The uptake of rotavirus vaccine and its effectiveness in preventing acute gastroenteritis in the community

We examined the uptake of rotavirus vaccine and its effectiveness in preventing acute gastroenteritis (AGE) in the community. Data on rotavirus vaccines purchases and AGE were extracted from the computerized database of a large health maintenance organization in Israel. The incidence of AGE requiring a physician visit during 2008-09 rotavirus season among vaccinated and non-vaccinated children were compared, and vaccine effectiveness was calculated as: (1 − Relative Risk) × 100. During the study period, the uptake of rotavirus vaccine (mostly monovalent) reached 55.1% (N = 19,108) of the studied cohort. The risk of AGE requiring a physician visit was 23.2% and 46.4% among vaccinated and unvaccinated children, respectively, yielding an effectiveness of 50.1% (95% CI: 47.5%, 52.6%). Rotavirus monovalent vaccine was highly effective in preventing AGE in the community.     

Acute gastroenteritis hospitalizations after implementation of universal mass vaccination against rotavirus

BackgroundEstonia implemented rotavirus universal mass vaccination (RV UMV) in July 2014. We aimed to describe changes in acute gastroenteritis (AGE) hospitalization during RV seasons before (2007–2013) and after (2015–2018) RV UMV and compare patient profile of hospitalized AGE patients aged 0–18 years during first two consecutive RV seasons 2015 vs 2016.MethodsWe described AGE hospitalization patterns pre-and post-vaccine era using Estonian Health Insurance Fund (HIF) database. During a two-year observational multicenter study in seven Estonian hospitals from 01st of February 2015 to 30th August 2016 we assessed patient profile of all patients who met pre-determined AGE criteria.ResultsIn post-vaccine era AGE hospitalization rate decreased from 10 to 8 per 1000 population (RR 0.81, 95% CI 0.79–0.83) compared to pre-vaccine era. Decreased RV seasonal activity, 81% (95% CI 77–84) and 55% (95% CI 52–58) reduction of rotavirus gastroenteritis (RVGE) hospitalization among age groups <1 and 1–4, respectively and upsurge of norovirus gastroenteritis (NoVGE) hospitalizations (RR = 1.8; 95% CI 1.6–1.9) was seen.In the multicenter observational study, among 2249 AGE patients hospitalized median age of RVGE patients increased from 2 to 3 years (p < 0.01) and duration of hospital stay decreased among RVGE, NoVGE and other GE patients during two consecutive RV seasons. According to Vesikari Clinical Severity Scoring System statistically significant change of severity score distribution in two RV seasons was seen (p < 0.001) with trend towards less severe AGE hospitalizations; 82.5% vs 70.5% severe cases in 2015 vs 2016, respectively.ConclusionRV UMV lead to immediate and sustainable reduction of hospitalizations due to RVGE in children aged <4 years and reduction of overall AGE accompanied with the decrease in the severity of hospitalized children.     

Long-term surveillance of rotavirus vaccination after implementation of a national immunization program in Finland (2008–2018)

BackgroundRotavirus (RV) vaccination was included in the Finnish National immunization Program (NIP) in 2009. RotaTeq (RV5) has been used exclusively with a national average vaccination coverage rate (VCR) of > 90%. While previous studies have demonstrated that inpatient rotavirus gastroenteritis (RVGE) admissions declined by as much as 96% in Finnish children ≤ 5 years old following RV vaccination introduction, no study has evaluated long-term protection after vaccination in Finland. In this study, we analyze incidence of hospital outpatient visits and inpatient admissions of gastroenteritis in children up to 7 years of age.MethodsWe first describe the incidence of RVGE, viral gastroenteritis (VGE), and acute gastroenteritis (AGE) for all Finnish children born during 2008–2011. Children were stratified by the year of birth into not-eligible, partially eligible and rotavirus vaccine-eligible (born in 2008, 2009, 2010 and 2011, respectively). Hospital inpatient and outpatient data was collected from the National Care Register for all children from birth until December 31st, 2018. We also studied RVGE incidence during 2014–2017 for children<3 years of age in municipalities with VCRs of 90% and above and municipalities with VCRs below 90%.ResultsRVGE incidence decreased significantly soon after implementation of RV vaccination in the NIP. In vaccine-eligible cohorts, no clear peak incidence in the youngest age groups could be observed, and no RVGE cases were observed beyond 6 years after vaccination, in contrast to vaccine ineligible and partially eligible cohorts. Despite an overall high VCR in Finland, regions with high VCR had lower incidence of RVGE than regions with lower VCR.ConclusionIncidence of RVGE has remained low in all age groups during the 10 years following introduction of RV vaccine in the Finnish NIP. Differences in RVGE incidence were observed in regions with high as compared with lower VCR, highlighting the importance of maintaining high vaccination coverage.     

