Rapid assessment of enhanced safety surveillance for influenza vaccine.

OBJECTIVES: The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The aim of the study is to demonstrate the effectiveness of the vaccine information system of the Valencia region to make a rapid assessment of the influenza vaccine safety and describe the safety of the two vaccine types used in the 2017/2018 season. STUDY DESIGN: It is a population-based descriptive study. METHODS: Adverse events following immunization reports collected from 23rd October 2017 to 15th March 2018 were analyzed. RESULTS: A total of 55 adverse events for influenza vaccine were reported in season 2017/2018 with a reporting rate (RR) of 0.77 per 10,000 administered doses. Injection site reactions had a RR of 0.30 and 0.47 per 10,000 for subunit and adjuvanted vaccines, respectively. Differences per vaccine, sex, and risk group did not reach statistical significance. CONCLUSIONS: Reported events of the two influenza vaccine types used were similar than in other seasons and consistent with their safety profiles.

Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system.

OBJECTIVES: The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting. STUDY DESIGN: A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out. METHODS: Analysis of vaccinations and reported AEFI via SIV in Valencian Community was carried out. RESULTS: More than 13 million vaccines doses were administered during 2005 through 2011, the reporting rate of adverse events was 12.4/100,000 doses administered with the highest value in 2009 (27.4), with differences by age and sex. DTaP vaccine had the highest reporting in children (96.6/100,000) while influenza A(H1N1)pdm09 in adults (87.7/100,000). An increased reporting of adverse events was seen with DTaP in children 5-6 years of age, detected in real time, drove to swap this vaccine to a low dose Tdap which was followed by a decrease in administration site events. CONCLUSIONS: SIV demonstrates advantages for passive surveillance. Reporting rates by individual characteristics are calculated accurately and it also allows detecting shifts in reporting rate on real time for specific vaccines. The study shows that vaccines included in the routine vaccination schedule for children and adult vaccination programs are safe.

Vacunación antigripal en grupos de riesgo. Temporada 2013-14 en la Comunidad Valenciana / Influenza vaccination in risk groups. 2013-2014 season in the Community of Valencia

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[Development of the incidence of pneumonia in the autonomous community of Valencia throughout the 1995-2001 period. A retrospective study]. / Evolución de la incidencia de neumonías en la Comunidad Valenciana desde 1995 a 2001. Estudio retrospectivo.

AIM: To know development pneumonias throughout 1995 to 2001. METHODS: The data source was obtained from the database of the Minimum Basic Data Set. We selected three pneumonia hospitalized causes in the Community of Valencia, Bronchopneumonia, and Pneumonia for not specified organism and invasive pneumococcal disease. It was realized the statistical analysis by SPSS programme. Calculating the pneumonia incidence rate and its time development and observing the interactions between age group, genre, mean of age, stay in the hospital and origin. RESULTS: The incidence for the period was 209 per 100,000 people, that increased significantly until it stabilized in 1999. The pneumonia affected more frequently men than women and specially aged 65 years or more. For age the pneumonias are more frequent in subjects younger than 5 and older than 65, (maximum 76-77 years old). It was observed statistically significant differences between provinces. The stays on hospital was greater for men and this ground with age groups, this is longer in people 65 years old or older. The average stay depending on the aged groups but do not exist statistically differences between genre and age group. CONCLUSIONS: Pneumonia is a pathology originated from different causes, it affect principally men and more especially at younger than 5 years and older than 65 years. The incidences stabilizing on the studied period last years. This works must be continued for clarify if it is the same way for the development by the different pneumonias types on this time period and if exists the interactions between the different variables.

Evolución de la incidencia de neumonías en la Comunidad Valenciana desde 1995 a 2001. Estudio retrospectivo / Development of the incidence of pneumonias in the autonomous community of Valencia throughout the 1995-2001. A retrospective study

Fundamento: Conocer la evolución de las neumonías desde 1995 a 2001. Método: Los datos se obtuvieron del Conjunto Mínimo Básico de Datos, seleccionando tres causas de hospitalización por neumonías en la Comunidad Valenciana, bronconeumonía, neumonía por organismo no especificado y neumonía neumocócica. El análisis estadístico se realizó mediante el programa SPSS, hallando las incidencias de las neumonías y su evolución en el tiempo y observando interacciones entre las variables género, edad, estancia y procedencia. Resultados: La incidencia fue de 209 por 100.000 habitantes, aumentando significativamente a lo largo del periodo hasta estabilizarse a partir de 1999. La neumonía afecta más a hombres que a mujeres, sobre todo en mayores de 65 años. Por edades, son más frecuentes en menores de 5 años y en mayores de 65, concentrándose el mayor número de casos en 76-77 años. Se han observado diferencias estadísticamente significativas en las incidencias por provincias. El número de estancias es mayor en hombres que en mujeres y aumentan por grupos de edad, siendo más elevadas en los mayores de 65 años. La estancia media, varía según la edad, sin existir diferencias significativas entre género o grupo de edad. Conclusiones: La neumonía, patología originada por diferentes causas, afecta más a hombres que a mujeres, a menores de 5 años y a mayores de 65. Las incidencias se estabilizan en los últimos años de estudio. Se deberían seguir estas investigaciones para dilucidar si las diferentes neumonías en este periodo, evolucionan igualmente y si se dan interacciones entre las variables estudiadas

Aim: To know development pneumonias throughout 1995 to 2001. Methods: The data source was obtained from the database of the Minumum Basic Data Set. We selected three pneumonia hospitalized causes in the Community of Valencia, Broncopneumonia, and Pneumonia for not specified organism and invasive pneumococcal disease. It was realized the statistical analysis by SPSS programme. Calculating the pneumonia incidence rate and its time development and observing the interactions between age group, genre, mean of age, stay in the hospital and origin. Results: The incidence for the period was 209 per 100.000 people, that increased significantly until it stabilized in 1999. The pneumonia affected more frequently men than women and specially aged 65 years or more. For age the pneumonias are more frequent in subjects younger than 5 and older than 65, (maximum 76-77 years old). It was observed statistically significant differences between provinces. The stays on hospital was greater for men and this ground with age groups, this is longer in people 65 years old or older. The average stay depending on the aged groups but do not exist statistically differences between genre and age group. Conclusions: Pneumonia is a pathology originated from different causes, it affect principally men and more especially at younger than 5 years and older than 65 years. The incidences stabilizing on the studied period last years. This works must be continued for clarify if it is the same way for the development by the different pneumonias types on this time period and if exists the interactions between the different variables