Rotavirus Hospitalizations Research Articles

National stakeholder preferences for next-generation rotavirus vaccines: Results from a six-country study

BackgroundCurrently available live, oral rotavirus vaccines (LORVs) have significantly reduced severe rotavirus hospitalizations and deaths worldwide. However, LORVs are not as effective in low- and middle-income countries (LMIC) where rotavirus disease burden is highest. Next-generation rotavirus vaccine (NGRV) candidates in development may have a greater public health impact where they are needed most. The feasibility and acceptability of possible new rotavirus vaccines were explored as part of a larger public health value proposition for injectable NGRVs in LMICs. ObjectiveTo assess national stakeholder preferences for currently available LORVs and hypothetical NGRVs and understand rationales and drivers for stated preferences. MethodsInterviews were conducted with 71 national stakeholders who influence vaccine policy and national programming. Stakeholders from Ghana, Kenya, Malawi, Peru, Senegal, and Sri Lanka were interviewed using a mixed-method guide. Vaccine preferences were elicited on seven vaccine comparisons involving LORVs and hypothetical NGRVs based on information presented comparing the vaccines’ attributes. Reasons for vaccine preference were elicited in open-ended questions, and the qualitative data were analyzed on key preference drivers. ResultsNearly half of the national stakeholders interviewed preferred a highly effective standalone, injectable NGRV over current LORVs. When presented as having similar efficacy to the LORV, however, very few stakeholders preferred the injectable NGRV, even at substantially lower cost. Similarly, a highly effective standalone injectable NGRV was generally not favored over an equally effective oral NGRV following a neonatal-infant schedule, despite higher cost of the neonatal option. An NGRV-DTP-containing combination vaccine was strongly preferred over all other options, whether delivered alone with efficacy similar to current LORVs or co-administered alongside an LORV (LORV + NGRV-DTP) to increase efficacy. ConclusionResults from these national stakeholder interviews provide valuable insights to inform ongoing and future NGRV research and development.

Rotavirus Vaccine Safety and Effectiveness in Infants With High-Risk Medical Conditions.

Rotavirus vaccination has 87% to 100% effectiveness against severe rotavirus acute gastroenteritis (AGE) in healthy infants in high-income countries. Little is known whether infants with medical risk conditions (MRCs) are equally protected and if the vaccine is equally well tolerated. We conducted a quasi-experimental prospective multicenter before-after cohort study to assess the vaccine effectiveness (VE) and safety profile of the human rotavirus vaccine (HRV) among MRC infants that required prolonged or frequent postnatal care. The Netherlands has no national rotavirus immunization program, but HRV was implemented in routine care for MRC infants in 13 Dutch hospitals. Participants in the before and after cohort, HRV unvaccinated and vaccinated, respectively, were followed for occurrence of (rotavirus) AGE. VE of at least 1 dose was estimated by using time-to-event analysis for severe rotavirus AGE. Vaccine-related serious adverse event (AEs) after HRV were retrieved systematically from medical charts. Solicited AEs after vaccinations were prospectively collected and compared between vaccination time points with or without HRV. In total, 1482 high-risk infants with MRC were enrolled, including 631 in the before and 851 in the after cohorts; 1302 infants were premature (88.3%), 447 were small for gestational age (30.2%), and 251 had at least 1 congenital disorder (17.0%). VE against severe rotavirus AGE was 30% (95% confidence interval [CI]: -36% to 65%). Overall, the observed number of rotavirus hospitalizations was low and not significantly different between the cohorts (2 and 2, respectively). The rate of vaccine-related serious AE was 0.24 per 100 vaccine doses. The adjusted risk ratio for any AE after HRV vaccination compared with other routine vaccinations was 1.09 (95% CI: 1.05 to 1.12) for concomitant administration and 0.91 (95% CI: 0.81 to 0.99) for single HRV administration. Gastrointestinal AEs were 10% more frequent after HRV. In contrast to previous findings among healthy term infants, in routine use, HRV offered limited protection to vulnerable medical risk infants. HRV is generally well tolerated in this group in single administration, but when coadministered with routine vaccines, it is associated with higher risk of (mostly gastrointestinal) AE. Our study highlights the importance of studying vaccine performance in subgroups of medically vulnerable infants.

