Rotavirus Vaccines In Europe Research Articles

The Value of Rotavirus Vaccination in Europe: A Call for Action.

The severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) pandemic has pushed many healthcare systems into crisis. High vaccine coverage amongst children reduces emergency room presentations, hospital admissions and deaths due to vaccine-preventable diseases, freeing up healthcare resources including polymerase chain reaction testing for patients with SARS-CoV-2. In Europe, rotavirus gastroenteritis leads to 75,000-150,000 hospitalisations and up to 600,000 medical encounters annually. Nevertheless, in 2022, only 18 countries in Europe (out of 38) have a publicly funded routine universal mass immunisation programme against rotavirus gastroenteritis. Evidence available in the last few years re-emphasises that rotavirus vaccines currently available in Europe are highly effective, preventing up to 96% of rotavirus-related hospitalisations in children less than 1year of age (potentially 72,000-144,000 hospitalisations Europe-wide). Long-term surveillance indicates that rotavirus vaccination does not result in an overall increase in intussusception. On the contrary, increasing evidence suggests an overall reduction in intussusception in the first 12months of life when early, high rotavirus vaccine coverage is achieved. Prevention of rotavirus gastroenteritis has marked positive impacts on parental wages and government tax revenue, with benefits extending across the whole economy. In the SARS-CoV-2 pandemic setting there is a new imperative to achieve high levels of paediatric vaccination against vaccine-preventable diseases, including rotavirus gastroenteritis. The introduction of rotavirus universal mass vaccination can be expected to reduce the number of preventable illnesses, hospitalisations and deaths caused by rotavirus gastroenteritis. Reducing vaccine-preventable diseases is particularly urgent at this time when healthcare systems are preoccupied and overwhelmed with SARS-CoV-2. Graphical abstract available for this article.

PIN115 - BARRIERS TO ACCESS AND IMPLEMENTATION OF ROTAVIRUS VACCINATION IN EUROPE

Rotavirus (RV) is a major agent of gastroenteritis and an important cause of child death worldwide. Immunization has been available since 2006. (1) Twelve years after the authorization of two rotavirus vaccines of demonstrated efficacy and with a strongly positive benefit-risk profile, implementation in Europe remains low. The aim of this study is to review existing barriers to access and implementation of RV vaccination in Europe. A literature search using online electronic databases was conducted to collect information on national and local recommendations, costs and perception of barriers for implementation of RV vaccination in Europe. Relevant scientific articles published between 2010 and 2018 were included in the review. Some key factors have been identified as existing barriers to vaccine access and implementation. The direct and indirect costs for vaccination and the limited perception of RV severity by the families are two major barriers for large-scale implementation of RV vaccination programs in Europe. Insufficient information and lack of public awareness on the benefits of RV vaccination may lead to negative perceptions among the general public. However, some authorities may restrict access due to the wrong perception of disease burden. Among the other identified barriers are: economic assessment of universal RV vaccination, cost-effectiveness of RV vaccination, funding of RV vaccination, and safety issues. Decentralized systems are expected to see less access and implementation of RV vaccines. Negative public perceptions on the necessity of RV vaccines could be serious barriers to access and use of RV vaccines in the studied countries. The implementation of RV vaccines is still low. Barriers to implementation vary according to settings. Nevertheless, public health authorities should promote greater public engagement and education for health-care providers on vaccination benefits in order to implement RV vaccination.

Impact of the rotavirus vaccine in Valladolid, Spain: An interrupted time series analysis

Rotavirus vaccines (RV) have decreased the infant morbidity and mortality in countries that included RV in their national schedule. Rotavirus vaccination is recommended by the Spanish Society of Pediatrics; however, Spain, as most countries in Europe, has authorized commercialization but not included RV in its national vaccination program. We assessed the impact of RV on the rotavirus hospitalization rate through an interrupted time series analysis. There was a 46.8% (95% CI: 29.3–60.2) decrease on the rotavirus hospitalizations rate in the study region after RV commercialization in 2006. Currently there is limited evidence about the impact of RV in Europe, especially among countries not offering systematic vaccination in their national schedule. Documentation of RV coverage, effectiveness and impact is urgently needed in these countries.

Effectiveness and impact of rotavirus vaccines in Europe, 2006–2014

Effectiveness and impact of rotavirus vaccines in Europe, 2006–2014

European Society for Paediatric Infectious Diseases consensus recommendations for rotavirus vaccination in Europe: update 2014.

