Abstract
BackgroundRotaTeq™ (RV5; Merck & Co. Inc., USA) and Rotarix™ (RV1, GlaxoSmithKline, Belgium) vaccines, developed to prevent rotavirus diarrhea in children under five years old, were both introduced into national immunization programs in 2006. As many countries in Latin America and the Caribbean have included either RV5 or RV1 in their routine childhood vaccination programs, we conducted a systematic review and meta-analysis to analyze efficacy, safety and effectiveness data from the region.MethodsWe conducted a systematic search in PubMed, EMBASE, Scielo, Lilacs and the Cochrane Central Register, for controlled efficacy, safety and effectiveness studies published between January 2000 until December 2011, on RV5 and RV1 across Latin America (where both vaccines are available since 2006). The primary outcome measures were: rotavirus-related gastroenteritis of any severity; rotavirus emergency department visits and hospitalization; and severe adverse events.ResultsThe results of the meta-analysis for efficacy show that RV1 reduced the risk of any-severity rotavirus-related gastroenteritis by 65% (relative risk (RR) 0.35, 95% confidence interval (CI) 0.25; 0.50), and of severe gastroenteritis by 82% (RR 0.18, 95%CI 0.12; 0.26) versus placebo. In trials, both vaccines significantly reduced the risk of hospitalization and emergency visits by 85% (RR 0.15, 95%CI 0.09; 0.25) for RV1 and by 90% (RR 0.099, 95%CI 0.012; 0.77) for RV5. Vaccination with RV5 or RV1 did not increase the risk of death, intussusception, or other severe adverse events which were previously associated with the first licensed rotavirus vaccine. Real-world effectiveness studies showed that both vaccines reduced rotavirus hospitalization in the region by around 45–50% for RV5 (for 1 to 3 doses, respectively), and, by around 50–80% for RV1 (for 1 to 2 doses, respectively). For RV1, effectiveness against hospitalization was highest (around 80–96%) for children vaccinated before 12 months of age, compared with 5–60% effectiveness in older children. Both vaccines were most effective in preventing more severe gastroenteritis (70% for RV5 and 80–90% for RV1) and severe gastroenteritis (50% for RV5 and 70–80% for RV1).ConclusionThis systematic literature review confirms rotavirus vaccination has been proven effective and well tolerated in protecting children in Latin America and the Caribbean.
Highlights
We carried out a systematic review and meta-analysis to describe, compare and summarize the vaccine efficacy, from pre-licensure randomized clinical trials, and vaccine effectiveness, from post-licensure comparative observational studies, of RV5 and RV1, in preventing rotavirus gastroenteritis and reducing hospitalization and emergency visits across Latin American countries, where both vaccines have been available for the last decade
Safety data of RV5 and RV1 were collected to assess the risk of intussusception, severe adverse events or death potentially associated with vaccination
The benefits from rotavirus vaccination greatly exceed the risk of intussusception, especially in developing regions such as Latin America
Summary
RotaTeqTM (RV5; Merck & Co. Inc., USA) and RotarixTM (RV1, GlaxoSmithKline, Belgium) vaccines, developed to prevent rotavirus diarrhea in children under five years old, were both introduced into national immunization programs in 2006. An estimated 2.5 billion children suffer from diarrheal diseases and 1.5 million children die worldwide from diarrhea every year. Approximately one third of fatal diarrheal cases, estimated in 2008 as 453,000 children per year, mostly in less developed countries [3] and 40% of hospital admissions, due to diarrhea among children under five years of age, were caused by rotaviruses [1]. In developing countries, three-quarters of children suffer their first rotavirus diarrhea episode before 12 months of age [4]. Several studies have shown that immunization helps to reduce the number of diarrheaassociated deaths by preventing rotavirus infections or by reducing their severity [6]
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