Session Title: VACCINE AND PREVENTION
ROTAVIRUS VACCINES IN CHILDREN, EVALUATION OF SAFETY, EFFICACY AND EFFICIENCY
J. Ruiz-Aragon1, S. Marquez-Pelaez1, A.I. Ruiz Aragon2, A. Torrecilla3, F. Garcia4
1Agencia Evaluacion Tecnologias Sanitarias de Andalucia, Consejeria de Salud, Junta de Andalucia, 2Universidad de Sevilla, Sevilla, 3Distrito Condado Campiño, Servicio Andaluz de Salud, Huelva, 4Secretaria General Salud Publica y Participacion, Consejeria de Salud, Junta de Andalucia, Sevilla, Spain
Background and aims: Rotavirus is the main agent which causes gastrointestinal disease in infants. It could provokes severe diarrhoea, often requires hospitalization and sometimes causes death, majority in developing countries. Prevention of the infection could be considered an important objective in Public Health, and vaccination could contribute to this proposal. This study assess safety, efficacy and efficiency of rotavirus vaccines.
Methods: Systematic review of rotavirus vaccines (Rotashield®, Rotarix®, RotaTeq®). Data Source: MedLine, Embase, Center for Reviews and Dissemination Database, Cochrane Library, EMEA, FDA, ClinicalTrials.gov register, CEA Registry and Euronheed. We included studies with healthy children. Interventions was vaccination versus no vaccination. The quality was evaluated by means of the criteria of the CASP checklist and Jadad scale.
Results: Ten clinical trials, a systematic review, and 14 economic studies were included. Majority of the studies showed no significant differences between groups about adverse effects or cases of intususception. Vaccine efficacy was superior to 50%. The value range for QALY gained was 21,900-155,077€ and for DALY gained was 34.25-164,386 €.
Conclusions: Rotavirus vaccines are safe, with typical adverse reactions. The efficacy is high, they could prevent acute gastroenteritis and reduce the number of hospitalizations and medical visits. The variability in the economics results, together with the vaccine cost, meant the cost-effectiveness was substantially influenced by the assumptions of the models and that vaccination could be expensive for the health system.