Seguridad de las vacunas antigripales en grupos de riesgo: análisis de las sospechas de reacciones adversas notificadas en Comunidad Valenciana entre 2005 y 2011 / Safety of influenza vaccines in risk groups: analysis of adverse events following immunization reported in Valencian Community from 2005 to 2011

Objetivo. Evaluar las notificaciones de sospechas de reacciones adversas a las vacunas administradas frente a la gripe, por sexo, grupos de riesgo y por grupos de edad en la Comunidad Valenciana desde el año 2005 a 2011. Métodos. Se ha realizado un estudio farmacoepidemiológico de diseño observacional descriptivo y transversal, basado en las notificaciones de sospechas de reacciones adversas a las vacunas (NRAV) frente a la gripe, registradas a través del Sistema de Información Vacunal (SIV) de la Comunidad Valenciana, de 1 de enero de 2005 hasta 31 de diciembre de 2011. Resultados. Durante el periodo de estudio se registraron 5.107.790 dosis de vacuna frente a la gripe, con una tasa de notificación de NRAV de 1,94 por 100.000 (IC95% 1,59-2,36) y 228.094 dosis de vacuna de gripe A(H1N1)pdm09 (tasa 96,45 por 100.000; IC95% 84,52-110,06). El 70,71% (70) y el 64,55% (142), respectivamente, de las NRAV correspondieron a mujeres. El grupo de riesgo de trabajadores sociosanitarios presentó una mayor tasa de notificación para la gripe estacional (25,35 por 100.000; IC95%: 17,65-36,40) así como para gripe A(H1N1)pdm09 (864,13 por 100.000; IC95% 714,38-1044,93) durante el periodo de estudio. Conclusiones. Las vacunas frente a la gripe administradas durante el periodo de estudio muestran un elevado perfil de seguridad tanto en población con patología de riesgo como en otros grupos diana susceptibles de la vacunación. Las reacciones registradas durante el estudio coinciden en su mayoría con las descritas en las fichas técnicas de las vacunas (AU)

Objective. To evaluate reports of adverse events following influenza immunization by sex, risk and age groups in Valencian Community from 2005 to 2011. Methods. A pharmacoepidemiological descriptive cross-sectional observational study based on the reports of adverse events following immunization (AEFI) against influenza, registered through the Vaccination Information System (SIV) of Valencian Community from 1 January 2005 until 31 December 2011 was done. Results. During the study period 5,107,790 doses of vaccine against influenza were reported, with an AEFI incidence of 1.94 per 100,000 (95% CI 1.59 to 2.36), and 228,094 doses of vaccine for influenza A (H1N1) pdm09 (96.45 per 100,000, 95%CI 84.52-110.06). The 70.71% (70) and 64.55% (142), respectively, of AEFI were in women. The healthcare workers group had a higher reporting rate for seasonal influenza (25.35 per 100,000; 95%CI: 17.65-36.40) and for influenza A(H1N1) pdm09 (864.13 per 100,000; 95%CI 714.38-1044.93) during the study period. Conclusions. Vaccines against influenza administered during the study had a high safety profile in both populations with disease risk and other susceptible target groups of vaccination. Adverse reactions reported during the study mostly coincide with those described in the summary of product characteristics of vaccines (AU)

[Safety of influenza vaccines in risk groups: analysis of adverse events following immunization reported in Valencian Community from 2005 to 2011]. / Seguridad de las vacunas antigripales en grupos de riesgo: análisis de las sospechas de reacciones adversas notificadas en Comunidad Valenciana entre 2005 y 2011.

OBJECTIVE: To evaluate reports of adverse events following influenza immunization by sex, risk and age groups in Valencian Community from 2005 to 2011. METHODS: A pharmacoepidemiological descriptive cross-sectional observational study based on the reports of adverse events following immunization (AEFI) against influenza, registered through the Vaccination Information System (SIV) of Valencian Community from 1 January 2005 until 31 December 2011 was done. RESULTS: During the study period 5,107,790 doses of vaccine against influenza were reported, with an AEFI incidence of 1.94 per 100,000 (95% CI 1.59 to 2.36), and 228,094 doses of vaccine for influenza A (H1N1) pdm09 (96.45 per 100,000, 95%CI 84.52-110.06). The 70.71% (70) and 64.55% (142), respectively, of AEFI were in women. The healthcare workers group had a higher reporting rate for seasonal influenza (25.35 per 100,000; 95%CI: 17.65-36.40) and for influenza A(H1N1) pdm09 (864.13 per 100,000; 95%CI 714.38-1044.93) during the study period. CONCLUSIONS: Vaccines against influenza administered during the study had a high safety profile in both populations with disease risk and other susceptible target groups of vaccination. Adverse reactions reported during the study mostly coincide with those described in the summary of product characteristics of vaccines.