Impact of rotavirus vaccination on rotavirus hospitalizations in Taiwanese children

In 2006, two rotavirus vaccines were licensed in Taiwan but were not added to the national immunization schedule. National Health Insurance data from 2003 through 2017 were used to compare rotavirus-associated pediatric hospitalizations before and after vaccine introduction. Rotavirus hospitalization rates among children < 5 years of age significantly declined by 24% (95% confidence interval [CI] 23 – 25%) in post-vaccine compared to pre-vaccine rotavirus seasons. Rotavirus hospitalization rates declined by 42% (95% CI 39 – 44%) among infants < 12 months of age, and by 38% (95% CI 36 – 40%) among children 12 – 23 months of age. These findings suggest that, despite not being included in the national immunization schedule, rotavirus vaccines had a measurable impact on reducing rotavirus hospitalization burden among Taiwanese children.

Impact of Monovalent Rotavirus Vaccine on Rotavirus Hospitalizations among Children Younger Than 5 Years of Age in the Ouest and Artibonite Departments, Haiti, 2013 to 2019.

Rotavirus is responsible for 26% of diarrheal deaths in Latin America and the Caribbean. Haiti introduced the monovalent rotavirus vaccine in April 2014. The objective of this analysis is to describe the impact of the rotavirus vaccine on hospitalizations among Haitian children younger than 5 years old during the first 5 years after introduction. This analysis includes all children with diarrhea who were enrolled as part of a sentinel surveillance system at two hospitals from May 2013 to April 2019. We compare the proportion of rotavirus-positive specimens in each post-vaccine introduction year to the pre-vaccine period. To account for the potential dilution of the proportion of rotavirus-positive specimens from a waning cholera outbreak, we also analyzed annual trends in the absolute number of positive stools, fit a two-component finite-mixture model to the negative specimens, and fit a negative binomial time series model to the pre-vaccine rotavirus-positive specimens to predict the number of rotavirus diarrhea hospital admissions in the absence of rotavirus vaccination. The overall percentage of rotavirus-positive specimens declined by 22% the first year after introduction, increased by 17% the second year, and declined by 33% to 50% the subsequent 3 years. All sensitivity analyses confirmed an overall decline. We observed a clear annual rotavirus seasonality before and after vaccine introduction, with the greatest activity in December through April, and a biennial pattern, with high sharp peaks and flatter longer periods of increased rotavirus activity in alternating years, consistent with suboptimal vaccination coverage. Overall, our study shows evidence that the introduction of the rotavirus vaccine reduced the burden of severe rotavirus diarrhea.

Counting the cost of rotavirus hospitalisation among young children in Bangladesh

Counting the cost of rotavirus hospitalisation among young children in Bangladesh

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.

Serological Humoral Immunity Following Natural Infection of Children with High Burden Gastrointestinal Viruses.

Acute gastroenteritis (AGE) is a major cause of morbidity and mortality worldwide, resulting in an estimated 440,571 deaths of children under age 5 annually. Rotavirus, norovirus, and sapovirus are leading causes of childhood AGE. A successful rotavirus vaccine has reduced rotavirus hospitalizations by more than 50%. Using rotavirus as a guide, elucidating the determinants, breath, and duration of serological antibody immunity to AGE viruses, as well as host genetic factors that define susceptibility is essential for informing development of future vaccines and improving current vaccine candidates. Here, we summarize the current knowledge of disease burden and serological antibody immunity following natural infection to inform further vaccine development for these three high-burden viruses.

Burden and Trends of Severe Rotavirus Infections and Allcause Acute Gastroenteritis Hospital Episodes in Children Under Five Years Old in Mainland Portugal

Introduction: Rotavirus infections are a leading cause of severe acute gastroenteritis in children under five years old. In December 2019, Portugal announced the inclusion of the rotavirus vaccine, already available for private purchase, in the National Immunization Program. We present the first nationwide analysis of the burden and trends of rotavirus and acute gastroenteritis hospital episodes in children under five years old in mainland Portugal (2014 - 2017).Material and Methods: We used the hospital morbidity database and the Death Certificate Information System to identify hospital episodes and deaths of rotavirus and acute gastroenteritis based on the codes of the International Classification of Diseases. We described the number and rates of hospital episodes disaggregated by age group, sex, geographical units, and the seasonality and trends over the study period.Results: On average, during the study period, there were 1985 annual hospital episodes among children under five years old. The annual rate was 48.0/10 000 children (95% CI 46.9 - 49.0). Rates were consistently higher in younger children, and 67.8% episodes occurred in children under 24 months. We found a seasonal pattern with a major peak in the early spring.Discussion: Our results were consistent with the current knowledge on rotavirus and acute gastroenteritis hospital episodes in Europe. Additional studies are needed to identify the risk factors and high-risk groups for hospital attendance.Conclusion: Rotavirus and acute gastroenteritis hospital episodes in children under five years old in mainland Portugal represent an important health and economic burden. In the future, monitoring this burden and these trends in relation with rotavirus vaccine coverage could be useful in order to assess the impact of the vaccination programme on the change in hospital episodes.

