, 24% reported their main results disaggregated by gender, and only 13% mentioned the implications of their study for females and males [14]. In a mini review of studies reporting safety outcomes of COVID-19 vaccines, the authors found a significant lack of gender-disaggregated evidence across studies [15].…”

Section: Introductionmentioning

confidence: 99%

Gender Differences in Adverse Events Following the Pfizer-BioNTech COVID-19 Vaccine

et al. 2022

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Age and gender disaggregated data on reports of adverse events following two or three doses of the Pfizer-BioNTech COVID-19 vaccine were obtained from four cross-sectional studies. The first was from reports submitted to the Israel Ministry of Health national adverse events database (for ages 16 and above). The second was from a national cross-sectional survey based on an internet panel (for ages 30 and above), and the third and fourth were from cross-sectional surveys among employees of a large company (for ages 20–65) using links to a self-completed questionnaire. Results: In all studies, the risks of adverse events were higher following the second dose and consistently higher in females at all ages. The increased risk among females at all ages included local events such as pain at the injection site, systemic events such as fever, and sensory events such as paresthesia in the hands and face. For the combined adverse reactions, for the panel survey the female-to-male risk ratios (RRs) were 1.89 for the first vaccine dose and 1.82 for the second dose. In the cross-sectional workplace studies, the female-to-male RRs for the first, second and third doses exceeded 3.0 for adverse events, such as shivering, muscle pain, fatigue and headaches. Conclusions: The consistent excess in adverse events among females for the mRNA COVID-19 vaccine indicates the need to assess and report vaccine adverse events by gender. Gender differences in adverse events should be taken into account when determining dosing schedules.

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Section: Introductionmentioning

confidence: 99%

Gender Differences in Adverse Events Following the Pfizer-BioNTech COVID-19 Vaccine

et al. 2022

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“…Multivariable logistic regression analysis was performed to identify the factors related to vaccine hesitancy. Variables in the multivariate analysis were selected among factors exhibiting statistical significance in the univariate analysis and factors reported to be associated with vaccine hesitancy: sex, age at enrollment, disease duration, living with older individuals, use of immunomodulators and use of vedolizumab [ 5 , 8 , 9 , 10 , 11 , 12 , 13 , 14 ]. In the multivariable analysis, age (OR: 0.96, 95% CI: 0.92–1.00, p = 0.042) and the use of immunomodulators (OR: 0.08, 95% CI: 0.01–0.66, p = 0.019) was significantly associated with vaccine hesitancy ( Table 2 ).…”

Section: Resultsmentioning

confidence: 99%

“…The questionnaire included questions regarding the patient’s demographic data (sex, age at recruitment, and age at disease diagnosis), epidemiological history of COVID-19, gastrointestinal symptoms, current medication use, history of COVID-19 vaccination, intention to be vaccinated against COVID-19, and reasons for acceptance or refusal of such vaccination ( Table S1 ). Additionally, the questionnaire included questions about factors that have been reported to be associated with COVID-19 vaccination hesitancy, such as cohabitation status, smoking status, and comorbidities [ 5 , 8 , 9 , 10 , 11 , 12 ]. After providing online consent, participants completed several questionnaires using the secure Research Electronic Data Capture (REDCap) platform.…”

Section: Methodsmentioning

confidence: 99%

“…In Japan, 11.0 to 12.3% of the general population are unwilling to be vaccinated [ 6 , 7 , 8 ]. Previous studies have reported that COVID-19 vaccine hesitancy is associated with sex, young age, living alone, low income, presence of severe psychological distress, region, intention to be vaccinated against influenza in the past year, and a low education level [ 5 , 8 , 9 , 10 , 11 , 12 , 13 , 14 ].…”

Section: Introductionmentioning

confidence: 99%

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Acceptance of COVID-19 Vaccines among Patients with Inflammatory Bowel Disease in Japan

