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Sex Differences in Adverse Reactions to an Inactivated SARS-CoV-2 Vaccine Among Medical Staff in China.

ABSTRACT: Objective: We investigated whether there were sex differences in adverse reactions to an inactivated SARS-CoV-2 vaccine among medical staff in China. Methods: From 24 February to 7 March 2021 an online cross-sectional survey was conducted with a self-administered COVID-19 vaccine questionnaire among medical staff in Taizhou, China. In total, 1397 interviewees (1,107 women and 290 men) participated in the survey. Results: In our study, 178 (16.1%) women and 23 (7.9%) men reported adverse reactions following their first vaccination, and 169 (15.3%) women and 35 (12.1%) men reported adverse reactions following their second vaccination. After adjusting for confounding factors, adverse reactions to other vaccines, worry about adverse reactions, knowledge of the inactivated vaccine being used in the hospital, taking the vaccine for one's family proactively and receiving an influenza vaccination were significantly related to adverse reactions to both injections in women. In contrast, in men, concerns about adverse reactions independently increased the risk of adverse reactions following either vaccination, and a history of adverse reactions to other vaccines also increased the risk of adverse reactions to both injections. Conclusions: Sex differences in the frequency of reported adverse reactions to an inactivated SARS-CoV-2 vaccine and potential factors were demonstrated in a sample of medical staff.

SUBMITTER: Zhu JS

PROVIDER: S-EPMC8455952 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background: The outbreak of the novel coronavirus disease COVID-19 caused panic and psychological stress throughout the World. We investigated the extent of adverse psychological reactions in two medical staff groups in China, and explored the importance of online psychological assistance for them. Methods: A cross-sectional online survey including Hospital Anxiety and Depression Scale (HADS) and Insomnia Severity Index (ISI) was utilized to assess anxiety, depression, and insomnia. Propensity score matching (PSM) was applied to match sex and age between the two groups. Differences in the prevalence of adverse psychological reactions between the two groups were compared by a Chi-square test. A multivariate logistic regression analysis was utilized to search for associated adverse psychological reaction factors of two groups. Results: A total of 2,920 medical staff took part in the survey, including 470 frontline and 2,450 non-frontline medical staff. The risk of the frontline group experiencing anxiety, depression, insomnia-early, insomnia-middle, and insomnia-late were 1.16, 1.28, 1.26, 1.22, 1.28 times those of the non-frontline group after PSM. For frontline medical staff, the spinsterhood state (OR = 1.23, 95% CI: 1.00-1.51; P = 0.05) was a risk factor for anxiety. Bachelor or college degree (OR = 2.23, 95% CI: 1.24-4.02, P = 0.01) and a contact history with COVID-19 patients (OR = 1.62, 95% CI: 1.10-2.40; P = 0.02) were risk factors for insomnia. For non-frontline medical staff, being a woman (OR = 1.49, 95% CI: 1.08-2.06, P = 0.01) was a risk factor for anxiety, whilst being in a middle age group was a protective factor for anxiety (OR = 0.70, 95% CI: 0.50-0.99, P = 0.04) and depression (OR = 0.65, 95% CI: 0.45-0.93, P = 0.02). Being a woman (OR = 1.47, 95% CI: 1.14-1.89, P = 0.003) and working in a COVID-19 unit (OR = 1.31, 95% CI: 1.11-1.54, P = 0.001) were risk factors for insomnia, whilst the spinsterhood state (OR = 0.80, 95% CI: 0.67-0.95; P = 0.01) was a protective factor for insomnia. Online forms of psychological aid were all popular with medical staff. Conclusions: The prevalence of anxiety, depression, and insomnia in frontline medical staff was significantly higher than in the non-frontline group. Appropriate intervention methods should be adopted according to the different influencing factors of the two groups. Online psychological aid was the preferred mechanism for relieving psychological problems.

Project description:BackgroundWomen experience adverse drug reactions, ADRs, nearly twice as often as men, yet the role of sex as a biological factor in the generation of ADRs is poorly understood. Most drugs currently in use were approved based on clinical trials conducted on men, so women may be overmedicated. We determined whether sex differences in drug pharmacokinetics, PKs, predict sex differences in ADRs.MethodsSearches of the ISI Web of Science and PubMed databases were conducted with combinations of the terms: drugs, sex or gender, pharmacokinetics, pharmacodynamics, drug safety, drug dose, and adverse drug reaction, which yielded over 5000 articles with considerable overlap. We obtained information from each relevant article on significant sex differences in PK measures, predominantly area under the curve, peak/maximum concentrations, and clearance/elimination rates. ADRs were identified from every relevant article and recorded categorically as female-biased, male-biased, or not sex-biased.ResultsFor most of the FDA-approved drugs examined, elevated blood concentrations and longer elimination times were manifested by women, and these PKs were strongly linked to sex differences in ADRs. Of the 86 drugs evaluated, 76 had higher PK values in women; for 59 drugs with clinically identifiable ADRs, sex-biased PKs predicted the direction of sex-biased ADRs in 88% of cases. Ninety-six percent of drugs with female-biased PK values were associated with a higher incidence of ADRs in women than men, but only 29% of male-biased PKs predicted male-biased ADRs. Accessible PK information is available for only a small fraction of all drugs CONCLUSIONS: Sex differences in pharmacokinetics strongly predict sex-specific ADRs for women but not men. This sex difference was not explained by sex differences in body weight. The absence of sex-stratified PK information in public records for hundreds of drugs raises the concern that sex differences in PK values are widespread and of clinical significance. The common practice of prescribing equal drug doses to women and men neglects sex differences in pharmacokinetics and dimorphisms in body weight, risks overmedication of women, and contributes to female-biased adverse drug reactions. We recommend evidence-based dose reductions for women to counteract this sex bias.

Project description:INTRODUCTION:In general, women more often experience metformin-associated adverse drug reactions (ADRs) than men. OBJECTIVES:We aimed to assess whether sex differences in reported ADRs for metformin are observed at different times after initiation, and to explore their concurrence with sex differences in the dose of metformin over time. This may guide future studies in assessing the involved mechanisms of sex differences in metformin-associated ADRs and may guide sex-specific management of ADRs in clinical practice. METHODS:This study has a longitudinal design using data about patients initiating metformin collected by the Dutch National Pharmacovigilance Center Lareb through their Intensive Monitoring program. Patients were asked to complete a web-based questionnaire six times after initiation (i.e., at 2 weeks, 6 weeks and at 3, 6, 9, and 12 months). The outcome variables were the proportion of patients reporting any ADR (primary) and the dose of metformin (secondary). Sex differences in the proportions of ADRs and in the dose were tested at each assessment using Pearson Chi-Squared tests and Wilcoxon rank-sum tests, respectively. Using Bonferroni adjustment for multiple testing, a p value?<?0.01 was considered statistically significant. RESULTS:The number of included patients was 1712 (40.9% women). Women reported an ADR more often than men, which was statistically significant at the assessment at 2 weeks (34% vs 25%, p?<?0.001), and 6 weeks (37% vs 28%, p?=?0.001) after initiation. In general, women were reported to be prescribed a lower dose than men, which became statistically significant at the 9-month assessment (p?<?0.01). CONCLUSIONS:Sex differences in reported ADRs were seen in the first weeks after metformin initiation, whereas statistically significant differences in self-reported prescribed dosing were observed after several months. Patients, in particular women, might benefit from being prescribed lower metformin doses at treatment initiation.

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Sex Differences in Adverse Reactions to an Inactivated SARS-CoV-2 Vaccine Among Medical Staff in China.

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