BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in Italy.

Millions of people have died because of the COVID-19 pandemic. The vaccination campaign helped tackle the pandemic and saved millions of lives. In a retrospective pharmacovigilance study, we explored the safety of the BNT162b2 (Comirnaty) vaccine among healthcare workers (HCWs) in a large Italian teaching hospital, and 2428 Adverse Events Reports (AERs) filed by HCWs after the administration of the first dose of vaccine were collected and analyzed, reporting the results quantitively and comparing them to the vaccine Summary of Product Characteristics (SPC). Spearman's correlation coefficients were computed to investigate the correlation among reported adverse effects, and recurrent clusters of symptoms were investigated through the Principal Component Analysis (PCA) and k-means Cluster Analysis. The BNT162b2 vaccine's safety profile was favorable, with predominant reports of early onset, mild, non-serious and short-term resolved symptoms. We observed higher than the expected frequency for various non-serious undesirable effects, especially among those listed and classified as less common in the SPC. Furthermore, we identified three clusters of adverse effects that were frequently reported together, defined by the presence/absence of fatigue, malaise, localized pain, chills, pyrexia, insomnia, nausea and injection site pain. Post-marketing pharmacovigilance activities, together with targeted public health interventions, can be valuable tools to promote vaccination and improve the control of the spread of the pandemic, especially in sensitive settings and populations such as hospitals and healthcare professionals.

Risk of Infection and Duration of Protection after the Booster Dose of the Anti-SARS-CoV-2 Vaccine BNT162b2 among Healthcare Workers in a Large Teaching Hospital in Italy: Results of an Observational Study.

The efficacy of the first schedule of COVID-19 mRNA vaccines has decreased after the surge of the Delta variant, posing the need to administer a booster dose to enhance the neutralising immune response. This study aims at evaluating the duration of protection given by the booster dose of Pfizer-BioNTech BNT162b2 mRNA vaccine in healthcare workers (HCWs) of a large teaching hospital in Rome and to analyse the factors associated with post-booster vaccination infections. Data about vaccinations of HCWs with the BNT162b2 vaccine and nasal swabs positive for SARS-CoV-2 were extracted from the digital archives of the hospital from 27 September 2021 to 31 May 2022. In total, 5770 HCWs were observed. The cumulative risk of becoming infected by SARS-CoV-2 increased with time (2.5% at 4 weeks, 17% at 12 weeks and 40% at 24 weeks) and was significantly higher for females, younger classes of patients and for those who had developed a hybrid immunity (natural infection plus one dose, namely the primary schedule, added to the booster dose) compared to those who had completed the three doses. This study describes the duration and the determinants of the protection against infections after the booster dose of COVID-19 vaccine, highlighting the need for continuous monitoring of vaccine-induced immunogenicity.

A real opportunity to modify cardiovascular risk through primary care and prevention: A pilot study.

Cardiovascular diseases (CVDs) represent a major threat to health and primary prevention outstands as the most effective instrument to face this issue, addressing multiple risk factors at a time and influencing behavioral patterns. Community nurses have been involved in many interdisciplinary prevention activities, resulting in effective control of CV risk factors. We conducted a pilot study aiming at describing the impact on the CV risk profile of an 18-month interdisciplinary intervention on lifestyle habits. From September 2018 to May 2020, four general practitioners (GPs) working in the Roman neighborhood of Torresina recruited patients having a cardiovascular risk score (CRS) equal to or higher than 3% and lower than 20%; those patients were included in a nutritional, physical, and psychological counseling program. Assessments of patients' health status were led at baseline, 6, 12, and 18 months by a nutritionist, a physiotherapist, a psychologist, their GPs, and a community nurse. The CRS was estimated at every examination, based on the Italian Progetto Cuore algorithm. A total of 76 patients were included (mean age of 54.6 years; 33 men and 43 women). Mean CRS showed a significant reduction between baseline and 12 months (from 4.9 to 3.8); both total cholesterol and systolic blood pressure (SBP) significantly decreased at 6 months of follow-up (respectively, from 211.1 to 192 and from 133.1 to 123.1). Nonetheless, the reduction was later maintained only for SBP. However, during the last 6 months of the intervention, the COVID-19 pandemic broke out, thus, it is not possible to know how much the results achieved at 18 months were influenced by the restrictive measures introduced by the Italian government. When stratifying according to the presence of hypertension/diabetes and physical activity, no differences in the CRS could be highlighted between the two groups. Our pilot study proved that an interdisciplinary counseling intervention program can improve CV risk profile and could be further spread to people that, according to their CRS, would benefit more from changes in lifestyles.