Hosomi

Kobayashi

et al. 2021

Healthcare

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Coronavirus disease 2019 (COVID-19) vaccination is recommended for patients with inflammatory bowel disease (IBD). However, the acceptance of COVID-19 vaccines has not been sufficiently evaluated in patients with IBD. We aimed to assess the acceptance and hesitancy of COVID-19 vaccination and related factors among these patients. A retrospective cohort study using a self-reported questionnaire was performed among patients with IBD between 22 June 2021 and 30 August 2021. Of the 187 participants, 10.2% (n = 19) were hesitant to be vaccinated. Patients in the vaccine-hesitant group were younger (p = 0.009) and had a shorter disease duration (p = 0.020). Vedolizumab was prescribed more frequently (p = 0.024) and immunomodulators were less frequently used (p = 0.027) in this group. Multivariable logistic regression analysis identified age (odds ratio [OR]: 0.96, 95% confidence interval [CI]: 0.92–1.00, p = 0.042) and the use of immunomodulators (OR: 0.08, 95% CI: 0.01–0.66, p = 0.019) as independent significant factors for vaccine hesitancy. The COVID-19 vaccine hesitancy rate in patients with IBD in Japan was 10% in this study. The Japanese COVID-19 vaccination campaign appears to be successful. The risk of COVID-19 among patients with IBD requires adequate measures to ensure that vaccines are accepted by vaccine-hesitant patients. These findings may be helpful in achieving adequate vaccination rates.

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“…An overwhelming amount of evidence indicates that COVID-19 has considerable sex and gender disparities in conjunction with infections, hospitalizations, and mortalities [ 76 , 77 ]. Initially, COVID-19 infections were thought to have similar susceptibility to both men and women; however, clinical findings, connecting severity and fatality, are strikingly higher in males than females [ 78 , 79 ], which could be due to distinctions of male vs. female adaptive and innate immune responses, hormonal differences, social/behavioral habits, and comorbidities ( Figure 4 ).…”

Section: Sex and Gender Differences And Their Relevance To Covid-19mentioning

confidence: 99%

Healthy Immunity on Preventive Medicine for Combating COVID-19

2022

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Immunomodulation is influenced by the consumption of nutrients, and healthy immunity is pivotal to defending an individual from a variety of pathogens. The immune system is a network of intricately regulated biological processes that is comprised of many organs, cellular structures, and signaling molecules. A balanced diet, rich in vitamins, minerals, and antioxidants, is key to a strengthened immune system and, thus, crucial to proper functioning of various physiological activities. Conversely, deficiencies of these micronutrients, involving impaired immunity, are linked to numerous health complications, along with a host of pathologies. Coronavirus disease 2019 (COVID-19) is a dangerous infectious disease caused by a β-form of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its genomic variants, which enter host cells upon binding to the angiotensin converting enzyme 2 receptors, and is associated with substantial morbidities and mortalities globally. Patients afflicted with COVID-19 display asymptomatic to severe symptoms, occurrences of which are multifactorial and include diverse immune responses, sex and gender differences, aging, and underlying medical conditions. Geriatric populations, especially men in comparison to women, regardless of their states, are most vulnerable to severe COVID-19-associated infections and complications, with fatal outcomes. Advances in genomic and proteomic technologies help one understand molecular events, including host–pathogen interactions and pathogenesis of COVID-19 and, subsequently, have developed a variety of preventive measures urgently, ranging from mask wearing to vaccination to medication. Despite these approaches, no unique strategy is available today that can effectively prevent and/or treat this hostile disease. As a consequence, the maintenance of a boosted immune system could be considered a high priority of preventive medicine for combating COVID-19. Herein, we discuss the current level of understanding underlining the contribution of healthy immunity and its relevance to COVID-19 molecular pathogenesis, and potential therapeutic strategies, in the management of this devastating disease.

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

Cited by 45 publications

References 49 publications

Gender Differences in Adverse Events Following the Pfizer-BioNTech COVID-19 Vaccine

Gender Differences in Adverse Events Following the Pfizer-BioNTech COVID-19 Vaccine

Acceptance of COVID-19 Vaccines among Patients with Inflammatory Bowel Disease in Japan

Healthy Immunity on Preventive Medicine for Combating COVID-19

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