Prevention Of Rotavirus Gastroenteritis Research Articles

Effectiveness and impact of monovalent rotavirus vaccination in Afghanistan: a test-negative case–control analysis

Afghanistan introduced monovalent rotavirus vaccine (Rotarix) into its national immunisation schedule in January, 2018. While post-licensure studies have shown substantial declines in rotavirus gastroenteritis cases and deaths globally, there is little evidence of rotavirus vaccine effectiveness and impact from low-income countries in Asia. We aimed to evaluate the effectiveness of the Rotarix vaccine and the impact of Rotarix vaccine on rotavirus gastroenteritis hospitalisations (ie, hospital admissions) among children younger than 5 years in Afghanistan. We used a test-negative case-control design embedded in an active sentinel surveillance platform to evaluate vaccine effectiveness. Children born on or after Jan 1, 2018, who had documentation of their rotavirus vaccination status and who were admitted for acute gastroenteritis at one of four sentinel hospitals from May, 2018 to December, 2021 were eligible to be included. We used an unconditional logistic regression model to estimate vaccine effectiveness and 95% CIs for a complete series of doses compared with no rotavirus vaccine doses among patients admitted with acute gastroenteritis. Vaccine effectiveness against hospitalisation was calculated as (1 - [odds of being vaccinated in cases] / [odds of being vaccinated in controls]) × 100%. We compared pre-vaccine (2013-15) and post-vaccine (2019-21) surveillance data from two sites to calculate vaccine impact. The vaccine effectiveness analysis included 1172 cases and 2173 controls. Approximately 2108 (63·0%) of 3345 cases and controls were male, 1237 (37·0%) were female, and 2171 (65·0%) were aged 6-11 months. Two doses of Rotarix were 45% (95% CI 22-62) effective against rotavirus hospitalisation in children aged 6-59 months, adjusting for age, severity, admission year, and rotavirus season. Rotavirus positivity decreased from 51% pre-vaccine to 39% post-vaccine, resulting in a 39% adjusted reduction in rotavirus positivity among children younger than 5 years admitted with acute gastroenteritis. Rotarix showed moderate effectiveness in preventing rotavirus gastroenteritis hospitalisations, consistent with findings in other low-income countries. These findings support the continued administration of the rotavirus vaccine in Afghanistan. Gavi, the Vaccine Alliance. For the Dari translation of the abstract see Supplementary Materials section.

Parental preferences for rotavirus vaccination for their children under 5 years old in China: A discrete choice experiment

ABSTRACT Rotavirus vaccination is the most effective means to prevent rotavirus gastroenteritis, but its coverage in China is not ideal. We aimed to explore parental preferences for rotavirus vaccination for their children under 5years old to improve vaccination coverage. A Discrete Choice Experiment was conducted online on 415 parents with at least one child under 5years old in 3 cities. Five attributes including vaccine effectiveness, protection duration, risk of mild side-effects, out-of-pocket costs, and time required for vaccination were identified. Each attribute was set at three levels. Mixed-logit models were used to measure parental preferences and the relative importance of vaccine attributes. The optimal vaccination strategy was also explored. 359 samples were included in the analysis. The impacts of the vaccine attribute levels on vaccine choice were all statistically significant (p < .01), except for 1-hour vaccination time. The risk of mild side-effects was the most important factor influencing vaccination. The time required for vaccination was the least important attribute. The largest increase in vaccination uptake (74.45%) occurred with decreased the vaccine risk of mild side-effects from 1/10 to 1/50. The predicted vaccination uptake of the optimal vaccination scenario was 91.79%. When deciding about vaccination, parents preferred the rotavirus vaccination with lower risk of mild side-effects, higher effectiveness, longer protection duration, 2-hour vaccination time and lower cost. The authorities should support enterprises to develop vaccines with lower side-effects, higher effectiveness and longer protection duration in the future. We call for appropriate government subsidies for the rotavirus vaccine.

