Fourteen years’ clinical experience and the first million babies protected with human live-attenuated vaccine against rotavirus disease in Italy

Abstract

Rotavirus (RV) causes up to half of hospital and community acute gastroenteritis (AGE) cases in young children in Italy. Two RV vaccines, available since 2006, are human RV (HRV) and human bovine RV (HBRV). This report looks back at the implementation of RV vaccination with HRV in Italy, and at HRV current and future perspectives. Initial regional policies led to national implementation by 2018, after scientific societies' disease awareness efforts. Following vaccination, RV hospitalizations declined significantly, and cost savings were observed. The two-dose HRV vaccine is easily administered during compulsory vaccine visits, helping increase coverage. Intussusception, a serious event in children <1 year, was reported in Italy with a rate of 33-40 per 100,000 infants. RV vaccination presents a low increased risk of intussusception after the first dose, estimated at 0.6 cases per 100,000 doses in Italy in 2019. Parents should be aware of the intussusception risk and symptoms to ensure prompt treatment. It is widely recognized that the vaccination benefits (large numbers of RV hospitalizations prevented) outweigh the risk. HRV introduction in Italy was supported by epidemiologic burden studies, healthcare provider opinions, and congress debates, which significantly contributed to implementation of RV universal routine infant vaccination in Italy.

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

“…Nevertheless, research into the expanded benefits of RV vaccines on various clinical aspects is an ongoing and active area of study that needs to be increased and reinforced [ 33 ]. Lastly, it should be noted that our results could also have health economic implications: the reduction of AGE hospitalizations observed could represent a proxy for a large health-care cost savings attributable to RV vaccination, which was already found to be a cost-effective strategy from a health payer’s and societal perspective [ 28 ]. Previous economic analyses have shown that, in the absence of vaccination, RVGE would lead to increased healthcare costs and reduced quality of life in patients [ 49 , 50 ].…”

“…Specifically, the results of our study suggest a relationship between the reduction of AGE hospital discharges and the increase in RV vaccination coverage at the national level, as observed in previous regional experiences [ 25 , 26 ]. In Italy, before the introduction of universal RV vaccination in their regional immunization plans in 2017, the regions/AAPPs took different approaches to providing access to RV vaccination, following different regional policies [ 28 ]. Sicily, for example, was the first region to offer universal RV vaccination in 2013, followed by Calabria in 2015; Puglia introduced RV vaccination for all newborns at a discounted co-payment, whereas other regions offered free vaccination to defined categories of infants [ 28 ].…”

“…In Italy, before the introduction of universal RV vaccination in their regional immunization plans in 2017, the regions/AAPPs took different approaches to providing access to RV vaccination, following different regional policies [ 28 ]. Sicily, for example, was the first region to offer universal RV vaccination in 2013, followed by Calabria in 2015; Puglia introduced RV vaccination for all newborns at a discounted co-payment, whereas other regions offered free vaccination to defined categories of infants [ 28 ]. These regional differences could explain the heterogeneous effect of RV vaccination in reducing the AGE hospital discharges that were observed in our study before the introduction of universal RV vaccination.…”

“…At the present time, voluntary vaccination is universally recommended for all children from the sixth week of life, and the vaccination course must be completed no later than 24 or 32 weeks of life, depending on the vaccine used [ 21 , 24 ]. Although the positive impact of vaccination coverage implementation over the years in some Italian regions has been highlighted [ 25 , 26 , 27 , 28 ], an updated national assessment of the vaccination impact on clinical outcomes is still lacking. This study aims to analyze hospital discharges for AGE in children ≤5 years old in Italy before and after the introduction of universal RV vaccination at the regional level in order to assess its impact over the years.…”

Rotavirus and the web: analysis of online conversations in Italy during 2020

“… 4 , 5 Fifteen years after rotavirus vaccines were made available in Italy, more than one million babies have been protected with the two-dose human live-attenuated rotavirus vaccine. 6 Vaccination against rotavirus is included in the vaccination calendar of the National Vaccine Prevention Plan 2017–2019; it is offered free of charge to all newborns in their first year of life (two or three doses, depending on which of the two available vaccines is used). 7 , 8 Rotavirus vaccination is strongly recommended (as is vaccination against Neisseria meningitidis serogroup B and C and pneumococcal disease) but not mandatory.…”