Rotavirus vaccines: progress and new developments

ABSTRACT Introduction Rotavirus is the primary cause of severe acute gastroenteritis among children under the age of five globally, leading to 128,500 to 215,000 vaccine-preventable deaths annually. There are six licensed oral, live-attenuated rotavirus vaccines: four vaccines pre-qualified for global use by WHO, and two country-specific vaccines. Expansion of rotavirus vaccines into national immunization programs worldwide has led to a 59% decrease in rotavirus hospitalizations and 36% decrease in diarrhea deaths due to rotavirus in vaccine-introducing countries. Areas covered This review describes the current rotavirus vaccines in use, global coverage, vaccine efficacy from clinical trials, and vaccine effectiveness and impact from post-licensure evaluations. Vaccine safety, particularly as it relates to the risk of intussusception, is also summarized. Additionally, an overview of candidate vaccines in the pipeline is provided. Expert opinion Considerable evidence over the past decade has demonstrated high effectiveness (80–90%) of rotavirus vaccines at preventing severe rotavirus disease in high-income countries, although the effectiveness has been lower (40–70%) in low-to-middle-income countries. Surveillance and research should continue to explore modifiable factors that influence vaccine effectiveness, strengthen data to better evaluate newer rotavirus vaccines, and aid in the development of future vaccines that can overcome the limitations of current vaccines.

Fourteen years’ clinical experience and the first million babies protected with human live-attenuated vaccine against rotavirus disease in Italy

ABSTRACT Rotavirus (RV) causes up to half of hospital and community acute gastroenteritis (AGE) cases in young children in Italy. Two RV vaccines, available since 2006, are human RV (HRV) and human bovine RV (HBRV). This report looks back at the implementation of RV vaccination with HRV in Italy, and at HRV current and future perspectives. Initial regional policies led to national implementation by 2018, after scientific societies’ disease awareness efforts. Following vaccination, RV hospitalizations declined significantly, and cost savings were observed. The two-dose HRV vaccine is easily administered during compulsory vaccine visits, helping increase coverage. Intussusception, a serious event in children <1 year, was reported in Italy with a rate of 33–40 per 100,000 infants. RV vaccination presents a low increased risk of intussusception after the first dose, estimated at 0.6 cases per 100,000 doses in Italy in 2019. Parents should be aware of the intussusception risk and symptoms to ensure prompt treatment. It is widely recognized that the vaccination benefits (large numbers of RV hospitalizations prevented) outweigh the risk. HRV introduction in Italy was supported by epidemiologic burden studies, healthcare provider opinions, and congress debates, which significantly contributed to implementation of RV universal routine infant vaccination in Italy.

Impact of Rotavirus Vaccine Introduction on Rotavirus Hospitalizations Among Children Under 5 Years of Age-World Health Organization African Region, 2008-2018.

Rotavirus is the leading cause of acute gastroenteritis (AGE) among children worldwide. Prior to rotavirus vaccine introduction, over one third of AGE hospitalizations in Africa were due to rotavirus. We describe the impact of rotavirus vaccines using data from the African Rotavirus Surveillance Network (ARSN). For descriptive analysis, we included all sites reporting to ARSN for any length of time between 2008 and 2018. For vaccine impact analysis, continuous surveillance throughout the year was required to minimize potential bias due to enrollment of partial seasons and sites had to report a minimum of 100 AGE cases per year. We report the proportion of rotavirus AGE cases by year relative to vaccine introduction, and the relative reduction in the proportion of rotavirus AGE cases reported following vaccine introduction. From 2008 to 2018, 97 366 prospectively enrolled hospitalized children <5 years of age met the case definition for AGE, and 34.1% tested positive for rotavirus. Among countries that had introduced rotavirus vaccine, the proportion of hospitalized AGE cases positive for rotavirus declined from 39.2% in the prevaccine period to 25.3% in the postvaccine period, a 35.5% (95% confidence interval [CI]: 33.7-37.3) decline. No declines were observed among countries that had not introduced the vaccine over the 11-year period. Rotavirus vaccine introduction led to large and consistent declines in the proportion of hospitalized AGE cases that are positive for rotavirus. To maximize the public health benefit of these vaccines, efforts to introduce rotavirus vaccines in the remaining countries in the region and to improve coverage should continue.