Evaluation of some biochemical parameters of pediatric patients hospitalized for rotavirus in Şirnak Province: A retrospective review

Rotavirus gastroenteritis is an important cause of worldwide morbidity and mortality in infants and children. The main cause of mortality is dehydration due to fluid loss and malnutrition. This study aims to examine the guiding parameters of uric acid and creatinine levels in the detection of dehydration and fluid deficit and inpatient management in cases of rotavirus gastroenteritis. Children who applied to Şirnak State Hospital, Pediatrics Polyclinics, children (6 months-18 years old) whose faecal samples were sent to the laboratory by the research pediatrician considering the diagnosis of rotavirus and whose microbiological examinations were confirmed by immunochromatographic methods (6 months-18 years old), were included in the study by scanning the system. When positive patients were evaluated, the mean age for serum uric acid was 1.06±1.53 and the mean age for serum creatinine was 1.10±1.37. The median value was 3.75 mg/dL in negative patients with serum uric acid levels, and 5.25 mg/dL in positive patients, which was statistically significant (p&lt;0.01). The median value of serum creatinine level was 0.41 mg/dL in negative patients and 0.43 mg/dL in positive patients, which was statistically significant (p&lt;0.05). With this study carried out in Şirnak province, we think that children in the region are severely affected by the rotavirus and face severe dehydration. Therefore, we think that all parameters affected by rotavirus should be evaluated according to regions and parents should be educated about the importance of rotavirus vaccine in the prevention of rotavirus gastroenteritis.

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.

Cost-effectiveness of rotavirus vaccination in Mozambique

IntroductionRotavirus is one of the most common cause of severe gastroenteritis in children, with the largest mortality burden in low- and middle-income countries. To prevent rotavirus gastroenteritis, Mozambique introduced ROTARIX® vaccine in 2015, however, its cost-effectiveness has never been established in the country. In 2018, additional vaccines became available globally. This study estimates the cost-effectiveness of the recently introduced ROTARIX in Mozambique and compares the cost-effectiveness of ROTARIX®, ROTAVAC®, and ROTASIIL® to inform future use. MethodsWe used a decision-support model to calculate the potential cost-effectiveness of vaccination with ROTARIX compared to no vaccination over a five-year period (2016–2020) and to compare the cost-effectiveness of ROTARIX, ROTAVAC, and ROTASIIL to no vaccination and to each other over a ten-year period (2021–2030). The primary outcome was the incremental cost per disability-adjusted life-year (DALY) averted from a government perspective. We assessed uncertainty through sensitivity analyses. ResultsFrom 2016 to 2020, we estimate the vaccine program with ROTARIX cost US$12.3 million, prevented 4,628 deaths, and averted US$3.1 million in healthcare costs. The cost per DALY averted was US$70. From 2021 to 2030, we estimate all three vaccines could prevent 9,000 deaths and avert US$7.8 million in healthcare costs. With Global Alliance for Vaccines and Immunization (Gavi) support, ROTARIX would have the lowest vaccine program cost (US$31 million) and 98 % probability of being cost-effective at a willingness-to-pay threshold of 0.5x GDP per capita. Without Gavi support, ROTASIIL would have the lowest vaccine program cost (US$75.8 million) and 30 % probability of being cost-effective at the same threshold. ConclusionROTARIX vaccination had a substantial public health impact in Mozambique between 2016 and 2020. ROTARIX is currently estimated to be the most cost-effective product, but the choice of vaccine should be re-evaluated as more evidence emerges on the price, incremental delivery cost, wastage, and impact associated with each of the different rotavirus vaccines.

The economic burden of rotavirus hospitalization among children < 5 years of age in selected hospitals in Bangladesh

BackgroundRotavirus is a common cause of severe acute gastroenteritis among young children. Estimation of the economic burden would provide informed decision about investment on prevention strategies (e.g., vaccine and/or behavior change), which has been a potential policy discussion in Bangladesh for several years. MethodsWe estimated the societal costs of children <5 years for hospitalization from rotavirus gastroenteritis (RVGE) and incidences of catastrophic health expenditure. A total of 360 children with stool specimens positive for rotavirus were included in this study from 6 tertiary hospitals (3 public and 3 private). We interviewed the caregiver of the patient and hospital staff to collect cost from patient and health facility perspectives. We estimated the economic cost considering 2015 as the reference year. ResultsThe total societal per-patient costs to treat RVGE in the public hospital were 126 USD (95% CI: 116–136) and total household costs were 161 USD (95% CI: 145–177) in private facilities. Direct costs constituted 38.1% of total household costs. The out-of-pocket payments for RVGE hospitalization was 23% of monthly income and 76% of households faced catastrophic healthcare expenditures due to this expense. The estimated total annual household treatment cost for the country was 10 million USD. ConclusionsA substantial economic burden of RVGE in Bangladesh was observed in this study. Any prevention of RVGE through cost-effective vaccination or/and behavioural change would contribute to substantial economic benefits to Bangladesh.

