title: Efficacy, safety and effectiveness of licensed rotavirus vaccines: a systematic review and meta-analysis for Latin America and the Caribbean.
abstract: 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.
  
  
  
  We 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.
  
  
  
  The 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).
  
  
  
  This systematic literature review confirms rotavirus vaccination has been proven effective and well tolerated in protecting children in Latin America and the Caribbean.
authors.affiliation: Unidad de Investigación Médica en Enfermedades Infecciosas, Hospital de Pediatría, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.
authors.forename: Raúl F
authors.initials: RF
authors.lastname: Velázquez
authors.affiliation: Instituto Evandro Chagas, Secretaria de Vigilância em Saúde, Virology Section, Av. Almirante Barroso 492, 66.090-000, Belém, Pará, Brazil. alexandrelinhares@iec.pa.gov.br.
authors.forename: Alexandre C
authors.initials: AC
authors.lastname: Linhares
authors.affiliation: Centro de Excelencia Capacitación, Investigación y Gestión para la Salud basada en Evidencias CIGES, Universidad de La Frontera, Temuco, Chile.
authors.forename: Sergio
authors.initials: S
authors.lastname: Muñoz
authors.affiliation: Centro de Excelencia Capacitación, Investigación y Gestión para la Salud basada en Evidencias CIGES, Universidad de La Frontera, Temuco, Chile.
authors.forename: Pamela
authors.initials: P
authors.lastname: Seron
authors.affiliation: Centro de Excelencia Capacitación, Investigación y Gestión para la Salud basada en Evidencias CIGES, Universidad de La Frontera, Temuco, Chile.
authors.forename: Pedro
authors.initials: P
authors.lastname: Lorca
authors.affiliation: GSK Vaccines, Panamá City, Panamá.
authors.forename: Rodrigo
authors.initials: R
authors.lastname: DeAntonio
authors.affiliation: GSK Vaccines, Panamá City, Panamá.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Ortega-Barria
mesh_terms: D017691:Caribbean Region / Q000453:epidemiology; D006801:Humans; D007843:Latin America / Q000453:epidemiology; D015233:Models, Statistical; D012400:Rotavirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000009:adverse effects; D016896:Treatment Outcome; D014613:Vaccines, Attenuated / Q000009:adverse effects
chemical_list: C492457:RIX4414 vaccine; C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: Diarrhea; Effectiveness; Efficacy; Gastroenteritis; Hospitalization; RV1; RV5; Rotavirus; Safety; Vaccination