Sustained Declines in Age Group-Specific Rotavirus Infection and Acute Gastroenteritis in Vaccinated and Unvaccinated Individuals During the 5 Years Since Rotavirus Vaccine Introduction in England.

The introduction of an oral live-attenuated monovalent rotavirus vaccine (Rotarix®) into the UK infant immunization program in July 2013 was associated with large reductions in laboratory-confirmed rotavirus infections and hospitalizations due to acute gastroenteritis (AGE) within 12 months. Here we report the 5-year impact of the program in England. Individuals with laboratory-confirmed rotavirus infections during 2000-2018 and all-cause hospitalizations for AGE during 2007-2018 were identified using national electronic records. Age-specific incidence rate ratios (IRR) and estimated numbers of cases averted in each of the 5 postvaccination years were calculated. There were 206 389 laboratory-confirmed rotavirus infections and 3 657 651 hospitalizations for all-cause AGE. Reductions of 69-83% in laboratory-confirmed rotavirus infections in all age groups and 77-88% in infants aged <1 year in each of the 5 postvaccine years are reported, with 11 386-11 633 cases averted annually. All-cause AGE hospitalizations were reduced by 12-35% across all age-groups and by 25-48% in <1 year-olds in the 5 postvaccine years, with 24 474-49 278 hospitalizations averted annually. There was strong evidence of indirect (herd) protection, with at least 50% and up to 80% of the non-specific end point of all-cause gastroenteritis (AGE) hospitalizations averted being in unvaccinated age-groups, primarily older adults. Seasonal changes include a possible shift from annual to biennial peaks with lower peak incidence and longer seasons. There were large and sustained declines in both laboratory-confirmed rotavirus infections and AGE hospitalizations across all age groups in each of the 5 years since the introduction of the UK rotavirus program.

Evaluating the potential economic and health impact of rotavirus vaccination in 63 middle-income countries not eligible for Gavi funding: a modelling study

SummaryBackgroundMiddle-income countries (MICs) that are not eligible for funding from Gavi, the Vaccine Alliance, have been slow to adopt rotavirus vaccines. Few studies have evaluated the cost-effectiveness and benefit–risk of rotavirus vaccination in these settings. We aimed to assess the potential economic and health impact of rotavirus vaccination in 63 MICs not eligible for funding from Gavi.MethodsIn this modelling study, we estimated the cost-effectiveness and benefit–risk of rotavirus vaccination in 63 MICs not eligible to Gavi funding. We used an Excel-based proportionate outcomes model with a finely disaggregated age structure to estimate the number of rotavirus gastroenteritis cases, clinic visits, hospitalisations, and deaths averted by vaccination in children younger than 5 years over a 10-year period. We calculated cost-effectiveness ratios (costs per disability-adjusted life-years averted compared with no vaccination) and benefit–risk ratios (number of hospitalisations due to rotavirus gastroenteritis averted per excess hospitalisations due to intussusception). We evaluated three alternative vaccines available globally (Rotarix, Rotavac, and Rotasiil) and used information from vaccine manufacturers regarding anticipated vaccine prices. We ran deterministic and probabilistic uncertainty analyses.FindingsOver the period 2020–29, rotavirus vaccines could avert 77 million (95% uncertainty interval [UI] 51–103) cases of rotavirus gastroenteritis and 21 million (12–36) clinic visits, 3 million (1·4–5·6) hospitalisations, and 37 900 (25 900–55 900) deaths due to rotavirus gastroenteritis in 63 MICs not eligible for Gavi support. From a government perspective, rotavirus vaccination would be cost-effective in 48 (77%) of 62 MICs considered. The benefit–risk ratio for hospitalisations prevented versus those potentially caused by vaccination exceeded 250:1 in all countries.InterpretationIn most MICs not eligible for Gavi funding, rotavirus vaccination has high probability to be cost-effective with a favourable benefit–risk profile. Policy makers should consider this new evidence when making or revisiting decisions on the use of rotavirus vaccines in their respective countries.FundingBill & Melinda Gates Foundation.