Paediatrics: how to manage viral gastroenteritis.

BackgroundViral gastroenteritis is the most common diarrhoeal disorder seen in general practice and emergency departments. This article aims to provide a narrative updated review on the evaluation and management of viral gastroenteritis in children.MethodsA PubMed search was performed with Clinical Queries using the key term ‘viral gastroenteritis’. The search strategy included clinical trials, meta-analyses, randomized controlled trials, observational studies and reviews. The search was restricted to the English literature and the paediatric population.ResultsAcute viral gastroenteritis is usually self-limiting. However, it can lead to dehydration and electrolyte imbalance if not properly treated. Adequate fluids containing physiological concentrations of glucose and electrolytes should be provided to compensate for gastrointestinal losses and cover maintenance needs. Oral rehydration therapy is as effective as intravenous (IV) fluid therapy for rehydration for children with mild-to-moderate dehydration. Measurements of serum electrolytes, creatinine and glucose are usually not necessary and should only be considered in a subset of children with severe dehydration who require hospitalization and IV therapy. Judicious use of ondansetron can increase the success rate of oral rehydration therapy and minimize the need for IV therapy and hospitalization.ConclusionAcute viral gastroenteritis is associated with substantial morbidity in developed countries and significant mortality in developing countries. Physicians should educate caregivers on proper personal hygiene and handwashing to prevent faecal to oral transmission of the pathogen as well as the importance of rotavirus vaccine in the prevention of rotavirus gastroenteritis. Several norovirus vaccines are currently undergoing clinical trials with promising results. It is hoped that development of an effective norovirus vaccine will further reduce the incidence of viral gastroenteritis.

Correction to: Pentavalent rotavirus vaccine (RotaTeq®) in the prevention of rotavirus gastroenteritis: a profile of its use in the EU

“Monovalent or combination infant vaccines containing one or more of the following: diphtheria-tetanus-acellular pertussis vaccine, Haemophilus influenzae type b vaccine, inactivated poliovirus vaccine or oral poliovirus vaccine, pneumococcal conjugate vaccine and group C meningococcal conjugate vaccine”

Pentavalent rotavirus vaccine (RotaTeq®) in the prevention of rotavirus gastroenteritis: a profile of its use in the EU

RotaTeq® is a three-dose, pentavalent, human-bovine reassortment vaccine, indicated for the prevention of rotavirus gastroenteritis (RVGE) in infants aged 6–32 weeks in the EU. The vaccine solution is given orally and can be administered with a number of common childhood vaccines. In the pivotal REST study, RotaTeq® showed high protective efficacy with respect to reductions in the RVGE incidence and associated hospitalizations or emergency department visits. The effectiveness and impact of the vaccine against RVGE-related healthcare use were demonstrated in several real-world studies. RotaTeq® was generally well tolerated, with no or minimal risk of intussusception.

