Vaccines for preventing rotavirus diarrhoea: vaccines in use
ABSTRACT Rotavirus results in more diarrhoea-related deaths in children less than five years of age than any other single agent in low- and middle-income countries. It is also a common cause of diarrhoea-related hospital admissions in high-income countries. The World Health Organization (WHO) recommends that all children should be vaccinated with a monovalent rotavirus vaccine (RV1; Rotarix, GlaxoSmithKline Biologicals) or a pentavalent rotavirus vaccine (RV5; RotaTeq, Merck & Co., Inc.), with a stronger recommendation for countries where deaths due to diarrhoea comprise more than 10% of all deaths. Lanzhou lamb rotavirus vaccine (LLR; Lanzhou Institute of Biomedical Products) is used in China only.
To evaluate rotavirus vaccines approved for use (RV1, RV5, and LLR) for preventing rotavirus diarrhoea. Secondary objectives were to evaluate the efficacy of rotavirus vaccines on all-cause diarrhoea, hospital admission, death, and safety profiles.
For this update, we searched MEDLINE (via PubMed) in October 2011, and in June 2011 we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (published in The Cochrane Library 2011, Issue 2), , EMBASE, LILACS, and BIOSIS. We also searched the ICTRP (28 June 2011) and checked reference lists of identified studies.
We selected randomized controlled trials in children comparing rotavirus vaccines approved for use with placebo, no intervention, or another vaccine.
Two authors independently assessed trial eligibility, extracted data, and assessed risk of bias. They combined dichotomous data using the risk ratio (RR) and 95% confidence intervals (CI) and used GRADE to evaluate evidence quality, which was reflected as follows: high quality ("vaccine prevents..."); moderate quality ("vaccine probably prevents..."); or low quality ("vaccine may prevent...").
Forty-three trials, including nine new trials for this update, met the inclusion criteria and enrolled 190,551 participants. Thirty-one trials assessed RV1, and 12 trials evaluated RV5. We did not find any trials assessing LLR.In children aged less than one year, RV1, compared to placebo, probably prevents 70% of all cases of rotavirus diarrhoea (RR 0.30, 95% CI 0.18 to 0.50; seven trials, 12,130 participants; moderate-quality evidence), and 80% of severe rotavirus diarrhoea cases (RR 0.20, 95% CI 0.11 to 0.35; seven trials, 35,004 participants; moderate-quality evidence). Similarly, RV5 prevents 73% of all rotavirus diarrhoea cases (RR 0.27, 95% CI 0.22 to 0.33; four trials, 7614 participants; high-quality evidence), and 77% of severe rotavirus diarrhoea cases (RR 0.23, 95% CI 0.08 to 0.71; three trials, 6953 participants; high-quality evidence). Both vaccines prevent over 80% of rotavirus diarrhoea cases that require hospitalization. For all-cause diarrhoea, based on two multi-centred trials from South Africa, Malawi, and Europe, RV1 may reduce severe cases by 42% (RR 0.58, 95% CI 0.40 to 0.84; two trials, 8291 participants; low--quality evidence). Also, based on one trial from Finland, RV5 may reduce severe cases by 72% (RR 0.28, 95% CI 0.16 to 0.48; one trial, 1029 participants; low-quality evidence).During the second year of life, compared to placebo, RV1 probably prevents 70% of all cases of rotavirus diarrhoea of any severity (RR 0.30, 95% CI 0.21 to 0.43; six trials, 8041 participants; moderate-quality evidence), and 84% of severe rotavirus diarrhoea cases (RR 0.16, 95% CI 0.12 to 0.21; eight trials, 32,854 participants; moderate-quality evidence). RV5 prevents 49% of all rotavirus diarrhoea cases of any severity (RR 0.51, 95% CI 0.36 to 0.72; four trials, 9784 participants; high-quality evidence), and 56% of severe rotavirus diarrhoea cases (RR 0.44, 95% CI 0.22 to 0.88; four trials, 9783 participants; high-quality evidence). For all-cause diarrhoea, RV1 probably reduces severe cases by 51% (RR 0.49, 95% CI 0.40 to 0.60; two trials, 6269 participants; moderate-quality evidence), and RV5 showed no difference with placebo (three trials, 8533 participants).Reported serious adverse events (including intussusception) after vaccination were measured in 95,178 children for RV1 and 77,480 for RV5, with no difference between the vaccines.
RV1 and RV5 vaccines are effective in preventing rotavirus diarrhoea. These data support the WHO's global vaccine recommendation. The potential for reduced vaccine efficacy in low-income countries needs to be investigated. No increased risk of intussusception was detected, but surveillance monitoring studies are probably advisable in countries introducing the vaccine nationally.
