Safety of Rotavirus Vaccination in Preterm Infants Admitted in Neonatal Intensive Care Units in Sicily, Italy: A Multicenter Observational Study

Abstract

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.

The Impact of Rotavirus Vaccination on Discharges for Pediatric Gastroenteritis in Italy: An Eleven Year (2009–2019) Nationwide Analysis

“…For example, evidence showed that, despite a significant level of parents’ worries and distress about AGE hospitalization, most of them were unwilling to vaccinate their children [ 41 ]. Among the reported reasons of interest is the fear of side effects such as intussusception, which has been observed in some cases following RV vaccination but whose correlation remains unclear [ 42 , 43 ]. In this regard, extended monitoring and surveillance indicated that RV vaccination seemed not to increase the occurrence of intussusception.…”

Rotavirus Vaccination of Premature Newborns in the NICU: Evaluation of Vaccination Rates and Safety Based on a Single-Centre Study

“…Costantino et al [ 39 ] conducted an observational, descriptive, non-controlled, and non-randomised study in six public hospitals with NICUs. They evaluated the safety of a monovalent rotavirus vaccine (Rotarix) in a group of preterm infants.…”

“…Our study used monovalent and polyvalent rotavirus vaccines because of the Polish health policy and vaccine availability. Costantino et al [ 39 ] used only monovalent vaccines in their trial. Another difference in this study from our analysis was that only 8.1% of vaccinations were initiated in the NICU.…”

Insights and expectations of healthcare professionals on the implementation of the updated pediatric regional immunization Calendar in Calabria, Italy

“…Adherence to the updated co-administration strategy outlined in the CIC could provide many advantages, such as fewer vaccination appointments during the first year of life, completion of the primary vaccination cycle in two sessions (compared with the standard of four), and thereby earlier vaccination, which may provide greater protection against some diseases. 8 , 9 Similar vaccination strategies have also been used previously in the United Kingdom and Portugal. 10 , 11 In the United Kingdom, vaccine co-administration led to no reductions in vaccine coverage or efficacy, and no negative impact on the overall tolerability of the vaccines.…”