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Meta-Analysis
. 2017 Jan 13;17(1):14.
doi: 10.1186/s12887-016-0771-y.

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

Affiliations
Meta-Analysis

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

Raúl F Velázquez et al. BMC Pediatr. .

Abstract

Background: 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. 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.

Methods: 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.

Results: 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).

Conclusion: This systematic literature review confirms rotavirus vaccination has been proven effective and well tolerated in protecting children in Latin America and the Caribbean.

Keywords: Diarrhea; Effectiveness; Efficacy; Gastroenteritis; Hospitalization; RV1; RV5; Rotavirus; Safety; Vaccination.

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Figures

Fig. 1
Fig. 1
PRISMA flow chart: rotavirus vaccine efficacy and safety. Combined PRISMA* flow chart for the systematic review to evaluate rotavirus vaccine efficacy and safety in countries from Latin America and the Caribbean
Fig. 2
Fig. 2
Forest plot: Hospitalization or emergency visits for rotavirus gastroenteritis in trials. Forest plot of meta-analysis for hospitalization or emergency unit visit due to rotavirus gastroenteritis in trials. Rotavirus vaccination vs. placebo: relative risk for requiring hospitalization or emergency unit visit due to rotavirus gastroenteritis
Fig. 3
Fig. 3
Forest plot: Severe diarrhea, rotavirus gastroenteritis (any severity) and severe rotavirus gastroenteritis in trials. Forest plot of meta-analysis for preventing rotavirus gastroenteritis of any severity in trials. Rotavirus vaccination vs. placebo: relative risk for protecting against rotavirus gastroenteritis of any severity or severe rotavirus gastroenteritis
Fig. 4
Fig. 4
PRISMA flow chart: rotavirus vaccine effectiveness. PRISMA* flow chart for the systematic review to evaluate rotavirus vaccine effectiveness in countries from Latin America and the Caribbean
Fig. 5
Fig. 5
Effectiveness of RotaTeq TM and Rotarix TM vaccines in preventing rotavirus-related hospital admissions or rotavirus gastroenteritis. Effectiveness of RotaTeq TM and Rotarix TM vaccines in preventing rotavirus-related hospital admissions or rotavirus gastroenteritis according to (a) partial or full vaccination scheme, (b) age at immunization, and (c) severity of the disease. a Neighborhood controls, b Rotavirus negative control participants

References

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