Effects of rotavirus vaccine on all-cause acute gastroenteritis and rotavirus hospitalizations in Israel: A nationwide analysis

BackgroundIn December 2010, the pentavalent rotavirus vaccine (RotaTeq) was added to the national immunization program in Israel. The study aim was to examine national reductions in all-cause acute gastroenteritis (AGE) and rotavirus gastroenteritis (RVGE) hospitalizations among children aged 0–59 months following the introduction of universal rotavirus immunization in Israel.MethodsWe extracted data from the Israel National Hospital Discharge Database. Hospitalization rates were calculated by dividing the annual number of all-cause AGE and RVGE hospitalizations by the number of children aged 0–59 months residing Israel. To assess rate reductions, we compared the mean hospitalization rate for the pre-vaccine years (2002–2008) with that for the universal vaccination years (2011–2017). Interrupted time-series analyses were undertaken. During 2008–2010 rotavirus vaccines were partially available.ResultsA total of 131,116 AGE hospitalizations were reported, of which 13,111 (10.0%) were coded as RVGE hospitalizations. The average annual all-cause AGE hospitalization rate during the pre-vaccine period was 147.9 (95% CI 146.7–149.0) per 10,000 children aged 0–59 months, and declined by 38.7–53.0% during the universal vaccination years. The average annual pre-vaccine RVGE hospitalization rate was 16.9 (95% CI 16.5–17.3) per 10,000 children, and declined by 89.1% during 2016–2017.Findings from interrupted time-series analyses showed significant impact of introducing universal rotavirus immunization on the declines of all-cause AGE and RVGE hospitalizations rates. A multivariable Autoregressive Integrated Moving Average model showed that the variable “immunization period” was a significant predictor of RVGE hospitalizations (t = 7.3, p < 0.001) for the universal vaccination years.The declines in hospitalizations rates of all-cause AGE were lower among Arab children compared to Jewish children, but the declines in RVGE rates were similar between the groups.ConclusionsNational hospitalization data demonstrated substantial and consistent reductions in all-cause AGE and RVGE hospitalizations following the implementation of universal rotavirus vaccination program.     

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.     

Success of rotavirus vaccination in Finland,a register based study measuring impact beyond overall effectiveness

IntroductionEven with vaccines available since 2006, rotavirus continues to be a major cause of acute gastroenteritis globally in children under 5 years old. Finland introduced the rotavirus vaccine to its national vaccination programme in 2009. Since then hospitalizations due to gastroenteritis caused by rotavirus (RVGE) and of all causes (AGE) have been reduced significantly in young children.MethodsWe performed a retrospective analysis of data from register databases consisting of over 200 000 children aged 0.5-2 years. Children born before rotavirus vaccines were available (2002, 2003) and after the implementation of rotavirus vaccination programme (2014, 2015) were followed for episodes of acute infectious gastroenteritis. We calculated the incidences of hospital outpatient and inpatient episodes and used individual vaccination records to estimate the overall, total, direct and indirect vaccine effect (VE %).ResultsAmong children born in 2014 and 2015, there was a 96% reduction in inpatient RVGE episodes and a 78% reduction in episodes of inpatient AGE compared to the pre-vaccination era, comprising the overall VE. Direct effectiveness was 96% and 53% for RVGE and AGE respectively. Herd effect i.e. indirect protection was estimated to be 67% against inpatient RVGE and 56% against inpatient AGE. Protection acquired by the vaccinated children when compared to pre vaccination era i.e. the total VE was 99% for inpatient RVGE and 79% for inpatient AGE.ConclusionsAlthough overall incidences for every disease type studied were reduced, rotavirus is still circulating with seasonality and there is a slight shift of disease towards the older age groups. Together with changes observed in the distribution of rotavirus genotypes, our results indicate that continuous monitoring is still necessary.     