Human Neonatal Rotavirus Vaccine (RV3-BB) to Target Rotavirus from Birth

BackgroundA strategy of administering a neonatal rotavirus vaccine at birth to target early prevention of rotavirus gastroenteritis may address some of the barriers to global implementation of a rotavirus vaccine.MethodsWe conducted a randomized, double-blind, placebo-controlled trial in Indonesia to evaluate the efficacy of an oral human neonatal rotavirus vaccine (RV3-BB) in preventing rotavirus gastroenteritis. Healthy newborns received three doses of RV3-BB, administered according to a neonatal schedule (0 to 5 days, 8 weeks, and 14 weeks of age) or an infant schedule (8 weeks, 14 weeks, and 18 weeks of age), or placebo. The primary analysis was conducted in the per-protocol population, which included only participants who received all four doses of vaccine or placebo within the visit windows, with secondary analyses performed in the intention-to-treat population, which included all participants who underwent randomization.ResultsAmong the 1513 participants in the per-protocol population, severe rotavirus gastroenteritis occurred up to the age of 18 months in 5.6% of the participants in the placebo group (28 of 504 babies), in 1.4% in the neonatal-schedule vaccine group (7 of 498), and in 2.7% in the infant-schedule vaccine group (14 of 511). This resulted in a vaccine efficacy of 75% (95% confidence interval [CI], 44 to 91) in the neonatal-schedule group (P<0.001), 51% (95% CI, 7 to 76) in the infant-schedule group (P=0.03), and 63% (95% CI, 34 to 80) in the neonatal-schedule and infant-schedule groups combined (combined vaccine group) (P<0.001). Similar results were observed in the intention-to-treat analysis (1649 participants); the vaccine efficacy was 68% (95% CI, 35 to 86) in the neonatal-schedule group (P=0.001), 52% (95% CI, 11 to 76) in the infant-schedule group (P=0.02), and 60% (95% CI, 31 to 76) in the combined vaccine group (P<0.001). Vaccine response, as evidenced by serum immune response or shedding of RV3-BB in the stool, occurred in 78 of 83 participants (94%) in the neonatal-schedule group and in 83 of 84 participants (99%) in the infant-schedule group. The incidence of adverse events was similar across the groups. No episodes of intussusception occurred within the 21-day risk period after administration of any dose of vaccine or placebo, and one episode of intussusception occurred 114 days after the third dose of vaccine in the infant-schedule group.ConclusionsRV3-BB was efficacious in preventing severe rotavirus gastroenteritis when administered according to a neonatal or an infant schedule in Indonesia. (Funded by the Bill and Melinda Gates Foundation and others; Australian New Zealand Clinical Trials Registry number, ACTRN12612001282875.)

Effectiveness of rotavirus pentavalent vaccine under a universal immunization programme in Israel, 2011–2015: a case–control study

ObjectivesThe use of rotavirus pentavalent vaccine (RotaTeq®) as a sole vaccine within rotavirus universal immunization programmes remains limited. We examined the effectiveness of RotaTeq in preventing rotavirus gastroenteritis (RVGE) hospitalization in Israel, after the introduction of universal immunization against the disease. MethodsA test-negative case–control study included age-eligible children for universal RotaTeq immunization (aged 2–59 months, born in 2011–2015). Cases (n = 98) were patients who tested positive for rotavirus by immunochromatography; those who tested negative (n = 628) comprised the control group. Information on rotavirus immunization history was obtained through linkage with a national immunization registry. Vaccination status was compared between cases and controls, adjusted odds ratios (aORs) were obtained from logistic regression models, and vaccine effectiveness calculated as (1 − aOR)*100. ResultsImmunization with RotaTeq was less frequent in RVGE cases (73.5%) than in controls (90.1%), p < 0.001; this association persisted after controlling for potential confounders. Effectiveness of the complete vaccine series was estimated at 77% (95% confidence interval (CI): 49–90) in children aged 6–59 months, and 86% (95% CI: 65–94) in children aged 6–23 months; whereas for the incomplete series, the respective estimates were 72% (95% CI: 28–89) and 75% (95% CI: 30–91). Vaccine effectiveness was estimated at 79% (95% CI: 45–92) against G1P[8]-associated RVGE hospitalizations and 69% (95% CI: 11–89) against other genotype-RVGE hospitalizations. ConclusionsHigh effectiveness of RotaTeq as the sole rotavirus vaccine in a universal immunization programme was demonstrated in a high-income country. Although partial vaccination conferred protection, completing the vaccine series is warranted to maximize the benefit.

Long-term Consistency in Rotavirus Vaccine Protection: RV5 and RV1 Vaccine Effectiveness in US Children, 2012-2013.