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ABSTRACT: Rotavirus (RV) is a leading cause of severe gastroenteritis (GE) in children across the world. As there is a lack of epidemiological data for RV gastroenteritis (RVGE) in Saudi Arabia, this hospital-based study was designed to estimate the disease burden of RVGE and assess the prevalent RV types in Saudi children younger than 5 years of age. Children hospitalized for acute GE were enrolled at four pediatric referral hospitals in Saudi Arabia. The study was conducted from February 2007 to March 2008 and used the World Health Organization's generic protocol for RVGE surveillance. The Vesikari severity scale was used to assess the severity of RVGE. Stool samples were tested for RV using an enzyme-linked immunosorbent assay. Samples were further typed by reverse transcriptase-polymerase chain reaction and hybridization assay for determining the G and P types. A total of 1,007 children were enrolled; the final analysis included 970 children, of whom 395 were RV positive, 568 were RV negative, and seven had unknown RV status. The proportion of RVGE among GE hospitalizations was 40.7% (95% confidence interval: 37.6-43.9). The highest percentage of RVGE hospitalizations (83.1%) was seen in children younger than 2 years of age. The highest proportion of RV among GE hospitalizations was in June 2007 with 57.1%. The most common RV types detected were G1P (49.3%), G1G9P (13.2%), and G9P (9.6%). Before hospitalization, severe GE episodes occurred in 88.1% RV-positive and 79.6% RV-negative children. Overall, 94% children had recovered by the time they were discharged. Two children (one RV positive and one RV negative) died due to GE complications. RVGE is responsible for a high proportion of hospitalizations in Saudi children younger than 5 years of age. Routine RV vaccination has therefore been introduced into the national immunization program and may help reduce the morbidity, mortality, and disease burden associated with RVGE in Saudi Arabia.Clinical Epidemiology 01/2015; 7:129-37. DOI:10.2147/CLEP.S69502
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ABSTRACT: Vaccination programmes are implemented either as new vaccines become available or evidence about them accumulates, or in response to specific situations. In the United Kingdom, development and implementation of the national immunisation programme is centrally coordinated and funded by the Department of Health on behalf of England, Wales, Scotland and Northern Ireland. A number of significant changes were made to the UK immunisation schedule for 2013/2014. Three new vaccines were introduced: intranasal influenza and oral rotavirus for children and subcutaneous shingles for older adults. To ensure protection against meningococcal C infection into adulthood, there has been a change to the schedule for meningitis C vaccination. The temporary pertussis vaccination programme for pregnant women, set up in response to an increase in the number of cases of pertussis particularly among young babies, has been extended until further notice. Furthermore, in response to large outbreaks of measles in south Wales and other parts of the UK, a national measles, mumps and rubella catch-up campaign specifically targeted at unvaccinated children aged 10-16 years was launched to ensure that all children and young people have received two doses of measles, mumps and rubella vaccine. This review describes the rationale behind these policy changes.04/2015; 6(4):2054270415577762. DOI:10.1177/2054270415577762
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ABSTRACT: Background Globally, diarrhoea is the second leading cause of morbidity and mortality, responsible for the annual loss of about 10% of the total global childhood disease burden. In Tanzania, Rotavirus infection is the major cause of severe diarrhoea and diarrhoeal mortality in children under five years. Immunisation can reduce the burden, and Tanzania added rotavirus vaccine to its national immunisation programme in January 2013. This study explores the cost effectiveness of introducing rotavirus vaccine within the Tanzania Expanded Programme on Immunisation (EPI). Methods We quantified all health system implementation costs, including programme costs, to calculate the cost effectiveness of adding rotavirus immunisation to EPI and the existing provision of diarrhoea treatment (oral rehydration salts and intravenous fluids) to children. We used ingredients and step down costing methods. Cost and coverage data were collected in 2012 at one urban and one rural district hospital and a health centre in Tanzania. We used Disability Adjusted Life Years (DALYs) as the outcome measure and estimated incremental costs and health outcomes using a Markov transition model with weekly cycles up to a five-year time horizon. Results The average unit cost per vaccine dose at 93% coverage is US$ 8.4, with marked difference between the urban facility US$ 5.2; and the rural facility US$ 9.8. RV1 vaccine added to current diarrhoea treatment is highly cost effective compared to diarrhoea treatment given alone, with incremental cost effectiveness ratio of US$ 112 per DALY averted, varying from US$ 80–218 in sensitivity analysis. The intervention approaches a 100% probability of being cost effective at a much lower level of willingness-to-pay than the US$609 per capita Tanzania gross domestic product (GDP). Conclusions The combination of rotavirus immunisation with diarrhoea treatment is likely to be cost effective when willingness to pay for health is higher than USD 112 per DALY. Universal coverage of the vaccine will accelerate progress towards achievement of the child health Millennium Development Goals.Cost Effectiveness and Resource Allocation 04/2015; 13(1). DOI:10.1186/s12962-015-0033-0 · 0.87 Impact Factor