Efficacy, safety and effectiveness of licensed rotavirus vaccines: a systematic review and meta-analysis for Latin America and the Caribbean

Abstract

Background RotaTeq™ (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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12887-016-0771-y) contains supplementary material, which is available to authorized users.

Global impact of rotavirus vaccine introduction on rotavirus hospitalisations among children under 5 years of age, 2008–16: findings from the Global Rotavirus Surveillance Network

“…This decline among Gaviineligible countries might result from the higher vaccine efficacy and effectiveness reported in highincome versus lowerincome settings. 33 As expected, in countries and regions that had not introduced rotavirus vaccine during the surveillance period analysed, we found a stable burden of rotavirus disease.…”

Universal rotavirus vaccination program in Sicily: Reduction in health burden and cost despite low vaccination coverage

“…19 A slight increase in intussusception cases among vaccinated children, usually after the first dose, has been reported in other studies but are outweighed by the benefits of RV vaccination, i.e., the reduction in RVGE hospitalizations and RVGE severity. 20 , 21 Moreover, Italian data on intussusception in the absence of RV vaccination, as well as a study conducted in Sicily before RV vaccination was introduced, showed a similar increasing trend in intussusception among children aged 12–59 months, indicating a role of other risk factors for intussusception. 22-26 …”

Клинико-Эпидемиологические Особенности Течения Ротавирусной Инфекции И Обоснование Ее Профилактики У Детей

“…Вакцини Rotarixі RotaTeq мають доведену тривалу статистично значиму ефективність (діють на велику кількість серотипів ротавірусів) та добру переносимість [32,28,24,20,31]. Саме тому Всесвітня організація охорони здоров'я (ВООЗ) рекомендує вакцинацію для профілактики та контролю ротавірусних інфекцій та включення її в усі імунізаційні програми національного рівня [14].…”