Abstract

Rotavirus (RV) is the leading cause of severe diarrhoea in children, annually causing >500,000 diarrhoea-related deaths in children aged < 5 years worldwide.1 Since young infants can acquire the infection, there is a need for early protection.2 In addition to the substantial burden of mortality (especially in developing countries) RV gastroenteritis (RVGE) has a considerable impact on the morbidity and quality of life of both affected children and their parents in Europe.3The RV1/monovalent vaccine is an oral G1P[8], live-attenuated human rotavirus vaccine. RV1 has a two-dose schedule that can be completed by 10 weeks of age and offers early protection against circulating RV strains. The vaccine has demonstrated efficacy against severe RVGE (90.4% [95%CI: 85.1-94.1]).4,5 Heterotypic cross-protection is the mechanism underlying the efficacy of RV1 in non-vaccine strains (79.2% [95%CI:8.9-96.5]); including the fully heterotypic G2P[4] strain.6 In trials and post-marketing surveillance (including 69 million doses), RV1 has demonstrated a clinically acceptable safety profile and has been generally well tolerated in healthy infants; furthermore, studies have shown no specific safety issues in high risk populations such as HIV-positive and pre-term infants.4,7,8Routine RV vaccination - mainly with RV1 - was implemented in Belgium in 2006, which resulted in a 53% decrease in peak incidence by 2007, with the highest decline in children aged < 1 years (81% reduction).9 In Austria, a 74% decrease in hospitalisation rates due to RVGE was observed compared to the era before the introduction of the vaccine.10 Similar trends were also observed in US with the RV5/pentavalent bovine-human reassortant vaccine.11 New data from EuroRotaNet show the dynamic nature of rotavirus infection with the emergence of G8 and G12 strains.12,13Widespread implementation of RV vaccination would effectively reduce the European burden of RVGE and support the WHO recommendation for its inclusion into national immunisation programmes in countries that can afford the vaccine.14

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