Genotype Diversity before and after the Introduction of a Rotavirus Vaccine into the National Immunisation Program in Fiji.

The introduction of the rotavirus vaccine, Rotarix, into the Fiji National Immunisation Program in 2012 has reduced the burden of rotavirus disease and hospitalisations in children less than 5 years of age. The aim of this study was to describe the pattern of rotavirus genotype diversity from 2005 to 2018; to investigate changes following the introduction of the rotavirus vaccine in Fiji. Faecal samples from children less than 5 years with acute diarrhoea between 2005 to 2018 were analysed at the WHO Rotavirus Regional Reference Laboratory at the Murdoch Children’s Research Institute, Melbourne, Australia, and positive samples were serotyped by EIA (2005–2006) or genotyped by heminested RT-PCR (2007 onwards). We observed a transient increase in the zoonotic strain equine-like G3P[8] in the initial period following vaccine introduction. G1P[8] and G2P[4], dominant genotypes prior to vaccine introduction, have not been detected since 2015 and 2014, respectively. A decrease in rotavirus genotypes G2P[8], G3P[6], G8P[8] and G9P[8] was also observed following vaccine introduction. Monitoring the rotavirus genotypes that cause diarrhoeal disease in children in Fiji is important to ensure that the rotavirus vaccine will continue to be protective and to enable early detection of new vaccine escape strains if this occurs.

1386. Current Estimates of the Impact of Routine Childhood Immunizations in Reducing Vaccine-Preventable Diseases in the United States

BackgroundRoutine immunizations for children aged 10 years and younger in the United States (US) currently cover 14 diseases. Updated estimates of public health impact are needed, given changes in disease epidemiology, evolving recommendations, and the dynamic nature of compliance with the immunization schedule.MethodsPre-vaccine disease incidence was estimated before each routine vaccine was recommended, with average values across multiple years obtained directly from published literature or calculated based on disease surveillance data or annual case estimates from the published literature. Pre-vaccine incidence then was compared to current, post-vaccine incidence, which was generally calculated as average values over the most recent 5 years of available incidence data. Overall incidence estimates and estimates by age group were calculated. Differences in pre- and post-vaccine disease incidence rates were used to calculate the annual number of cases averted, based on 2019 US population estimates. This analysis did not separately estimate the proportion of disease incidence reduction that may be attributed to adult vaccines or booster doses.ResultsPost-vaccine disease incidence decreased overall and for all age groups across all diseases evaluated (Table 1). Decreases ranged from 17.4% for influenza to 100.0% for polio (Figure 1). Over 90% reduction in incidence was achieved for 10 of the 14 diseases evaluated (including reduction in incidence of rotavirus hospitalizations). Overall post-vaccine disease incidence estimates were highest for influenza, rotavirus, and varicella. Estimated annual cases averted by vaccination in 2019 ranged from 1,269 for tetanus to more than 4.2 million for varicella.Table 1. Pre- and Post-Vaccine Disease Incidence Estimates, Annual Cases, and 2019 Cases Averted, by Disease Figure 1. Percentage Reduction in Disease Incidence Post-Vaccine, by Disease ConclusionRoutine childhood immunization in the US continues to result in high, sustained reduction in disease across all vaccines and for all age groups evaluated.DisclosuresElizabeth M. La, PhD, RTI Health Solutions (Employee) Justin Carrico, BS, GlaxoSmithKline (Consultant) Sandra E. Talbird, MSPH, RTI Health Solutions (Employee) Ya-Ting Chen, PhD, Merck & Co., Inc. (Employee, Shareholder) Mawuli K. Nyaku, DrPh, Merck & Co. Inc. (Employee, Shareholder) Cristina Carias, PhD, Merck (Employee, Shareholder) Gary S. Marshall, MD, GlaxoSmithKline (Consultant, Scientific Research Study Investigator)Merck (Consultant, Scientific Research Study Investigator)Pfizer (Consultant, Scientific Research Study Investigator)Sanofi Pasteur (Consultant, Grant/Research Support, Scientific Research Study Investigator, Honorarium for conference lecture)Seqirus (Consultant, Scientific Research Study Investigator) Craig S. Roberts, PharmD, MPA, MBA, Merck & Co., Inc (Employee, Shareholder)

Impact of the Rotavirus Vaccination Program in Norway After Four Years With High Coverage.