Using a multicenter, active surveillance network from 2 rotavirus seasons (2012 and 2013), we assessed the vaccine effectiveness of RV5 (RotaTeq) and RV1 (Rotarix) rotavirus vaccines in preventing rotavirus gastroenteritis hospitalizations and emergency department (ED) visits for numerous demographic and secular strata. We enrolled children hospitalized or visiting the ED with acute gastroenteritis (AGE) for the 2012 and 2013 seasons at 7 medical institutions. Stool specimens were tested for rotavirus by enzyme immunoassay and genotyped, and rotavirus vaccination histories were compared for rotavirus-positive cases and rotavirus-negative AGE controls. We calculated the vaccine effectiveness (VE) for preventing rotavirus associated hospitalizations and ED visits for each vaccine, stratified by vaccine dose, season, clinical setting, age, predominant genotype, and ethnicity. RV5-specific VE analyses included 2961 subjects, 402 rotavirus cases (14%) and 2559 rotavirus-negative AGE controls. RV1-specific VE analyses included 904 subjects, 100 rotavirus cases (11%), and 804 rotavirus-negative AGE controls. Over the 2 rotavirus seasons, the VE for a complete 3-dose vaccination with RV5 was 80% (confidence interval [CI], 74%-84%), and VE for a complete 2-dose vaccination with RV1 was 80% (CI, 68%-88%).Statistically significant VE was observed for each year of life for which sufficient data allowed analysis (7 years for RV5 and 3 years for RV1). Both vaccines provided statistically significant genotype-specific protection against predominant circulating rotavirus strains. In this large, geographically and demographically diverse sample of US children, we observed that RV5 and RV1 rotavirus vaccines each provided a lasting and broadly heterologous protection against rotavirus gastroenteritis.

Post-marketing monitoring of intussusception after rotavirus vaccination in Japan.

Purpose Rotarix TM was launched in November 2011 in Japan to prevent rotavirus gastroenteritis. Some studies suggest that Rotarix TM may have a temporal association with a risk of intussusception (IS). We assessed a possible association between IS and Rotarix TM vaccination in Japan.MethodsAll IS cases spontaneously reported post‐vaccination (Brighton collaboration levels 1, 2, and 3) were extracted from the GlaxoSmithKline spontaneous report database on the 11th of January 2013. Expected numbers of IS cases were estimated using the number of vaccine doses distributed and the Japanese incidence rate of IS stratified by month of age. The observed versus expected analysis considered the IS cases for each risk period (7 and 30 days post‐vaccination) and for each vaccine dose (two doses).ResultsBefore January 2013, approximately 601 000 Rotarix TM doses were distributed in Japan. For a risk period of 7 days post‐dose 1 and post‐dose 2, 10 and five IS cases were observed, whereas 3.4 and 7.6 were expected, providing an observed‐to‐expected ratio of 2.96 (95% confidence interval [CI]: 1.42; 5.45) and 0.66 (95% CI: 0.21; 1.53), respectively. For a risk period of 30 days post‐dose 1 and post‐dose 2, 14 and eight cases were observed, whereas 14.5 and 32.7 were expected, providing an observed‐to‐expected ratio of 0.97 (95% CI: 0.53; 1.62) and 0.24 (95% CI: 0.11; 0.48), respectively.ConclusionA statistically significant excess of IS cases was observed within 7 days post‐dose 1, but not post‐dose 2. These results are consistent with previous observations in large post‐marketing safety studies in other world regions. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

Pentavalent Rotavirus Vaccine in Infants With Surgical Gastrointestinal Disease

Pentavalent rotavirus vaccine (RV5) has been shown to be well-tolerated and efficacious in preventing rotavirus gastroenteritis in healthy infants. Safety and immunogenicity of RV5 in infants with surgical gastrointestinal disease have not been studied. The aim of the present study was to evaluate the safety and immunogenicity of RV5 in infants with a history of congenital or acquired intestinal disease requiring resection compared with healthy infants. Infants with intestinal resection were matched by gestational age and chronological age to healthy infants (controls). Dose 1 of RV5 was given at 10 to 12 weeks of chronological age. Doses 2 and 3 were given at intervals of 4 to 10 weeks, with all 3 doses given by 32 weeks. All infants were monitored for adverse events (AEs) by telephone calls, clinic visits, and parental written reports during the first 42 days after each dose and monthly thereafter by telephone for 12 months. Serum anti-rotavirus immunoglobulin A (IgA) titers were measured prevaccination and 2 weeks after dose 3. A total of 5 infants with surgical gastrointestinal disease and 3 control subjects were enrolled. All participants (100%) mounted a 3-fold increase in serum anti-rotavirus IgA geometric mean titer postvaccination. RV5 administration to surgical infants was well tolerated with a majority of AEs being attributed to the underlying medical condition. Postvaccination serum anti-rotavirus IgA levels indicate that RV5 is immunogenic in infants with a history of bowel resection, despite varying lengths of residual bowel. RV5 was well tolerated with few vaccine-related AEs.