The first evidence-based recommendations for rotavirus (RV) vaccination in Europe were prepared at the time of licensure of 2 live oral RV vaccines (Rotarix, GlaxoSmithKline Biologicals, and RotaTeq, Sanofi Pasteur MSD) in 2006 and published in 2008. Since then several countries in Europe and more globally have adopted universal RV vaccination of all healthy infants as part of their national immunization programs (NIPs). The experience from these NIPs has produced a wealth of post-introduction effectiveness data that, together with the evidence from prelicensure efficacy trials presented in the 2008 Recommendations, support the case of RV vaccination in Europe. The prelicensure safety trials of Rotarix and RotaTeq, each in populations of more than 60,000 infants, did not reveal risk of intussusception (IS), but postvaccination surveillance in several countries, particularly Australia and Mexico, has established that the risk of IS for both vaccines after the first dose might be between 1:50,000 and 1:80,000. Although it may be argued that the risk is acceptable vis-à-vis the great benefits of RV vaccination, this argument alone may not suffice, and every effort should be made to reduce the risk of IS. Considerable evidence, including postvaccination surveillance data from Germany, suggests that the risk of IS can be reduced by early administration of the first dose of oral RV vaccine. The previous European Society for Paediatric Infectious Diseases/European Society for Paediatric Gastroenterology, Hepatology and Nutrition recommendations held that the first dose of oral RV vaccine should be given between 6 and 12 weeks of age; this recommendation is sustained but with an emphasis toward the lower range of the recommended age, that is, preferably between 6 and 8 weeks of age. At the time of the earlier recommendations, experience of RV vaccination in premature infants and other special target groups was limited. It is now recommended with greater confidence than before that prematurely born infants should be vaccinated according to their calendar age as recommended for full-term infants. It is now strongly recommended that all HIV-infected or HIV-exposed infants should be vaccinated with oral RV vaccine. Although specific information on many immunodeficiencies is lacking, infants with known severe combined immunodeficiency should not receive live RV vaccine.

First Detection of P[6],G9 Rotaviruses in Hungary—An Imported Strain From India?

EuroRotaNet was launched to monitor rotavirus strain prevalence during and after introduction of rotavirus vaccines in Europe. In early 2007, we detected P[6],G9 rotaviruses to appear in Hungary, representing the first documented occurrence of this strain in our surveillance area. Epidemiologic data suggested that this strain was introduced from India.

Survey of rotavirus surveillance, laboratory capacity and disease burden in the eastern part of the WHO European Region

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.

European Society for Paediatric Infectious Diseases/European Society for Paediatric Gastroenterology, Hepatology, and Nutrition Evidence‐Based Recommendations for Rotavirus Vaccination in Europe: Executive Summary

European Society for Paediatric Infectious Diseases/European Society for Paediatric Gastroenterology, Hepatology, and Nutrition Evidence‐Based Recommendations for Rotavirus Vaccination in Europe: Executive Summary

Rotavirus Vaccination in Europe: The Time Has Finally Arrived

Rotavirus Vaccination in Europe: The Time Has Finally Arrived

Gastroenteritis by rotavirus in Spanish children. Analysis of the disease burden

Rotavirus is one of the most common causes of gastroenteritis worldwide. With the commercialisation of effective rotavirus vaccines in Europe in sight, it is necessary to provide studies which evaluate the disease burden. The aim of this study is two-fold, on one hand, to determine the burden of the rotavirus disease in Spanish children under the age of five, and on the other, to estimate the economic cost of these hospitalizations. The study was undertaken during a 5 year period (2000-2004). The rotavirus hospitalization rate was determined using the Minimum Basic Data Set of the national hospital discharge register. The observed data were compared with those expected by applying a model developed by the Centers for Disease Control and Prevention (CDC) adapted for European Countries. The financial expense of these hospitalizations was estimated. Of all admissions coded as gastroenteritis, 31.6% were due to rotavirus. The hospitalization rate by rotavirus was 480 cases per 100,000 children under five. These data are within the confidence range proposed by the adapted CDC model. The financial expense due to hospitalizations reaches 123,262 euros yearly in a Spanish University Hospital. In conclusion, rotavirus contributes significantly to the hospitalization of acute gastroenteritis. The rate of hospitalization by rotavirus is higher compared to other studies carried out in Spain. In view of future commercialisation of rotavirus vaccines, more in-depth analysis considering direct and indirect costs are necessary.