A real opportunity to modify cardiovascular risk through primary care and prevention: A pilot study

Cardiovascular diseases (CVDs) represent a major threat to health and primary prevention outstands as the most effective instrument to face this issue, addressing multiple risk factors at a time and influencing behavioral patterns. Community nurses have been involved in many interdisciplinary prevention activities, resulting in effective control of CV risk factors. We conducted a pilot study aiming at describing the impact on the CV risk profile of an 18-month interdisciplinary intervention on lifestyle habits. From September 2018 to May 2020, four general practitioners (GPs) working in the Roman neighborhood of Torresina recruited patients having a cardiovascular risk score (CRS) equal to or higher than 3% and lower than 20%;those patients were included in a nutritional, physical, and psychological counseling program. Assessments of patients' health status were led at baseline, 6, 12, and 18 months by a nutritionist, a physiotherapist, a psychologist, their GPs, and a community nurse. The CRS was estimated at every examination, based on the Italian Progetto Cuore algorithm. A total of 76 patients were included (mean age of 54.6 years;33 men and 43 women). Mean CRS showed a significant reduction between baseline and 12 months (from 4.9 to 3.8);both total cholesterol and systolic blood pressure (SBP) significantly decreased at 6 months of follow-up (respectively, from 211.1 to 192 and from 133.1 to 123.1). Nonetheless, the reduction was later maintained only for SBP. However, during the last 6 months of the intervention, the COVID-19 pandemic broke out, thus, it is not possible to know how much the results achieved at 18 months were influenced by the restrictive measures introduced by the Italian government. When stratifying according to the presence of hypertension/diabetes and physical activity, no differences in the CRS could be highlighted between the two groups. Our pilot study proved that an interdisciplinary counseling intervention program can improve CV risk profile and could be further spread to people that, according to their CRS, would benefit more from changes in lifestyles.

Medical Residents' Behaviours toward Compulsory COVID-19 Vaccination in a Tertiary Hospital in Italy.

To maintain safety conditions in the provision of care and assistance, and to protect healthcare workers (HCWs) and patients, the Italian government required compulsory COVID-19 vaccination for HCWs, including medical residents (MRs). The aim of this study was to assess COVID-19 vaccination coverage in MRs in a large tertiary hospital in Italy, before and after the introduction of compulsory vaccination, according to demographic characteristics and specific residency. A database on COVID-19 vaccination status and infection of resident medical doctors was created. Descriptive statistics and logistic regressions were carried out on the data. A total of 1894 MRs were included in the study. Being vaccinated in the same hospital as the residency program was significantly related to the year of residency and being enrolled in a frontline residency. A significant association between compliance with the compulsory primary cycle vaccination and vaccination in the hospital residency was observed. Being enrolled in the second, third, and last years of residency, and in a frontline residency, were predictive of being vaccinated in the residency hospital. Almost 100% of the MRs participating in the study were vaccinated against COVID-19. Compulsory vaccination of HCWs, alongside greater and clearer information about the risks and benefits of vaccination, represents an important booster to ensure public health and to promote quality and safety of care.

Factors Influencing the Choice to Advise for or against COVID-19 Vaccination in the Physicians and Dentists of an Italian Region.

Healthcare workers (HCWs), particularly physicians, are a relevant and trusted source of information for patients, especially when health-related choices such as vaccination are concerned. Between July and November 2022, we administered a web-based survey to physicians and dentists living in the Latio region of Italy to explore whether their background might affect their willingness to recommend the COVID-19 vaccination to their patients (RCVtoPat) and their relatives (RCVtoRel). We performed a multivariable logistic regression to study the association between the two outcomes (RCVtoPat and RCVtoRel) and their potential determinants in our sample (n = 1464). We found that being a dentist, an increasing fear of COVID-19, and having been previously vaccinated against flu are positively associated with both RCVtoPat and RCVtoRel, while a better self-rated knowledge of COVID-19 vaccines is associated only with RCVtoRel. No role was found for age, sex, civil status, education level, information sources, previous SARS-CoV-2 infection, and chronic diseases. A sub-group analysis of physicians alone (n = 1305) demonstrated a positive association with RCVtoRel of being specialized in diagnostic/therapeutic services and a negative effect on RCVtoPat of being trained in general practice. We provide useful insights about the factors that should be addressed to ensure HCWs exert a positive influence on their patients and communities.