Direct, Indirect, Total, and Overall Effectiveness of the Rotavirus Vaccines for the Prevention of Gastroenteritis Hospitalizations in Privately Insured US Children, 2007-2010

We demonstrate how direct, indirect, total, and overall effectiveness estimates and absolute benefits of rotavirus vaccines vary through the years following vaccine introduction. Privately insured US children in a large claims database were followed from age 8 months until they 1) experienced a hospitalization for rotavirus or acute gastroenteritis; 2) lost continuous health plan enrollment; 3) turned 20 months of age; or 4) reached the end of the study period. Vaccine effectiveness estimates in preventing rotavirus and acute gastroenteritis hospitalizations were estimated using Cox proportional hazards regression, stratified by calendar year and adjusted for birth month. Incidence rate differences were estimated to determine the absolute number of gastroenteritis hospitalizations prevented in the cohort. Among 905,718 children, 51%, 66%, 80%, and 86% received 1 or more doses of rotavirus vaccine in each year from 2007 to 2010. The direct vaccine effectiveness of 1 or more doses of rotavirus vaccine in preventing rotavirus gastroenteritis hospitalizations ranged from 87% to 92% each year. Accounting for indirect protection increased estimates of vaccine effectiveness by an additional 3%-8% among those vaccinated. Failing to account for population-level vaccine benefits in 2010, when circulation of rotavirus was low, could underestimate the sustained impact of the vaccine program.

Intussusception incidence among infants in the UK and Republic of Ireland: A pre-rotavirus vaccine prospective surveillance study

IntroductionIntussusception, an abdominal emergency in young children, has been linked to a previous vaccine used to prevent rotavirus gastroenteritis. Although this vaccine was withdrawn, recent studies have suggested a potential, very small increased risk of intussusception following the administration of newly developed rotavirus vaccines. We aimed to determine the baseline incidence of intussusception among infants in the UK and Republic of Ireland – prior to the imminent introduction of the rotavirus vaccine into the UK schedule this year. MethodsProspective, active surveillance via the established British Paediatric Surveillance Unit (BPSU) was carried out from March 2008 to March 2009. Clinicians across 101 National Health Service (and equivalent) hospitals, including 27 paediatric surgical centres, reported cases admitted for intussusception in the UK and Republic of Ireland. The standard Brighton Collaboration case definition was used with only definite cases included for incidence estimation. ResultsThe study response rate was 94.5% (379 questionnaires received out of 401 case notifications). A total of 250 definite cases of intussusception were identified. The annual incidence among infants in the UK and Republic of Ireland was 24.8 (95% CI: 21.7–28.2) and 24.2 (95% CI: 15.0–37.0) per 100,000 live births. In the UK, the highest incidence occurred in Northern Ireland (40.6, 95% CI: 21.0–70.8), followed by Scotland (28.7, 95% CI: 17.5–44.3), England (24.2, 95% CI: 20.9–27.9), then Wales (16.9, 95% CI: 6.8–34.8). In England, regional incidence was highest in London and lowest in the West Midlands. By age, the highest incidence (50.3/100,000 live births, 95% CI: 33.4–72.7) occurred in the fifth month of life (for England). A seasonal trend in the presentation of intussusception was observed with the incidence significantly (p=0.001) increased during winter and spring. ConclusionThe baseline rates obtained in this study will inform rotavirus vaccine-safety policy by enabling comparison with post-introduction incidence.

Rotavirus vaccine RIX4414 (Rotarix®): a guide to its use in preventing rotavirus gastroenteritis in the EU

The human monovalent rotavirus vaccine RIX4414 (Rotarix®) is indicated for the prevention of rotavirus gastroenteritis (RVGE) in infants aged 6 to 24 weeks in the EU. It offers broad sustained protective efficacy against RVGE including severe cases, and reduces the incidence of associated hospitalizations. It does not interfere with the immunogenicity of other paediatric vaccinations, and is considered safe.