Effectiveness of rotavirus vaccine in preventing hospitalization due to rotavirus gastroenteritis in young children in Connecticut,USA

Rotavirus vaccine was recommended for use in US infants to prevent rotavirus gastroenteritis (RGE) in February 2006. This matched case control study assessed the effectiveness of rotavirus vaccine in preventing hospitalization of young. Cases were vaccine-eligible children 8 weeks-3 years of age, hospitalized due to laboratory-confirmed RGE. Cases (n = 42) were matched to 2 control groups: (a) hospitalized controls (n = 80): children hospitalized for reasons other than RGE, matched to the cases by age and time of presentation and (b) community controls (n = 73): non-hospitalized children matched by age and medical practice. Adjusted vaccine effectiveness against hospitalization with RGE in vaccine eligible children receiving at least one dose of vaccine was 94.3% (95% C.I.: 55.4%–99.3%; p = 0.006) for hospitalized controls and 96.9% (95% C.I.: 59.4%–99.8%; p = 0.008) for community controls.     

Impact of rotavirus vaccine on acute gastroenteritis in children under 5 years in Senegal: Experience of sentinel site of the Albert Royer Children's Hospital in Dakar

BackgroundAcute gastroenteritis (AGE) is a leading cause of morbidity and mortality among children <5 years of age in developing countries, with rotavirus being the most common infectious etiology. In November 2014, monovalent rotavirus vaccine was introduced in Senegal. We determined the impact of rotavirus vaccine on hospitalizations for all-cause and rotavirus related AGE in children <60 months of age.MethodsWe examined two data sources from the national referral hospital. Using sentinel surveillance data from March 2011 to February 2017, we examined the proportion of AGE hospitalizations among children <60 months of age attributable to rotavirus, stratified by age groups (0–11, 12–23 and 24–59 months). Using pediatric logbook data from March 2010 to February 2017, we examined the proportion of all childhood hospitalizations attributable to AGE, among the same age groups.ResultsIn sentinel surveillance, 673 patients <60 months were hospitalized for AGE, with 30% (203/673) due to rotavirus. In pre-vaccine years, the median proportion of rotavirus-positive hospitalizations was 42%; this proportion declined by 76% to 10% rotavirus positive in 2015–2016 (p < .001) and by 59% to 17% in 2016–2017 (p < .001). From the logbook data, among all children <60 months, a median of 11% of all hospitalizations in the pre-vaccine period were due to AGE, with 2015–2016 seeing a 16% decline (p < .001), to 9% of all hospitalizations, and 2016–2017 seeing a 39% decline (p < .001), to 7% of all hospitalizations. Declines in both rotavirus-associated and all-cause AGE hospitalizations were most marked among infants, with a suggestion of herd effect among older children seen in the surveillance data.ConclusionRotavirus vaccine demonstrated a significant impact on rotavirus-associated hospitalizations and all-cause AGE hospitalizations in the first two seasons after vaccine introduction in Senegal. Our data support the continued use of this vaccine in national immunization program.     