Use of rotavirus vaccines worldwide since 2006 has led to a significant impact on the burden of rotavirus disease. However, only a third of European countries have introduced rotavirus vaccination in their immunization programs. In October 2014, rotavirus vaccination was introduced for Norwegian infants under strict age restrictions. Exclusive use of the monovalent rotavirus vaccine (RV1) and high vaccination coverage from the beginning enabled evaluation of the impact of this vaccine during the first 4 years after introduction. Prospective laboratory-based surveillance among children <5 years of age hospitalized for acute gastroenteritis at 5 Norwegian hospitals was used to assess the vaccine effectiveness of 2 vaccine doses against rotavirus hospitalization in a case-control study. We used community controls selected from the national population-based immunization registry, and test-negative controls recruited through hospital surveillance. We also assessed the vaccine impact by using time-series analysis of retrospectively collected registry data on acute gastroenteritis in primary and hospital care during 2009-2018. Vaccine effectiveness against rotavirus-confirmed hospitalization was 76% (95% confidence interval [CI]: 34%-91%) using test-negative controls, and 75% (95% CI: 44%-88%) using community controls. In the postvaccine period, acute gastroenteritis hospitalizations in children <5 years were reduced by 45% compared with the prevaccine years (adjusted incidence rate ratios 0.55; 95% CI: 0.49-0.61). Reduction in hospitalizations was also seen in cohorts not eligible for vaccination. Rates in primary care decreased to a lesser degree. Four years after introduction of rotavirus vaccination in the national childhood immunization program, we recorded a substantial reduction in the number of children hospitalized for acute gastroenteritis in Norway, attributable to a high vaccine effectiveness.

Diarrhea hospitalization costs among children

BackgroundFollowing a recommendation by the World Health Organization, Madagascar introduced rotavirus vaccine in 2014. Though national rotavirus vaccine coverage has remained <80%, rotavirus hospitalizations declined by 78%. Gavi, the Vaccine Alliance, has provided financial support for rotavirus vaccine, however the Malagasy government has increasing responsibility for the financial cost. MethodsIn this evaluation, we describe the direct medical, direct non-medical, and indirect cost of illness due to diarrhea among children <5 years old at a public pediatric referral hospital. A 3-part structured questionnaire was administered during and following the hospitalization and the child’s hospital record was reviewed. ResultsIn total, 96 children were included in this analysis. The median total cost of the illness was $156.00 (IQR: 104.00, 210.86) and the median direct medical cost was $107.22. Service delivery costs represented a median of 44% of the inpatient costs; medications and diagnostic tests represented a median of 28% and 20% of the total costs of the hospitalization, respectively. The median percentage of the total illness costs paid by the household was 67%. Among households with income of <$61/month, the median costs of the illness paid by the household were $78.55, representing a median of 168% of the household’s monthly expenses. Among households earning >$303/month, the median costs paid by the household were $147.30, representing a median of 53% of the household’s monthly expenses. Among all household income levels, caregivers commonly paid these bills from savings, borrowed money, and donations. ConclusionsOur findings will be useful in assessing the cost-effectiveness of rotavirus vaccine by decisionmakers. These results may also help hospital administrators and healthcare providers better understand the financial constraints of families.

Lessons Learned from Long-Term Assessment of Rotavirus Vaccination in a High-Income Country: The Case of the Rotavirus Vaccine Belgium Impact Study (RotaBIS).

