Vigilancia pasiva de la seguridad postautorización de las vacunas frente a rotavirus: sensibilidad de la notificación de invaginación intestinal / Post-licensure passive safety surveillance of rotavirus vaccines: Reporting sensitivity for intussusception

INTRODUCCIÓN: Los objetivos de este estudio fueron describir las notificaciones de sospechas de reacciones adversas relacionadas con las vacunas frente a rotavirus y valorar la sensibilidad de la notificación para invaginación intestinal. MATERIAL Y MÉTODOS: Estudio descriptivo, a partir de las notificaciones de sospechas de reacciones adversas relacionadas con las vacunas frente a rotavirus, ocurridas en niños menores de diez meses, registradas en el Centro de Farmacovigilancia de la Comunidad Valenciana durante el periodo 2007-2011.Se comparó la tasa de notificación de invaginaciones con la tasa de invaginaciones en vacunados obtenida utilizando la base de datos de altas hospitalarias (CMBD) y el registro nominal de vacunaciones autonómico. RESULTADOS: La tasa de notificación de eventos adversos fue de 20 por 100.000 dosis administradas. El 74% de las notificaciones se clasificaron como no graves, siendo la fiebre, los vómitos y la diarrea las sospechas más frecuentes. Dos casos de invaginación, ocurridos en los siete primeros días tras la vacunación, fueron notificados como asociados temporalmente a la vacunación. La sensibilidad de la notificación de invaginación intestinal para el periodo de riesgo de uno a siete días fue del 50%. CONCLUSIONES: Los resultados sugieren que las vacunas frente a rotavirus presentan un perfil de seguridad en general adecuado, y que el Centro de Farmacovigilancia de la Comunidad Valenciana, comparado con otros sistemas de vigilancia pasiva, es igualmente sensible para detectar señales de posible asociación con invaginación intestinal. Este riesgo requiere ser investigado con estudios epidemiológicos bien diseñados y comparado con los evidentes beneficios que estas vacunas proporcionan

INTRODUCTION: The aims of this study were to describe the reports of suspected adverse events due to rotavirus vaccines, and assess the reporting sensitivity for intussusception. MATERIAL AND METHODS: Descriptive 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. RESULTS: The 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 diarrhea 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%. CONCLUSIONS: Our 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

[Post-licensure passive safety surveillance of rotavirus vaccines: reporting sensitivity for intussusception]. / Vigilancia pasiva de la seguridad postautorización de las vacunas frente a rotavirus: sensibilidad de la notificación de invaginación intestinal.

INTRODUCTION: The aims of this study were to describe the reports of suspected adverse events due to rotavirus vaccines, and assess the reporting sensitivity for intussusception. MATERIAL AND METHODS: Descriptive 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. RESULTS: The 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 diarrhea 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%. CONCLUSIONS: Our 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.