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Background More than 10 years after the authorisation of two rotavirus vaccines of demonstrated efficacy and with a strongly positive benefit-risk profile, uptake in Europe remains low. Only 13 countries in Europe provide a fully-funded rotavirus universal mass vaccination (UMV) programme, three provide a partially-funded programme, and one provides full funding for a reduced programme targeting at-risk infants. Around 40% of countries in Europe currently have no existing recommendations for rotavirus vaccine use in children from the national government. Methods We provide an overview of the status of rotavirus vaccine recommendations across Europe and the factors impeding uptake. We consider the evidence for the benefits and risks of vaccination, and argue that cost-effectiveness and cost-saving benefits justify greater access to rotavirus vaccines for infants living in Europe. Results Lack of awareness of the direct and indirect burden caused by rotavirus disease, potential cost-saving from rotavirus vaccination including considerable benefits to children, families and society, and government/insurer cost constraints all contribute to complacency at different levels of health policy in individual countries. Conclusions More than 10 years after their introduction, available data confirm the benefits and acceptable safety profile of infant rotavirus UMV programmes. Europe serves to gain considerably from rotavirus UMV in terms of reductions in healthcare resource utilization and related costs in both vaccinated subjects and their unvaccinated siblings through herd protection. [ABSTRACT FROM AUTHOR]

Objective The multicomponent, recombinant serogroup B vaccine, 4CMenB, is approved in Europe, Canada and Australia from two months of age. We investigated persistence to booster doses at 12 months of age following infant vaccination, and immune response to catch-up vaccination of toddlers and children up to two years of age. Methods We assessed persistence of immune responses after one year in participants vaccinated as infants, and responses to two doses at 12–15 or 24–26 months of age in vaccine-naïve children, as serum bactericidal activity with human complement (hSBA) against indicator strains for four vaccine antigens. Adverse events were recorded after each vaccination. Results High antibody titers were induced against all four 4CMenB components following booster vaccination in infant-primed toddlers and after two doses in previously unvaccinated toddlers or two-year-olds. Antibodies waned over 12 months, particularly those against NZ OMV. Systemic reactogenicity in toddlers was lower than in infants, and lower again in vaccine-naïve two-year-olds. Local reactogenicity was common in all groups. Conclusions Four infant or two toddler 4CMenB vaccinations elicit immune responses believed to be protective for the first two years of life, which can be boosted. Reactogenicity is lower in toddlers than in infants. [ABSTRACT FROM AUTHOR]

Abstract: Austria was the first country in Europe implementing a universal mass vaccination program against rotavirus gastroenteritis (RV-GE) for all infants nationwide. Epidemiological data from a hospital based surveillance system show that incidence rates of children hospitalized with RV-GE decreased in 2009 compared to 2008 and compared to the prevaccination period 2001–2005. Decreasing hospitalization-rates from RV-GE were observed in children of all age groups, even in those not eligible for vaccination according to their age, suggesting herd immunity induced by universal mass vaccination against RV-GE. In 2009 the disease burden was highest in children below three months of age stressing the importance of the early start of the immunization course. [Copyright &y& Elsevier]

Abstract: This study assessed the immunogenicity and safety of a human rotavirus vaccine RIX4414; the effect of co-administration of childhood vaccines on the immune responses was also assessed. Healthy infants aged 6–14 weeks received two doses of RIX4414/placebo concomitantly with the primary childhood vaccination (Infanrix hexa™, Infanrix quinta™, Meningitec™ and/or Prevnar™), respecting the vaccination schedule of each country. Anti-rotavirus IgA seroconversion rate (ELISA cut-off 20U/ml) was measured pre-vaccination and 1–2 months post-Dose 2. Immune response against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, inactivated polio virus, pneumococcal polysaccharide conjugate (France and Germany) and meningococcal group C conjugate vaccines (Spain) were measured approximately 1-month post-Dose 3. An overall anti-rotavirus IgA seroconversion rate of 86.5%(95% CI: 83.9–88.8) was observed in the RIX4414 group 1-month post-Dose 2. The seroconversion rate in Finland and Italy (3 and 5-month schedule) was 94.6%(95% CI: 90.0–97.5) and 92.3%(95% CI: 64.0–99.8), respectively. Immune response to the childhood vaccines was unaffected following co-administration with RIX4414. Reactogenicity profile was similar for RIX4414 and placebo groups. RIX4414 was immunogenic and well tolerated in European infants and the co-administration of routine childhood vaccines with RIX4414 did not negatively impact the immune responses to these vaccines. [Copyright &y& Elsevier]