Effectiveness of an Incomplete RotaTeq (RV5) Vaccination Regimen in Preventing Rotavirus Gastroenteritis in the United States

Effectiveness of the pentavalent rotavirus vaccine (RV5) after administration of the complete (3 dose) regimen has been demonstrated in a real-world setting. This study assessed the effectiveness of RV5 following partial completion of the 3-dose regimen. Using a large national health insurance claims database, 2 cohorts of infants (those who received RV5 and a concurrent group who received diphtheria-tetanus-acellular pertussis, but not RV5) were followed through the 2007 and 2008 rotavirus seasons (January 1 to May 31) to identify cases of rotavirus gastroenteritis and all-cause gastroenteritis resulting in medical care encounters. Vaccine effectiveness following the first and the second RV5 doses was estimated by quantifying reductions in hospitalizations, emergency department (ED) and physician office visits. A first RV5 dose was received by 42,306 infants whereas 28,417 infants in the concurrent comparison group received a first diphtheria-tetanus-acellular pertussis dose; 43,704 infants received a second RV5 dose, and 31,810 infants received a second diphtheria-tetanus-acellular pertussis dose. One dose of RV5 was associated with 88% effectiveness against rotavirus gastroenteritis hospitalizations and ED visits and 44% effectiveness against all-cause gastroenteritis hospitalizations and ED visits. A 2-dose regimen of RV5 was associated with 94% effectiveness against rotavirus gastroenteritis hospitalizations and ED visits and 40% effectiveness against all-cause gastroenteritis hospitalizations and ED visits. The RV5 vaccine exhibits effectiveness against rotavirus gastroenteritis even before completing the full 3-dose regimen. These results are of particular relevance when considering the benefits of a partially completed rotavirus vaccine series.

Pharmacoeconomic Spotlight on Rotavirus Vaccine RIX4414 (Rotarix™) in the Prevention of Rotavirus Gastroenteritis in Developing Countries†

This article provides an overview of the clinical profile of rotavirus vaccine RIX4414 (Rotarix™) in the prevention of rotavirus gastroenteritis (RVGE) in developing countries, followed by a review of pharmacoeconomic analyses with the vaccine in low- and middle-income countries. RVGE is associated with significant morbidity and mortality among children <5 years of age in developing countries. The protective efficacy of a two-dose oral series of rotavirus vaccine RIX4414 has been demonstrated in several well designed clinical trials conducted in developing countries, and the 'real-world' effectiveness of the vaccine has also been shown in naturalistic and case-control trials after the introduction of universal vaccination programs with RIX4414 in Latin American countries. The WHO recommends universal rotavirus vaccination programs for all countries. Numerous modelled cost-effectiveness analyses have been conducted with rotavirus vaccine RIX4414 across a wide range of low- and middle-income countries. Although data sources and assumptions varied across studies, results of the analyses consistently showed that the introduction of the vaccine as part of a national vaccination program would be very cost effective compared with no rotavirus vaccination program, according to widely used cost-effectiveness thresholds for developing countries. Vaccine price was not known at the time the analyses were conducted and had to be estimated. In sensitivity analyses, rotavirus vaccine RIX4414 generally remained cost effective at the highest of a range of possible vaccine prices considered. Despite these favorable results, decisions regarding the implementation of universal vaccination programs with RIX4414 may also be contingent on budgetary and other factors, underscoring the importance of subsidized vaccination programs for poor countries through the GAVI Alliance (formerly the Global Alliance for Vaccines and Immunization).

Effectiveness of rotavirus vaccines in preventing cases and hospitalizations due to rotavirus gastroenteritis in Navarre, Spain

Two rotavirus vaccines have been available since 2006. This study evaluates the effectiveness of these vaccines using a test-negative case-control design in Navarre, Spain. We included children 3-59 months of age who sought medical care for gastroenteritis and for whom stool samples were taken between January 2008 and June 2011. About 9% had received the pentavalent vaccine (RotaTeq) and another 8% received the monovalent vaccine (Rotarix). Cases were the 756 children with confirmed rotavirus and controls were the 6036 children who tested negative for rotavirus. Thirty-five percent of cases and 9% of controls had required hospitalization (p<0.0001). The adjusted effectiveness of complete vaccination was 78% (95% CI: 68-85%) in preventing rotavirus gastroenteritis and 83% (95% CI: 65-93%) in preventing hospitalization for rotavirus gastroenteritis. No differences between the two vaccines were detected (p=0.4523). Both vaccines were highly effective in preventing cases and hospital admissions in children due to rotavirus gastroenteritis.