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Rotavirus (RV) is among the most common vaccine-preventable diseases in children under five years of age. Despite the severity of rotavirus pathology in early childhood, rotavirus vaccination for children admitted to the neonatal intensive care unit (NICU), who are often born preterm and with various previous illnesses, is not performed. This multicenter, 3-year project aims to evaluate the safety of RV vaccine administration within the six main neonatal intensive care units of the Sicilian Region to preterm infants. Methods: Monovalent live attenuated anti-RV vaccination (RV1) was administered from April 2018 to December 2019 to preterm infants with gestational age ≥ 28 weeks. Vaccine administrations were performed in both inpatient and outpatient hospital settings as a post-discharge follow-up (NICU setting) starting at 6 weeks of age according to the official immunization schedule. Any adverse events (expected, unexpected, and serious) were monitored from vaccine administration up to 14 days (first assessment) and 28 days (second assessment) after each of the two scheduled vaccine doses. Results: At the end of December 2019, 449 preterm infants were vaccinated with both doses of rotavirus vaccine within the six participating Sicilian NICUs. Mean gestational age in weeks was 33.1 (±3.8 SD) and the first dose of RV vaccine was administered at 55 days (±12.9 SD) on average. The mean weight at the first dose was 3388 (SD ± 903) grams. Only 0.6% and 0.2% of infants reported abdominal colic and fever above 38.5 °C in the 14 days after the first dose, respectively. Overall, 1.9% EAEs were observed at 14 days and 0.4% at 28 days after the first/second dose administration. Conclusions: Data obtained from this study confirm the safety of the monovalent rotavirus vaccine even in preterm infants with gestational age ≥ 28 weeks, presenting an opportunity to improve the vaccination offer both in Sicily and in Italy by protecting the most fragile infants who are more at risk of contracting severe rotavirus gastroenteritis and nosocomial RV infection.

Rotavirus is considered the main cause of severe gastroenteritis and nosocomial infections in Pediatric units, especially during late winter and early spring season in temperate region. In 2013 Sicilian Region, for the first time in Italy, introduced universal Rotavirus vaccination. This study aims to estimate health and economic impact on rotavirus Gastroenteritis (RVGE) among children aged 0–59 months in Sicily, after rotavirus vaccine introduction. We analyzed hospital discharge records including a diagnosis of RVGE occurred from 1st January 2009 to 31st December 2016 among hospitalized children aged 0 to 59 months, residents in Sicily. RVGEs were defined as all hospitalizations with an ICD-9-CM diagnosis code of 008.61 on first or any diagnosis position. Also an economic impact analysis on Health Regional System was conducted. We observed a consistent decline of hospitalization after rotavirus vaccination introduction from 394 per 100,000 in 2009–2012 to 220 per 100,000 in 2013–2016. We found a change in the peak of reported cases by at least one month from March-April in the pre-vaccination period to May-June in the post-vaccination period. Since 2013, we estimated that the annual average cost saved is 1,134,056 € when considering direct and indirect costs to health care as well as vaccination costs. Our study is the first analysis conducted as far as we are aware in a high-income setting with poor coverage (lower than 50%), demonstrating a significant reduction of RVGE hospitalizations in Sicily after vaccine introduction. Moreover, was observed a consistent impact of vaccination on health care cost saving.

Background: Intussusception is the most common cause of bowel obstruction in infants with an incidence ranging from 9-328 cases per 100,000 infants aged 0-11 months. Causes underlining this clinical manifestation are still unknown. Possible relationship with a withdrawn tetravalent rotavirus vaccine was not confirmed by post-licensure studies and actually no increased risk of intussusception was found between infants vaccinated with both the recently licensed rotavirus vaccines. Aim of this study is to analyze the intussusception hospitalizations in Sicily from 2003 to 2012 before the introduction of rotavirus universal vaccination and its possible relation with rotavirus gastroenteritis trend. Methods: Were collected data from hospital discharge records occurred from 1st January 2003 to 31st December 2012 in Sicily. Intussusception cases were defined as all hospitalizations with an ICD-9-CM code of 560.0 on any discharge diagnoses. As a proxy for the severity of cases were considered ICD-9-CM procedure codes accounting for surgical or radiologic reduction. Results: A total of 340 intussusception cases were hospitalized in Sicily from 2003 to 2012 in children aged 0-59 months. 46.8 % occurred in the age class 0-11 months. Hospitalization rate for intussusception was 11.4 cases per 100,000 per year (32.6 cases per 100,000 among 0-11 months children; 7.3 cases per 100,000 among 12-59 months children), with a M:F sex ratio of 1.8. During hospitalization only 25 % of intussusceptions had a spontaneous resolution, 56.5 % of cases required a surgical intervention. From 2003 to 2012 intussusception cases were equally distributed during the year without any seasonality, while gastroenteritis hospitalizations due to rotavirus infection have a typically late winter and spring distribution. Conclusions: In Sicily from 2003 to 2012 hospitalizations due to intestinal invagination were higher among children aged 0-11 months with observed rates similar to other European countries. Regional baseline data analysis of intussusception among 0-59 children is recognized as an evidence-based public health strategy by international health authorities. Indeed, this strategy is necessary to compare any post-licensure age or sex-related change in intussusception trend after universal rotavirus vaccination introduction.