Rotavirus is the most frequent cause of severe diarrhoea in children aged <5 y. A prospective, multicentre, observational study was conducted in Europe during the 2004–2005 rotavirus season. The study was undertaken in areas of Belgium, France, Germany, Italy, Spain, Sweden, and the UK, to estimate the incidence of community-acquired acute gastroenteritis (AGE) and rotavirus gastroenteritis (RVGE) in children under 5 y of age seeking medical care in 3 settings: primary care, emergency department, and hospital. A post-hoc analysis was done to further describe the age distribution of children with RVGE. The study included 2846 children with AGE. Of 2712 children for whom ELISA results were available, 1102 (40.6%) were rotavirus-positive to the results section well. Overall, 86.1% of RVGE cases occurred in children aged between 3 months and 3 y, whereas 1.8% of cases were observed in infants aged less than 3 months. A total of 3.6% of cases occurred in children aged more than 4 y. These results suggest that, in Europe, routine vaccination for rotavirus should be offered to all infants in early childhood to be effective during the main at-risk period. This could significantly reduce the substantial burden of this potentially serious childhood disease. [ABSTRACT FROM AUTHOR]

Background. The availability of comprehensive, up-to-date epidemiologic data would improve the understanding of the disease burden and clinical consequences of rotavirus gastroenteritis (RVGE) in Europe. Methods. During the 2004-2005 season, a prospective, multicenter, observational study was conducted in children <5 years of age in primary care, emergency department, and hospital settings in selected areas of Belgium, France, Germany, Italy, Spain, Sweden, and the United Kingdom. The clinical consequences of acute gastroenteritis (AGE) and RVGE were estimated. Results. The estimated percentage of children with rotavirus-positive AGE admitted to a hospital was 10.4%-36.0%, compared with 2.1%-23.5% of children with rotavirus-negative AGE. In France, Germany, Italy, Spain, and the United Kingdom, the relative risk of hospitalization was statistically significantly higher for children with rotavirus-positive AGE than for those with rotavirus-negative AGE. Children with rotavirus-positive AGE were more likely to have lethargy, fever, vomiting, and dehydration, and, therefore, more severe disease than were children with rotavirus-negative AGE. Dehydration was up to 5.5 times more likely in children with rotaviruspositive AGE than in those with rotavirus-negative AGE. Conclusions. Rotavirus-positive AGE is more severe, causes more dehydration, and results in more emergency department consultations and hospitalizations than does rotavirus-negative AGE. Variations in the management of RVGE seen across study areas could be explained by differences in health care systems. Routine rotavirus vaccination of infants could significantly reduce the substantial burden of RVGE and would have major benefits for potential patients, their families, and health care providers. [ABSTRACT FROM AUTHOR]

Background: Although vaccination has been proved to be a safe, efficacious, and cost-effective intervention, immunisation rates remain suboptimal in many European countries, resulting in poor control of many vaccine-preventable diseases. Discussion: The Summit of Independent European Vaccination Experts focused on the perception of vaccines and vaccination by the general public and healthcare professionals and discussed ways to improve vaccine uptake in Europe. Despite the substantial impact and importance of the media, healthcare professionals were identified as the main advocates for vaccination and the most important source of information about vaccines for the general public. Healthcare professionals should receive more support for their own education on vaccinology, have rapid access to up-to-date information on vaccines, and have easy access to consultation with experts regarding vaccination-related problems. Vaccine information systems should be set up to facilitate promotion of vaccination. Summary: Every opportunity to administer vaccines should be used, and active reminder systems should be set up. A European vaccine awareness week should be established. [ABSTRACT FROM AUTHOR]