TY - JOUR T1 - Post-licensure passive safety surveillance of rotavirus vaccines: Reporting sensitivity for intussusception JO - Anales de Pediatría (English Edition) T2 - AU - Pérez-Vilar,S. AU - Díez-Domingo,J. AU - Gomar-Fayos,J. AU - Pastor-Villalba,E. AU - Sastre-Cantón,M. AU - Puig-Barberà,J. SN - 23412879 M3 - 10.1016/j.anpede.2013.10.006 DO - 10.1016/j.anpede.2013.10.006 UR - https://www.analesdepediatria.org/en-post-licensure-passive-safety-surveillance-rotavirus-articulo-S2341287914000349 AB - IntroductionThe aims of this study were to describe the reports of suspected adverse events due to rotavirus vaccines, and assess the reporting sensitivity for intussusception. Materials and methodsDescriptive study performed using the reports of suspected adverse events following rotavirus vaccination in infants aged less than 10 months, as registered in the Pharmacovigilance Centre of the Valencian Community during 2007–2011.The reporting rate for intussusception was compared to the intussusception rate in vaccinated infants obtained using the hospital discharge database (CMBD) and the regional vaccine registry. ResultsThe adverse event reporting rate was 20 per 100,000 administered doses, with the majority (74%) of the reports being classified as non-serious. Fever, vomiting, and diarrhoea were the adverse events reported more frequently. Two intussusception cases, which occurred within the first seven days post-vaccination, were reported as temporarily associated to vaccination. The reporting sensitivity for intussusception at the Pharmacovigilance Centre in the 1–7 day interval following rotavirus vaccination was 50%. ConclusionsOur results suggest that rotavirus vaccines have, in general, a good safety profile. Intussusception reporting to the Pharmacovigilance Centre shows sensitivity similar to other passive surveillance systems. The intussusception risk should be further investigated using well-designed epidemiological studies, and evaluated in comparison with the well-known benefits provided by these vaccines. ER -