Use of the state immunization information system to assess rotavirus vaccine effectiveness in Connecticut, 2006-2008

Immunization information systems (IIS) contain individual vaccination records and have potential use for evaluating post-licensure vaccine effectiveness (VE). A matched case-control study was performed by using the Connecticut state IIS to calculate rotavirus VE against hospitalization; results were compared with pre-licensure efficacy and with estimates previously obtained by traditional case-control methods using matched controls from medical sources and medical chart abstracted data. Case-patients (n = 54) were vaccine-eligible children with IIS entry and hospitalized for rotavirus gastroenteritis during July 2006-December 2008; each was matched to five control subjects (n = 270) who were randomly selected from IIS based on case-patient's birth date and town of residence. VE of at least one dose was 90.6%, comparable to the pre-licensure efficacy of 96% and to the unadjusted 83.5-90.7% estimates by using traditional case-control methods. IIS can be a convenient and potentially accurate tool for calculating VE.     

Risk factors for nosocomial rotavirus infection in a paediatric hospital: The potential role for rotavirus vaccine use

To analyze the incidence and risk factors (RF) of nosocomial infection (NI) in a paediatric teaching hospital, a retrospective cohort study was conducted in Salvador, Brazil. The Centres for Disease Control and Prevention definitions were used. The detection of the rotavirus antigen in stool was performed using a rapid latex agglutination test. The study group comprised 2978 admissions that accounted for 32,924 patient-days. The incidence of NI was 8.3/1000 patient-days and 9.2/100 admissions. Of the 274 NI episodes, the most common illness and causative agent were gastroenteritis (125; 45.6%) and rotavirus (59; 21.5%), respectively. The RF for rotavirus NI was young age (10 ± 8 months vs. 27 ± 33 months; mean difference 17 months, 95% CI 15–20 months, p < 0.001). The temporal distribution of community-acquired and NI rotavirus showed similar trends. The universal use of rotavirus vaccine is a potential tool to control NI among children.     

First year experience of rotavirus immunisation programme in Finland

Introduction

This study aimed to estimate the impact of rotavirus (RV) immunisation programme on the total hospital treated acute gastroenteritis (AGE) burden, as well as, on severe RV disease burden in Finland during the first year after immunisation programme introduction. Such studies can also be considered as a vaccine-probe-study, where unspecific disease burden prevented by immunisation is assumed to be caused by the agent the vaccine is targeted against.

Methods

The RV related outcome definitions were based on data registered in the National Hospital Discharge Register coded using ICD 10 codes. Incidences of hospitalised and hospital outpatient cases of AGE and RVGE were compared prior (1999–2005) and after (2010) the start of the programme among children under 5 years of age. ICD 10 codes utilised were A00-A09, R11 and K52.

Results

The reductions in disease burden, when the post-introduction year was compared to pre-vaccine era, were 80.3% (95% CI 74.5–84.7) in hospital inpatient RVGE among toddlers less than 1 year of age and 53.9% (95% CI 49.8–57.7) when the total inpatient AGE burden was considered in the same age group. For the corresponding hospital outpatient cases the reductions were 78.8% (95% CI 48.4–91.3) and 12.5% (7.1–17.7). The overall vaccine impact against confirmed RVGE in age cohorts eligible for vaccination before the RV season 2010 was 97% (95% CI 90.7–99.0). If the total reductions, both in diagnosed RVGE, as well as in cases without definite microbial diagnosis, were expected to be RVGE, population based estimates for the total disease burden can be obtained: for inpatient RVGE in children less than 1 year of age the estimate is 10.5/1000 pyrs, while the diagnosed specific incidence was less than half of that, 4.9/1000 pyrs.

Discussion

During the first post-vaccination year 2010, RV immunisation programme clearly managed to control the severe, hospital treated, forms of RVGE. The total disease burden is a more valuable end point than mere diagnosed cases as laboratory confirmation practises change after vaccine introduction. Our study is limited by the very short post-introduction follow up.     