Knowledge, attitudes, and behaviors toward COVID-19 vaccination in a sample of Italian healthcare workers.

Vaccine hesitancy in healthcare workers (HCWs) has been studied for various contagious diseases, but there is still insufficient knowledge about this phenomenon for COVID-19. We developed and validated a knowledge, attitude, and practice survey of 39 questions to assess Italian HCWs' hesitancy toward vaccination in general (general hesitancy), COVID-19 vaccination (COVID-19 hesitancy), and public health injunctive measures (refusal of obligations). The survey was administered through a web platform between July and November 2021. Three multivariable logistic regressions were performed to evaluate the association between the explored dimensions of hesitancy and the potential determinants investigated. Out of 2,132 respondents with complete answers, 17.0% showed to be generally hesitancy toward vaccination, 32.3% were hesitant on COVID-19 vaccination, while 18.8% were categorized as refusing obligations. A significant protective effect against all three dimensions of hesitancy was found for increasing fear of COVID-19, advising COVID-19 vaccination to relatives and patients, having received flu vaccination in the previous year and having higher levels of education. Better self-rated knowledge about COVID-19 vaccines and reading up institutional sources were significantly protective against general and COVID-19 hesitancy, while being a physician rather than another healthcare professional was protective only against COVID-19 hesitancy. Conversely, increasing age and referring to colleagues to expand knowledge about COVID-19 were positively associated with COVID-19 hesitancy. The determinants of general hesitancy, COVID-19 hesitancy and the refusal of obligations are mostly overlapping. Given the great influence they exert on patients and communities, it is pivotal to limit HCWs vaccine hesitancy through appropriate training activities.

Flu and COVID-19 Vaccination: What Happens to the Flu Shot When the Campaigns Overlap? Experience from a Large Italian Research Hospital.

Influenza represents a threat to global health and health care workers (HCWs) have an increased risk of contracting the influenza virus in the workplace. The COVID-19 pandemic has brought back the importance of influenza vaccination, as the influenza virus can circulate together with SARS-CoV-2. The aim of this report is to describe the actual flu vaccination coverage among healthcare workers of a research hospital and the trend changes, with respect to the past flu vaccination campaigns, in light of the present pandemic and COVID-19 vaccination. A Pearson's χ2 test was used to test the correlation of flu vaccination coverage, across all professional categories, between the last two years. A linear regression model was adopted to predict the total vaccination coverage of this year. A statistically significant decrease (p < 0.01) was observed in vaccination coverage among all the professional categories with a 50% reduction in vaccination trends between the last two years. Analyzing the data from the previous six flu vaccination campaigns, the expected value, according to the linear regression model, was estimated to be 38.5% while the observed value was 24%. The decrease in vaccination coverage may be due to the fear of the pandemic situation and especially to the uncertainty related to the consequences of a concurrent administration which may overload the immune system or may be more reactogenic. The COVID-19 pandemic represents an opportunity to promote and support large-scale influenza vaccination among HCWs through structured programs, adequate funding, and tailored communication strategies.

Hormones and Sex-Specific Medicine in Human Physiopathology.

A prodigious increment of scientific evidence in both preclinical and clinical studies is narrowing a major gap in knowledge regarding sex-specific biological responses observed in numerous branches of clinical practices. Some paradigmatic examples include neurodegenerative and mental disorders, immune-related disorders such as pathogenic infections and autoimmune diseases, oncologic conditions, and cardiovascular morbidities. The male-to-female proportion in a population is expressed as sex ratio and varies eminently with respect to the pathophysiology, natural history, incidence, prevalence, and mortality rates. The factors that determine this scenario incorporate both sex-associated biological differences and gender-dependent sociocultural issues. A broad narrative review focused on the current knowledge about the role of hormone regulation in gender medicine and gender peculiarities across key clinical areas is provided. Sex differences in immune response, cardiovascular diseases, neurological disorders, cancer, and COVID-19 are some of the hints reported. Moreover, gender implications in occupational health and health policy are offered to support the need for more personalized clinical medicine and public health approaches to achieve an ameliorated quality of life of patients and better outcomes in population health.