Background: Rotavirus (RV) vaccine, Rotarix, was introduced into the Brazil national immunization program in 2006. To estimate population-level vaccine effect, we conducted a time–trend analysis on all-cause gastroenteritis (GE)-related death certificate–reported deaths (DCRDs), hospital deaths (HDs) and hospitalizations trends in <5-year-olds before and after RV vaccine introduction.
Methods: National level all-cause GE-related death certificate [Mortality Information System] and admission (Hospital Information System) data were aggregated and analyzed. Negative-binomial regression models (adjusting for age, year and region) compared DCRDs, HDs and hospitalization trends in <5-year-olds between baseline (2001−2005) and postvaccine introduction periods (Mortality Information System: 2007−2009 and Hospital Information System: 2007−2010). Negative-binomial regression models were fitted to data for each outcome before 2006, and the predicted annual frequencies of each outcome were plotted against corresponding observed annual frequencies.
Results: During the postvaccine introduction period, there was an overall age-independent GE-related DCRDs reduction (20.9%, P = 0.04) observed in children <5 years of age; a reduction was also seen in infants <1 year of age (20.8%, P = 0.003). Age-independent GE-related HDs and hospitalizations reductions (57.1%, P < 0.0001 and 26.6%, P < 0.0001, respectively) were observed in <5-year-olds; HDs reductions were also observed for each age group (<1-year-olds: 55.0%, P < 0.0001 and 1- to <5-year-olds: 59.5%, P < 0.0001). Observed annual frequencies of GE-related DCRDs, HDs and hospitalizations were lower than the predicted value in each age group in all years after 2006.
Conclusions: GE-related DCRDs, HDs and hospitalizations were significantly reduced in <1 and in 1- to <5-year-old Brazilian children after Rotarix introduction, which provides additional evidence of the direct and indirect population-level effect of RV vaccination on GE-related mortality and morbidity in children.
From the *Secretaria de Saúde do Estado do Pará, Belém, Brazil; *Department of Epidemiology, Secretaria de Saúde do Estado do Pará, Belém, Brazil; †Virology Section, Instituto Evandro Chagas, Secretaria de Vigilância em Saúde, Ministry of Health, Belém, Brazil; ‡GSK Vaccines, Rio de Janeiro, Brazil; §Epidemiology and Health Outcomes, GSK Vaccines, Regional Office, Panamá, Brazil; ¶Research & Development, GSK Pharmaceuticals, Bangalore, India; ‖VxR&D Medical, GSK Vaccines, Regional Office, Panamá, Brazil; and **VxR&D Medical & Clinical Latin America, GSK Vaccines, Rio de Janeiro, Brazil.
Accepted for publication December 21, 2015.
GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the study conduct and analyses. GlaxoSmithKline Biologicals SA also paid all costs associated with the development and the publication of this article. The authors have the following conflicts to declare, K. Gopala, E. Ortega-Barria, R. Colindres are employees of GSK and D. Fermín Argüello and S. Tuboi are former employees of GSK. M. C. A. Justino and A. C. Linhares disclose receiving grants from GSK, I. Costa and M. H. Cunha report receiving fees from GSK during the conduct of the study.
Address for correspondence: Alexandre Linhares, MD, PhD, Evandro Chagas, BR 316, Km 7, Levilândia, Ananindeua, Pará CEP 67.030-000, Brazil. E-mail: email@example.com.