Abstract
BackgroundAlthough rotavirus vaccines have been licensed in Spain for over 8 years, they are not funded by its public health systems. The analysis of their effectiveness in the Valencia Region could better inform decisions about potential inclusion in the official immunization schedule. Our aim was to assess the effectiveness of Rotarix® (RV1) and RotaTeq® (RV5) against rotavirus hospitalizations.MethodsWe conducted a retrospective cohort study using the region’s health care databases, among resident children aged <3 years covered by the National Health System, during January 2007-June 2012. We compared two cohorts of vaccinated children: the first included children who received at least one dose of a rotavirus vaccine, and the second included children who were not vaccinated with rotavirus vaccines but received at least one dose of a pneumococcal vaccine, another licensed but non-funded vaccine. The main outcome was rotavirus hospitalization, either laboratory-confirmed (confirmed) or codified as rotavirus (probable). Rotavirus vaccine effectiveness (RVE) by vaccine brand was assessed using Cox proportional hazards models.ResultsThe study included 78,281 rotavirus and 96,643 pneumococcal vaccinees. Adjusted RVE against probable or confirmed rotavirus hospitalizations was 86% (95% CI: 78-91%) and 88% (95% CI: 81-92%) for a complete series of RV1 and RV5 respectively.ConclusionsBoth rotavirus vaccines were over 85% effective against rotavirus hospitalization among young children. The high effectiveness shown argues in favor of their inclusion in the official schedule. Additional information on rotavirus vaccine safety, duration of protection, and benefit-risk will also be needed to inform such deliberations.
Highlights
Rotavirus vaccines have been licensed in Spain for over 8 years, they are not funded by its public health systems
The cohort of children vaccinated with any rotavirus vaccine, and the comparison cohort were similar with respect to gender, residence status, and performance of a rotavirus detection test during gastroenteritis hospitalization
Children included in the rotavirus cohort were more likely to be vaccinated in private centers (14.4% vs. 10.9%; p < 0.001) and slightly more likely to be covered by the universal health system (95.3% vs. 93.7%; p < 0.001) than children included in the non-rotavirus cohort
Summary
Rotavirus vaccines have been licensed in Spain for over 8 years, they are not funded by its public health systems. The analysis of their effectiveness in the Valencia Region could better inform decisions about potential inclusion in the official immunization schedule. Rotavirus is the leading cause of severe pediatric gastroenteritis: 39% (29%-45%) of hospitalized diarrhea cases worldwide during 2000–2004 were attributable to rotavirus [1]. In the Valencia Region, rotavirus is responsible for 53% of all gastroenteritis hospitalizations among children aged
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