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Efficacy, safety and effectiveness of licensed rotavirus vaccines: a systematic review and meta-analysis for Latin America and the Caribbean.
BMC Pediatr 2017; 17(1):14BPed

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.

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.

Authors+Show Affiliations

Unidad de Investigación Médica en Enfermedades Infecciosas, Hospital de Pediatría, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.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.Centro de Excelencia Capacitación, Investigación y Gestión para la Salud basada en Evidencias CIGES, Universidad de La Frontera, Temuco, Chile.Centro de Excelencia Capacitación, Investigación y Gestión para la Salud basada en Evidencias CIGES, Universidad de La Frontera, Temuco, Chile.Centro de Excelencia Capacitación, Investigación y Gestión para la Salud basada en Evidencias CIGES, Universidad de La Frontera, Temuco, Chile.GSK Vaccines, Panamá City, Panamá.GSK Vaccines, Panamá City, Panamá.

Pub Type(s)

Journal Article
Meta-Analysis
Review
Systematic Review

Language

eng

PubMed ID

28086819

Citation

Velázquez, Raúl F., et al. "Efficacy, Safety and Effectiveness of Licensed Rotavirus Vaccines: a Systematic Review and Meta-analysis for Latin America and the Caribbean." BMC Pediatrics, vol. 17, no. 1, 2017, p. 14.
Velázquez RF, Linhares AC, Muñoz S, et al. Efficacy, safety and effectiveness of licensed rotavirus vaccines: a systematic review and meta-analysis for Latin America and the Caribbean. BMC Pediatr. 2017;17(1):14.
Velázquez, R. F., Linhares, A. C., Muñoz, S., Seron, P., Lorca, P., DeAntonio, R., & Ortega-Barria, E. (2017). Efficacy, safety and effectiveness of licensed rotavirus vaccines: a systematic review and meta-analysis for Latin America and the Caribbean. BMC Pediatrics, 17(1), p. 14. doi:10.1186/s12887-016-0771-y.
Velázquez RF, et al. Efficacy, Safety and Effectiveness of Licensed Rotavirus Vaccines: a Systematic Review and Meta-analysis for Latin America and the Caribbean. BMC Pediatr. 2017 01 13;17(1):14. PubMed PMID: 28086819.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy, safety and effectiveness of licensed rotavirus vaccines: a systematic review and meta-analysis for Latin America and the Caribbean. AU - Velázquez,Raúl F, AU - Linhares,Alexandre C, AU - Muñoz,Sergio, AU - Seron,Pamela, AU - Lorca,Pedro, AU - DeAntonio,Rodrigo, AU - Ortega-Barria,Eduardo, Y1 - 2017/01/13/ PY - 2015/12/11/received PY - 2016/12/30/accepted PY - 2017/1/15/entrez PY - 2017/1/15/pubmed PY - 2018/2/24/medline KW - Diarrhea KW - Effectiveness KW - Efficacy KW - Gastroenteritis KW - Hospitalization KW - RV1 KW - RV5 KW - Rotavirus KW - Safety KW - Vaccination SP - 14 EP - 14 JF - BMC pediatrics JO - BMC Pediatr VL - 17 IS - 1 N2 - 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. 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. SN - 1471-2431 UR - https://www.unboundmedicine.com/medline/citation/28086819/Efficacy_safety_and_effectiveness_of_licensed_rotavirus_vaccines:_a_systematic_review_and_meta_analysis_for_Latin_America_and_the_Caribbean_ L2 - https://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-016-0771-y DB - PRIME DP - Unbound Medicine ER -