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Following the licensure of two rotavirus vaccines in Europe, we aimed to assess factors, such as surveillance, disease burden and laboratory capacity, which will be relevant for making decisions about rotavirus vaccine introduction in the different countries. We conducted an email-based survey of the national public health bodies in the World Health Organization (WHO) European Region in 2006 and report here the results from the 23 countries in the eastern part of the region. The survey included questions on rotavirus surveillance, laboratory capacity, burden (in children under the age of five years) and intention to introduce rotavirus vaccination. Countries were grouped into the four per-capita income categories defined by the World Bank. Fourteen of the 23 countries responded to the survey. All except one country reported that less than a quarter of their laboratories had rotavirus diagnostic capacity. Four countries had some form of specific rotavirus surveillance, but half were of very limited coverage. Ten countries did not report data on the incidence of rotavirus hospital admissions, although nine were able to report some data on rotavirus burden. Six of the responding countries said they were likely to introduce universal rotavirus vaccination. Rotavirus surveillance and laboratory capacity in the eastern part of the WHO European Region is limited but most countries had some estimate of rotavirus burden, often from special studies. The reported mortality rates were lower than those from a WHO mortality data source. Many countries in the eastern part of WHO European Region face a number of challenges before vaccine implementation, including strengthening surveillance, improving laboratory capacity and addressing financial barriers.

Background: We aimed to assess the efficacy of the oral live attenuated human rotavirus vaccine Rotarix (RIX4414) for prevention of rotavirus gastroenteritis in European infants during their first 2 years of life., Methods: 3994 study participants were enrolled from six countries and were randomly assigned two oral doses of either RIX4414 (n=2646) or placebo (n=1348), which were coadministered with the first two doses of specific childhood vaccinations. Follow-up for gastroenteritis episodes was undertaken from 2 weeks post-dose two through the two consecutive rotavirus seasons following vaccinations (combined efficacy follow-up period; mean duration 17 months [SD 1.6]). Our primary endpoint was vaccine efficacy against rotavirus gastroenteritis of any severity during the first efficacy follow-up period (2 weeks post-dose two to the end of the first rotavirus season). Stool specimens obtained during gastroenteritis episodes were tested for rotavirus by ELISA and typed by RT-PCR. Episodes scoring 11 or greater on the 20-point Vesikari scale were classified as severe. Analysis was according to protocol. This study is registered with ClinicalTrials.gov, number NCT00140686 (eTrack102247)., Findings: 120 infants were excluded from the according-to-protocol analysis. During the first efficacy follow-up period (mean duration 5.7 months [SD 1.2]), 24 of 2572 infants allocated RIX4414 versus 94 of 1302 given placebo had rotavirus gastroenteritis episodes of any severity, resulting in a vaccine efficacy of 87.1% (95% CI 79.6-92.1; p<0.0001). For the combined efficacy follow-up period, vaccine efficacy against severe rotavirus gastroenteritis was 90.4% (85.1-94.1; p<0.0001), for admission owing to rotavirus gastroenteritis 96.0% (83.8-99.5; p<0.0001), and for rotavirus-related medical attention 83.8% (76.8-88.9; p<0.0001), and significant protection against severe rotavirus gastroenteritis by circulating G1, G2, G3, G4, and G9 rotavirus types was shown., Interpretation: In a European setting, two doses of RIX4414 coadministered with childhood vaccines provided high protection against any and severe rotavirus gastroenteritis, with an overall reduction of admissions for gastroenteritis over two consecutive rotavirus epidemic seasons.

The degree of diversity of cocirculating human rotavirus wild-type strains is high. This article reviews the occurrence and frequency of rotavirus types in European children younger than 5 years of age during the past 10-15 years. To enable greater understanding of the overall epidemiologic situation, rotavirus types found in animals in Europe are described. In addition, rotavirus types occurring in children outside Europe are considered. Taken together, these data provide an essential background to the development of rotavirus vaccines. The different concepts of immunization with the 2 main rotavirus candidate vaccines are briefly discussed, and their potential impact on the epidemiology of cocirculating rotavirus wild-type viruses is considered. A case is made for comprehensive surveillance of cocirculating human rotavirus types in Europe after the implementation of rotavirus vaccination.