Rotavirus vaccines: considerations for successful implementation in Europe

A group of European experts in infectious diseases and vaccinology has met on several occasions to assess the rationale for universal vaccination against rotavirus infection of infants in Europe. On the basis of the available data, we concluded that vaccination was the best approach to prevent severe rotavirus gastroenteritis, and that European countries should consider implementing rotavirus vaccination in their routine immunisation programmes. The main barrier to the implementation of rotavirus vaccination in Europe is a general lack of awareness of stakeholders, policymakers, health-care professionals, and parents about rotavirus disease and the advantages of vaccination. Further studies on the cost of the disease and the benefit of vaccination, together with raising awareness are necessary steps to ensure successful implementation of rotavirus vaccination in Europe.

Economics of Rotavirus Gastroenteritis and Vaccination in Europe

Rotavirus is a major cause of gastroenteritis in children throughout Europe and the world. In addition to causing morbidity and mortality in children, rotavirus gastroenteritis (RVGE) creates a major economic burden on health care systems and families in Europe. The costs of hospital admissions for RVGE and nosocomial infections generate significant medical treatment costs throughout the region. Less information is available on the costs associated with less severe episodes and the costs borne by families, including lost time from work. The availability of rotavirus vaccines presents an effective opportunity to prevent RVGE and these associated economic costs, as well as providing protection to each child and hence benefiting the child's family. The adoption of rotavirus vaccine by health authorities in Europe will require a comparison of the costs and benefits. Economic evaluations that compare the costs of vaccination to the economic benefits of rotavirus vaccination will provide an estimate of its financial impact on health care systems and society. However, to provide a complete picture, economic evaluations of rotavirus vaccines will need to account for both the reduced costs and the reduced morbidity from prevented RVGE. Cost-effectiveness analyses based on quality-adjusted life years (QALYs) provide a systematic approach for assessing vaccination as a health investment, comparing the incremental costs associated with rotavirus vaccination and the reduced morbidity and mortality. QALYs provide a standardized approach for quantifying and comparing reductions in health-related quality of life and premature mortality. Although methodologic limitations exist in applying the QALY approach to childhood vaccines, their use in cost effectiveness analyses allows decision makers to consider the full health benefits of rotavirus and other vaccines.

Clinical Trials of Rotavirus Vaccines in Europe

Clinical trials of a live oral candidate rotavirus vaccine were started in 1982 and soon demonstrated that severe rotavirus disease can be prevented by vaccination. The first bovine candidate vaccine was withdrawn because of inconsistent efficacy, and studies of a rhesus rotavirus vaccine were initiated. A field trial of rhesus-human reassortant tetravalent rotavirus vaccine in Finland was pivotal for the licensure of this vaccine (RotaShield) in the United States in 1998. However, this vaccine was withdrawn in 1999 because of association with intussusception. Safety therefore became a major issue in the development of new candidate rotavirus vaccines. A pentavalent bovine-human reassortant rotavirus vaccine (RotaTeq) showed about 70% efficacy against any rotavirus disease and 100% efficacy against severe disease in Finland, according to the Clark scale. A large, multinational safety trial indicated no association of this vaccine with intussusception, and its licensure is under review in the EU. An attenuated human rotavirus vaccine (RIX4414; Rotarix) was developed from G1 rotavirus strain 89-12. A trial in Finland showed efficacy comparable with that of RotaShield, and a larger trial is under way in several European countries. In the first epidemic season, vaccine efficacy was 73% against any and 90% against severe rotavirus (mostly G1) gastroenteritis, according to the Vesikari scale. A large scale safety trial, conducted in Latin America plus Finland, indicated no increased risk of intussusception among recipients of Rotarix compared with placebo. The licensure of Rotarix is in process in the European Union.

Rotavirus vaccine studies in Europe.

Following the discovery and recognition of rotavirus as an important human enteropathogen, work towards the development of rotavirus vaccines was begun in the USA and Europe. The first candidate rotavirus vaccine was launched by SmithKline-RIT, Belgium, and studied in clinical trials in Finland, Yugoslavia, Italy, Switzerland, Austria and the UK. Efficacy trials in Finland of RIT 4237 strain live oral bovine rotavirus vaccine resulted in some fundamental findings about rotavirus immunity in humans: protection against disease rather than infection; better protection against severe than mild disease and heterotypic rather than homotypic protection. Another bovine rotavirus vaccine, strain WC-3, was studied briefly in France. Also studies of rhesus rotavirus vaccine were started early in Europe, and efficacy studies were carried out in Finland and Sweden. Recently, rhesus-human re-assortant tetravalent (RRV-TV) rotavirus vaccine was tested in a field trial in Finland this study was pivotal for the registration of the vaccine in the USA and European Union countries. Despite extensive experience with rotavirus vaccines in Europe, the need for such vaccines in many European countries still requires further assessment.