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

Hum Vaccin Immunother. 2021 Nov 2;17(11):4636-4645. doi: 10.1080/21645515.2021.1955611. Epub 2021 Aug 9.


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.

Keywords: Italy; Rotavirus; epidemiology; impact; safety; vaccination.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Cattle
  • Child
  • Child, Preschool
  • Humans
  • Infant
  • Italy / epidemiology
  • Rotavirus Infections* / epidemiology
  • Rotavirus Infections* / prevention & control
  • Rotavirus Vaccines*
  • Rotavirus*
  • Vaccination
  • Vaccines, Attenuated


  • Rotavirus Vaccines
  • Vaccines, Attenuated

Grants and funding

GlaxoSmithKline Biologicals SA funded this study and was involved in all stages of study conduct, including data analysis. GlaxoSmithKline Biologicals SA also took charge of all costs associated with developing and publishing this manuscript.