Although the safety profiles of mRNA COVID-19 vaccines (mRNA-1273 and BNT162b2) were evaluated in pre-authorization clinical trials, real-world data allow us to better define their benefit/risk ratio in the paediatric population. The current study aimed to evaluate the safety profiles of mRNA COVID-19 vaccines in children by analysing the pharmacovigilance data of the European spontaneous reporting system database EudraVigilance (EV) in the period from 1 January 2021, to 1 October 2022. During our study period, overall 4838 ICSRs related to mRNA COVID-19 vaccines referring to 5–11-year-old subjects were retrieved from EV, of which 96.9% were related to BNT162b2 and 49.3% were related to males. A total of 12,751 Adverse Events Following Immunization (AEFIs) were identified, of which 38.7% were serious. The most frequently reported AEFIs were pyrexia, headache, and vomiting. Only 20 Individual Case Safety Reports (ICSRs) reported Multisystem Inflammatory Syndrome (MIS) as an AEFI, all related to BNT162b2. The majority of MIS cases were females, and six cases were completely resolved at the time of reporting. Our results show a favourable risk–benefit profile for all mRNA COVID-19 vaccines in this paediatric sub-population, supporting their use in children. Considering the peculiarity and fragility of children, continuous safety monitoring of COVID-19 vaccines is required.

Background: The national lockdown and the different restrictions applied in 2020 during the COVID-19 pandemic brought several changes to hospitalization procedures. The aim of this study was to evaluate the patterns in access to emergency services and hospitalization in a tertiary-care obstetric and gynecological emergency department (OG-ED) throughout the restrictions applied during 2020. Methods: A single-center retrospective comparative study on data from January to December 2020 was carried out on the following timeframes: January to February 2020 (before COVID-19 pandemic), March to June 2020 (nationwide lockdown period), July to September 2020 (removal of restrictive measures), October to December 2020 (regional lockdown) and compared to the same periods of 2019. All obstetric and gynecological patients with complete medical data admitted to the OG-ED were included. Results: Overall, 4233 accesses for 2019 and 3652 for 2020 were reported, with a decreasing trend of −13.7%. Between March and June 2020 (nationwide lockdown) and 2019, the overall number of patients attending the OG-ED decreased compared to July–September and October–December differences (Δ −23.5% vs. −3.1% and −5.9%; p = 0.001 respectively) for 2020–2019, but this reduction was not statistically significant when compared to January–February (Δ −23.5% vs. −18.5%; p = 0.356). No significant differences for obstetric patients (Δ −1.8% vs. −1.0% vs. −2.3% and +1.9% respectively; p = 0.883) were noted. Hospitalizations showed a stable trend with an increase between October–December 2019 and 2020 (Δ +4.6%; p = 0.001 vs. January–February (+2.4%) and March–June (+2.6%) 2019–2020), mainly related to regional lockdowns. Conclusions: In contrast to available national studies, in our institution, the overall rate of OG-ED admissions was slightly reduced with a similar trend of decrease even before COVID-19, with an increase in admissions for serious issues, despite expectations that the suspension of elective admissions and outpatient services would have led to an increase in non-urgent hospitalizations during the COVID-19 lockdown period.

Vaccinations are a cornerstone of primary prevention in pediatric otolaryngology and play a critical role in reducing the burden of pediatric infectious diseases, particularly acute otitis media (AOM) and HPV-related infections. The introduction and widespread use of pneumococcal conjugate vaccines (PCVs) have been associated with substantial changes in the epidemiology of pediatric AOM, particularly through reductions in vac-cine-serotype disease and complicated forms, while contributing to changes in pathogen distribution with an increased role of non-vaccine serotypes and non-pneumococcal bac-teria, requiring continuous epidemiological surveillance. Prophylactic human papillomavirus (HPV) vaccination in adolescents and young adults effectively prevents oral infection with vaccine-type high-risk HPV, a necessary step in the pathogenesis of HPV-related oropharyngeal carcinoma. Clinical and epidemiological studies demonstrate robust antibody responses and significant reductions in oral HPV prevalence among vaccinated individuals. Although direct evidence of a reduction in oropharyngeal cancer incidence is not yet available, vaccination may consequently reduce the future burden of HPV-related oropharyngeal cancers. Long-term surveillance remains essential to confirm this potential benefit. Barriers to optimal vaccine coverage include unequal access, incomplete vaccination uptake, and limited awareness of HPV-related oral disease. In conclusion, vaccinations provide direct and clinically relevant benefits in pediatric otolaryngology by reducing recurrent AOM, severe complications and surgical interventions. HPV vaccination also reduces vaccine-type oral HPV infection and may consequently contribute to reducing the future burden of HPV-related oropharyngeal cancers. Achieving high vaccination coverage, coupled with continuous epidemiological monitoring, is essential to maximize individual and public health benefits and to inform the development of vaccines with broader serotype coverage.