IntroductionThe rotavirus (RV) vaccine Belgium Impact Study (RotaBIS) evaluated the vaccine effect on RV-related hospital care in children up to 5 years old over a period of 13 years. Different forces were identified that influence the reduction in hospital care. Our analysis aims to report on the current RotaBIS dataset and explore through model simulation whether, how, and when the results could have been improved.MethodsAs performed in previous assessments, this analysis evaluated RV-related events per year, per age group, RV nosocomial infections, hospitalization duration, and herd effect. It subsequently identified results that were surprising or unexpected. To know whether those data could have been improved through specific interventions, we developed a model with the forces acting on the disease transmission and the vaccine effect on RV-related hospital care. Scenario analysis of the forces should explain the current findings and identify ways to optimize the results.ResultsThe RotaBIS data show that annual RV-related hospital cases (n = 1345 pre-vaccination) dropped by 70% (95% confidence interval [CI] 66–74%) by year 5 (n = 395) after vaccine introduction, and by 84% (95% CI 79–89%) by year 10 (n = 217). The herd effect during the first year was limited to 14% extra gain. During the last 5 years, small disease increases were seen biennially. The simulation model indicates that higher vaccine coverage of the major transmitters during the peak season of the first year of vaccination could have reduced RV-related hospital care by nearly 90% at 5 and 10 years after vaccine introduction owing to a higher herd effect. The smaller peaks observed in recent years would have been dramatically reduced.ConclusionThe current RotaBIS data show a maintained reduction, around 76%, in RV hospitalization cases. Simulations show that these results could have been improved to an important extent with a more optimal initiation of the vaccination program.Trial registrationClinicalTrials.gov identifier, NCT01563146 and NCT01563159.Electronic supplementary materialThe online version of this article (10.1007/s40121-020-00345-y) contains supplementary material, which is available to authorized users.

Spatio-temporal impact of self-financed rotavirus vaccination on rotavirus and acute gastroenteritis hospitalisations in the Valencia region, Spain

BackgroundSeveral studies have shown a substantial impact of Rotavirus (RV) vaccination on the burden of RV and all-cause acute gastroenteritis (AGE). However, the results of most impact studies could be confused by a dynamic and complex space-time process. Therefore, there is a need to analyse the impact of RV vaccination on RV and AGE hospitalisations in a space-time framework to detect geographical-time patterns while avoiding the potential confusion caused by population inequalities in the impact estimations.MethodsA retrospective population-based study using real-world data from the Valencia Region was performed among children aged less than 3 years old in the period 2005–2016. A Bayesian spatio-temporal model was constructed to analyse RV and AGE hospitalisations and to estimate the vaccination impact measured in averted hospitalisations.ResultsWe found important spatio-temporal patterns in RV and AGE hospitalisations, RV vaccination coverage and in their associated adverted hospitalisations. Overall, ~ 1866 hospital admissions for RV were averted by RV vaccination during 2007–2016. Despite the low-medium vaccine coverage (~ 50%) in 2015–2016, relevant 36 and 20% reductions were estimated in RV and AGE hospitalisations respectively.ConclusionsThe introduction of the RV vaccines has substantially reduced the number of RV hospitalisations, averting ~ 1866 admissions during 2007–2016 which were space and time dependent. This study improves the methodologies commonly used to estimate the RV vaccine impact and their interpretation.

Rotavirus gastroenteritis hospitalization in children. Trends in Abruzzo Region, 2008-2018

Abstract Background Rotavirus is the most important cause of hospitalization for gastroenteritis and dehydration in children under 5 years old. In developed countries, it significantly affects public health in terms of costs and morbidity. Despites the availability of an effective vaccine, the coverage remains low in Italy. This study aimed to evaluate the epidemiological impact of rotavirus hospitalizations in Abruzzo, an Italian region, from 2008 to 2018. Methods Data were obtained from hospital discharge records of all Abruzzo hospitals. For the study, only the admissions due to rotavirus infection occurring in children aged 0 to 5 over the study period were taken into consideration. For each year, age-adjusted standardized hospitalization rates for rotavirus infection were calculated, and time trends were analyzed by joint point regression models. Results A total of 747 admissions were identified. During the study period, a significant increase of admissions was observed among children under 1 year of age (AAPC +9.8%, 95%CI 0.0;20.5, p &amp;lt; 0.001) and a significant decrease was observed among children between 2 and 3 years of age (AAPC -10.6%, 95%CI -20.0; -0.1, p &amp;lt; 0.001). Overall, the standardized rate increased (AAPC +5.2%, 95%CI -3.0;14.1, p = 0.2). Conclusions These results confirm that Rotavirus gastroenteritis has a heavy impact on pediatric hospitalization in Abruzzo Region. Subsequently, the study gives evidence of the need to improve vaccination coverage, in order to reduce morbidity and costs for the Italian healthcare system. Key messages In Abruzzo region, rotavirus gastroenteritis is a very important cause of morbidity and hospitalization in children under 5 years old. This study confirms the need of an improvement in vaccination coverage, that is the most effective mean to reduce the high morbidity, as well as the social and health costs.