儿童轮状病毒胃肠炎免疫预防专家共识(2020版)

A组轮状病毒(Group A rotavirus,RV)是引起中国<5岁儿童重度胃肠炎和死亡的主要病原之一。接种RV疫苗是预防控制儿童轮状病毒胃肠炎(Rotavirus gastroenteritis,RVGE)的最有效措施。本共识通过回顾RV相关文献,结合中国RV疾病监测数据、世界卫生组织(World Health Organization,WHO)RV疫苗立场文件和专家研讨意见编写而成,旨在为中国儿童RV疫苗使用提供相关科学信息,供专业技术人员在相关工作中参考使用,为制定中国儿童RVGE免疫预防策略提供循证依据。     

The effect of rotavirus immunization on rotavirus gastroenteritis hospitalization rates in military dependents

We conducted a retrospective review of all U.S. military dependents less than 5 years old hospitalized with rotavirus-associated gastroenteritis from July 2003 to June 2009. The two post-vaccine seasons showed a significant reduction of 62.4% (95% CI, 58.6-65.8, P < 0.001) in rotavirus gastroenteritis hospitalization rate compared to the three pre-vaccine seasons. Infants less than 12 months old showed the greatest reduction in incidence at 75.3%. A substantial decrease was also seen in unvaccinated children as well. Vaccine efficacy against hospitalization was 86.0% (95% CI, 77.7-91.3) after just a single dose. The overwhelming majority of children hospitalized for rotavirus since the introduction of the vaccine (ranging from 91.8 to 100% per season) had not received any of the rotavirus vaccine series.     

Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized,double-blind,placebo-controlled trial

BackgroundA randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RotaTeq™, RV5) against rotavirus gastroenteritis (RVGE).Methods4040 participants aged 6–12 weeks were enrolled and randomly assigned to either 3 oral doses of RV5 (n = 2020) or placebo (n = 2020), administered ∼4 weeks apart. The participants also received OPV and DTaP in a concomitant or staggered fashion. The primary objective was to evaluate vaccine efficacy (VE) against naturally-occurring RVGE at least 14 days following the third dose. Key secondary objectives included: VE against naturally-occurring severe RVGE and VE against severe and any-severity RVGE caused by rotavirus serotypes contained in the vaccine, occurring at least 14 days after the third dose. All adverse events (AEs) were collected for 30 days following each dose. Serious AEs (SAEs) and intussusception cases were collected during the entire study. (ClinicalTrials.gov registry: NCT02062385).ResultsVE against RVGE of any-severity caused by any serotype was 69.3% (95% CI: 54.5, 79.7). The secondary efficacy analysis showed an efficacy of: 78.9% (95% CI: 59.1, 90.1) against severe RVGE caused by any serotype; 69.9% (95% CI: 55.2, 80.3) and 78.9% (95% CI: 59.1, 90.1) against any-severity and severe RVGE caused by serotypes contained in the vaccine, respectively. Within 30 days following any vaccination, 53.5% (1079/2015) and 53.3% (1077/2019) of participants reported at least one AE, and 5.8% (116/2015) and 5.7% (116/2019) reported SAEs in the vaccine and placebo groups, respectively. No SAEs were considered vaccine-related in recipients of RV5. Two intussusception cases were reported in recipients of RV5 who recovered after receiving treatment. Neither was considered vaccine-related.ConclusionsIn Chinese infants, RV5 was efficacious against any-severity and severe RVGE caused by any serotype and generally well-tolerated with respect to AEs.     

