The Interplay of Perceived Risks and Benefits in Deciding to Become Vaccinated against COVID-19 While Pregnant or Breastfeeding: A Cross-Sectional Study in Italy.

The present study examined the role of the perception of risks and benefits for the mother and her babies in deciding about the COVID-19 vaccination. In this cross-sectional study, five hypotheses were tested using data from a convenience sample of Italian pregnant and/or breastfeeding women (N = 1104, July-September 2021). A logistic regression model estimated the influence of the predictors on the reported behavior, and a beta regression model was used to evaluate which factors influenced the willingness to become vaccinated among unvaccinated women. The COVID-19 vaccination overall risks/benefits tradeoff was highly predictive of both behavior and intention. Ceteris paribus, an increase in the perception of risks for the baby weighed more against vaccination than a similar increase in the perception of risks for the mother. Additionally, pregnant women resulted in being less likely (or willing) to be vaccinated in their status than breastfeeding women, but they were equally accepting of vaccination if they were not pregnant. COVID-19 risk perception predicted intention to become vaccinated, but not behavior. In conclusion, the overall risks/benefits tradeoff is key in predicting vaccination behavior and intention, but the concerns for the baby weigh more than those for the mother in the decision, shedding light on this previously neglected aspect.

Acute appendicitis in a patient immunised with COVID-19 vaccine: A case report with morphological analysis.

Although the benefit/risk profile for mRNA COVID-19 vaccines is recognised as extremely favourable, appendicitis is currently considered an adverse event (AE) of special interest. We describe the case of a 58-year-old female who presented with signs and symptoms of appendicitis approximately 48 hours after her first injection of the Pfizer-BioNTech vaccine. Abdominal ultrasound revealed fluid collection in the right iliac fossa and cecal wall thickening. Following the surgical visit, CT scan with contrast showed a distended appendix with thickened walls, suggestive of acute appendicitis. The patient tested negative to upper respiratory COVID-19 reverse transcription-polymerase chain reaction. Clinical trials and observational studies suggest a possible association between appendicitis and COVID-19 vaccines. Th-1 driven granulomatous inflammation reported in our case represents an infrequent nonspecific chronic inflammation of the appendix, especially in the setting of delayed or interval appendectomy. In view of the current paediatric vaccination campaign, we recommend monitoring the safety profile and potential gastrointestinal AEs associated with mRNA COVID-19 vaccines to swiftly manage subjects with gastrointestinal symptoms and prevent potential complications.

Exclusive breastfeeding and women's psychological well-being during the first wave of COVID-19 pandemic in Italy.

Background: At the onset of the COVID-19 pandemic, support for breastfeeding was disrupted in many countries. Italy was severely impacted by the pandemic and is known to have the lowest exclusive breastfeeding rate of all European countries. Considering the inverse association between anxiety and breastfeeding, maternal concerns about the COVID-19 emergency could reduce breastfeeding rates. The aim of the study is to explore the association between infant feeding practices and maternal COVID-19 concerns. Methods: This paper is a secondary analysis of the cross-sectional study COVID-ASSESS conducted in Italy in 2020. The original survey was administered in two phases: during the first lockdown and during the reopening. The survey included five sections: socio-demographic, medical history, concerns about the COVID-19 pandemic, infant feeding practices and psychometric evaluation. Participants were considered eligible for the post-hoc analyses if they were exclusively breastfeeding or they were feeding with infant formula (either alone or with breastfeeding) at the time of the interview. Results: Between phase 1 and phase 2 there was a decrease in anxiety and concerns about the danger of COVID-19 to general health, except for concerns about their baby's health. Women using formula were more concerned about all the health topics investigated. Moreover, they showed higher levels of stress, state anxiety, somatization and PTSD symptoms. Conclusion: Breastfeeding during the first pandemic lockdown in Italy seems to have been an independent factor associated with lower anxiety about COVID-19, fewer psychopathological symptoms, and a positive experience of infant feeding.

Pharmacovigilance and Pharmacoepidemiology as a Guarantee of Patient Safety: The Role of the Clinical Pharmacologist

Recent years, particularly the COVID-19 pandemic, can be considered a turning point for pharmacovigilance and pharmacoepidemiology in terms of their role in drug safety and drug utilisation monitoring in clinical practice [...]

Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug-drug interactions.

Due to the need of early and emergency effective treatments for COVID-19, less attention may have been paid to their safety during the global emergency. In addition, characteristics of drug-drug interaction (DDI)-related adverse drug reactions (ADRs) in COVID-19 patients have not yet been studied in depth. The aim of the present case-series study is to describe clinical and pharmacological characteristics of SARS-CoV-2 hospitalised patients, focusing on ADRs, particularly those related to DDIs. We evaluated all reports of COVID-19 medication-related ADRs collected within the COVID-19 Units of Careggi University Hospital, Florence (Italy), between January 1st and 31st May 2020. Information regarding COVID-19 medications, patients' demographic and clinical characteristics, concomitant drugs, ADRs description and outcome, were collected. Each case was evaluated for the causality assessment and to identify the presence of DDIs. During the study period, 23 Caucasian patients (56.5% males, mean age 76.1 years) experienced one or more ADRs. The majority of them were exposed to polypharmacy and 17.4% presented comorbidities. ADRs were referred to cardiovascular, psychiatric and gastrointestinal disorders. The most frequently reported preferred term was QT prolongation (mean QT interval 496.1 ms). ADRs improved or resolved completely in 60.8% of cases. For all patients, a case-by-case evaluation revealed the presence of one or more DDIs, especially those related to pharmacokinetic interactions. Despite the small number of patients, our evidence underline the clinical burden of DDIs in SARS-CoV-2 hospitalised patients and the risk of unexpected and uncommon psychiatric ADRs.