Impact and effectiveness of pentavalent rotavirus vaccine in children <5 years of age in Burkina Faso

BackgroundBurkina Faso was one of the first African nations to introduce pentavalent rotavirus vaccine (RV5, RotaTeq) into its national immunization program in October 2013. We describe the impact and effectiveness of rotavirus vaccine on acute gastroenteritis (AGE) hospitalizations among Burkinabe children.MethodsSentinel hospital-based surveillance for AGE was conducted at four hospitals during December 2013 – February 2017. Demographic, clinical, and vaccination information was collected and stool specimens were tested by EIA. Trends in rotavirus AGE hospitalizations and changes in the proportion of AGE hospitalizations due to rotavirus were examined at two sentinel sites from January 2014 – December 2016. Unconditional logistic regression models using data from all 4 surveillance sites were used to calculate vaccine effectiveness (VE, defined as 1-odds ratio) by comparing the odds of vaccination among rotavirus AGE (cases) and non-rotavirus AGE (controls) patients, controlling for age, season, hospital site and socioeconomic factors.ResultsThe proportion of AGE hospitalizations that tested positive for rotavirus declined significantly among children <5 years of age, from 36% (154/422) in 2014 to 22% (71/323, 40% reduction, p < .01) in 2015 and 20% (61/298, 44% reduction, p < .01) in 2016. Among infants, the percentage of AGE admissions due to rotavirus fell significantly from 38% (94/250) in 2014 to 21% (32/153, 44% reduction, p < .01) in 2015 and 17% (26/149, 54% reduction, p < .01) in 2016. The adjusted VE for full 3-dose series of RV5 against rotavirus hospitalization was 58% (95% [CI], 10%, 81%) in children 6–11 months of age and 19% (−78%, 63%) in children ≥12 months.ConclusionRotavirus hospitalizations declined after introduction of pentavalent rotavirus vaccine in children, particularly among infants. RV5 significantly protected against severe rotavirus gastroenteritis in infants, but effectiveness decreased in older children.     

Association between mixed rotavirus vaccination types of infants and rotavirus acute gastroenteritis

IntroductionRotavirus remains the leading cause of severe diarrhea in children under 5 years worldwide. In the US, Rotarix^® (RV1) and RotaTeq^® (RV5), have been associated with reductions in and severity of rotavirus disease. Studies have evaluated the impact of RV1 or RV5 but little is known about the impact of incomplete or mixed vaccination upon vaccine effectiveness.MethodsCase control study to examine association of combined RV1 and RV5 and rotavirus acute gastroenteritis, factoring severity of diarrheal disease. Children born after March 1, 2009 with acute gastroenteritis from three pediatric hospitals in Atlanta, Georgia were approached for enrollment. Survey was administered, stool specimen was collected, and vaccination records were obtained.Results891 of 1127 children with acute gastroenteritis were enrolled. Stool specimens were collected from 708 for rotavirus testing; 215 stool samples tested positively for rotavirus. Children >12 months of age were more likely to have rotavirus. Children categorized with Vesikari score of >11 were almost twice as likely to be rotavirus positive. Prior rotavirus vaccination decreased the mean Vesikari score, p < 0.0001. Children with complete single type vaccination were protected against rotavirus (OR 0.21, 95% CI: 0.14–0.31, p < 0.0001).ConclusionComplete rotavirus vaccination with a single vaccine type resulted in protection against rotavirus diarrhea and decrease in severity of rotavirus gastroenteritis. Incomplete rotavirus vaccination either with a single vaccine or mixed vaccination types also provided some protection.     

Impact of five years of rotavirus vaccination in Finland – And the associated cost savings in secondary healthcare

IntroductionThis study aimed to estimate the impact of the national rotavirus (RV) vaccination programme, starting 2009, on the total hospital-treated acute gastroenteritis (AGE) and severe RV disease burden in Finland during the first five years of the programme. This study also evaluated the costs saved in secondary healthcare by the RV vaccination programme.MethodsThe RV related outcome definitions were based on ICD10 diagnostic codes recorded in the Care Register for Health Care. Incidences of hospitalised and hospital outpatient cases of AGE (A00-A09, R11) and RVGE (A08.0) were compared prior (1999–2005) and after (2010–2014) the start of the programme among children less than five years of age.ResultsThe reduction in disease burden in 2014, when all children under five years of age have been eligible for RV vaccination, was 92.9% (95%CI: 91.0%–94.5%) in hospitalised RVGE and 68.5% (66.6%–70.3%) in the total hospitalised AGE among children less than five years of age. For the corresponding hospital outpatient cases, there was a reduction of 91.4% (82.4%–96.6%) in the RVGE incidence, but an increase of 6.3% (2.7%–9.9%) in the AGE incidence. The RV vaccination programme prevented 2206 secondary healthcare AGE cases costing €4.5 million annually. As the RV immunisation costs were €2.3 million, the total net savings just in secondary healthcare costs were €2.2 million, i.e. €33 per vaccinated child.DiscussionThe RV vaccination programme clearly controlled the severe, hospital-treated forms of RVGE. The total disease burden is a more valuable end point than mere specifically diagnosed cases as laboratory confirmation practises usually change after vaccine introduction. The RV vaccination programme annually pays for itself at least two times over.     

Sustained impact of rotavirus vaccine on rotavirus hospitalisations in Lusaka,Zambia, 2009–2016

BackgroundMonovalent rotavirus vaccine (RV1) was introduced in Lusaka in February 2012 and rolled out countrywide in November 2013 in the routine Expanded Programme on Immunisation and administered at 6 and 10 weeks with no catch up dose. Reported here is the monitoring of rotavirus acute gastroenteritis hospitalisations at the University Teaching Hospital, Lusaka, Zambia as part of efforts to document the impact of rotavirus vaccine.MethodsChildren <5 years hospitalised for acute gastroenteritis (AGE) from January 2009 to December 2016 were recruited into the rotavirus disease burden active surveillance and had their stools tested for rotavirus by enzyme immunoassay. We compared rotavirus-associated AGE hospitalisations of the pre-vaccine era (2009–2011) with the post-rotavirus vaccine introduction period (2013–2016).ResultsWith the increase in RV1 coverage in Lusaka, rotavirus AGE declined significantly from 40% of diarrhoea hospitalisation in the pre-vaccine era to 29% of diarrhoea hospitalisation in the post-vaccine era (p < 0.001) in children <5 years. After a decreasing trend in rotavirus positivity from 2013 to 2015, positivity increased to 37% in 2016. However, the post-vaccine years (2012–2016) saw substantial decline in the number tested (median decline: 34% (range: 20–43%)) and the number of positive results (median decline: 52% (range: 30–65%).ConclusionA sustained and significant decline in rotavirus AGE hospitalisations was observed in children <5 years since the introduction of RV1 in Lusaka, Zambia. Despite an increase in rotavirus positivity in 2016, the total number of children enrolled and the number of rotavirus positive children remained below baseline. The reason for the increase in rotavirus positivity in 2016 is unknown but could be due to an accumulation of susceptible children and the shifting of disease to children of older age groups. This finding underscores the need for continued monitoring of rotavirus vaccine impact.     

RotaTeq,a pentavalent rotavirus vaccine: Efficacy and safety among infants in Europe

A pentavalent human–bovine reassortant oral rotavirus vaccine, RotaTeq^®, was evaluated among nearly 70,000 infants in the Rotavirus Efficacy and Safety Trial (REST), of which 30,523 were from Europe. All infants were followed for serious adverse events as well as hospitalizations and emergency department (ED) visits. All adverse events, health care utilization, and RVGE regardless of severity were evaluated in the clinical efficacy cohort (N = 2686) in Finland. RotaTeq^® was 98.3% (95% CI, 90.2–100%) and 68.0% (95% CI 60.3–74.4%) efficacious against severe rotavirus gastroenteritis (RVGE) and all RVGE due to any serotype for two rotavirus seasons post-vaccination. The combined rate of hospitalizations and ED visits due to RVGE of any serotype was reduced by 94.5% (95% CI, 91.3–96.8%) for up to 2 years after vaccination. There were no statistically significant differences between RotaTeq^® and placebo for any of the safety outcomes. In Europe, RotaTeq^® was highly efficacious and well tolerated.