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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Notificación de reacciones adversas a la vacuna frente al virus del papiloma humano en la Comunidad Valenciana (2007-2011) / Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007-2011)

INTRODUCCIÓN: En 2009, 2 casos de convulsiones en adolescentes tras la administración de la vacuna tetravalente frente al virus del papiloma humano (VPH) generaron impacto mediático y afectaron negativamente la confianza del público en esta vacuna. Nuestros objetivos fueron describir las sospechas de reacciones adversas (SRA) notificadas al Centro Autonómico de Farmacovigilancia de la Comunidad Valenciana (CAFCV) tras la administración de la vacuna frente al VPH y comparar la tasa de notificación de síncope y convulsiones de esta vacuna con la de otras vacunas administradas en adolescentes. MATERIAL Y MÉTODOS: Estudio descriptivo de las notificaciones de SRA relacionadas con esta vacuna recibidas por el CAFCV entre 2007 y 2011. RESULTADOS: Las manifestaciones clínicas más comunicadas fueron mareos, cefalea y síncope. Las tasas de notificación de síncope o pérdida de conciencia y convulsiones con la vacuna frente al VPH fueron de 17 y 3,2 por 100.000 dosis administradas, respectivamente, y de 15 y 1,6 para síncope o pérdida de conciencia y convulsiones sincopales ocurridas el día de la vacunación. Las tasas de notificación de síncope o pérdida de conciencia y convulsiones fueron de 6,4 y 0,4 para otras vacunas. CONCLUSIONES: Las tasas de notificación de síncope o pérdida de conciencia y convulsiones fueron mayores para la vacuna frente al VPH que para otras vacunas administradas en adolescentes; esto es consistente con la atención mediática originada por la vacuna y con hallazgos de estudios previos. No obstante, la información obtenida sobre las SRA a la vacuna sugiere un buen perfil de seguridad

INTRODUCTION: In 2009, two cases of seizures in adolescents following quadrivalent human papillomavirus vaccine (qHPV) administration, generated important media attention, and adversely affected public trust in this vaccine. Our objectives were to describe suspected adverse reactions (SARs) reported to the Pharmacovigilance Centre in the Valencian Community (PCVC) after administration of HPV vaccine, and to compare reporting rates of syncope and seizures following this vaccine with those of other vaccines administered to girls aged 13-15 years. MATERIAL AND METHODS: Descriptive study of SARs reported following this vaccine to the PCVC between 2007 and 2011. RESULTS: The clinical symptoms most frequently reported were dizziness, headache, and syncope. Reporting rates of syncope or loss of consciousness and seizures with qHPV vaccine were 17 and 3.2 per 100,000 doses administered, respectively, and 15 and 1.6 for syncope or loss of consciousness and syncopal seizures occurred on the day of vaccination. The reporting rates of syncope or loss of consciousness and seizures were 6.4 and 0.4, for the other vaccines. CONCLUSIONS: Consistent with the media attention generated, and with results from other studies, the reporting rates of syncope or loss of consciousness and seizures were higher for the HPV vaccine than for other vaccines given in adolescence. Nevertheless, the overall information obtained on SARs following the qHPV vaccine suggests a good safety profile

Intradermal and virosomal influenza vaccines for preventing influenza hospitalization in the elderly during the 2011-2012 influenza season: a comparative effectiveness study using the Valencia health care information system.

BACKGROUND: The use of intradermal vaccination or virosomal vaccines could increase protection against influenza among the vulnerable population of older adults. Studies assessing the comparative effectiveness of these two influenza vaccine types in this age group are lacking. METHODS: We conducted a retrospective cohort study to estimate the comparative effectiveness of intradermal seasonal trivalent-influenza vaccine (TIV) delivered by a microneedle injection system and a virosomal-TIV intramuscularly delivered for prevention of influenza hospitalization in non-institutionalized adults aged ≥65 years. We obtained administrative data on immunization status and influenza hospitalization for the 2011-2012 influenza season, and used Cox regression models to assess comparative effectiveness. We estimated crude and adjusted (age, sex, comorbidity, pharmaceutical claims, recent pneumococcal vaccination and number of hospitalizations for all causes other than influenza between the previous and current influenza seasons) hazard ratios (HR). RESULTS: Overall, 164,021 vaccinated subjects were evaluated. There were 127 hospitalizations for influenza among 62,058 subjects, contributing 914,740 person-weeks at risk in the virosomal-TIV group, and 133 hospitalizations for influenza among 101,963 subjects, contributing 1,504,570 person-weeks at risk in the intradermal-TIV group. The crude HR of intradermal-TIV relative to virosomal-TIV was 0.64 (95% confidence interval (CI): 0.50-0.81), and the adjusted Cox estimated HR was 0.67 (95% CI: 0.52-0.85). CONCLUSIONS: During the 2011-2012 influenza season the risk of hospitalization for influenza was reduced by 33% in non-institutionalized elderly adults who were vaccinated with intradermal-TIV compared with virosomal-TIV.

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

[Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007-2011)]. / Notificación de reacciones adversas a la vacuna frente al virus del papiloma humano en la Comunidad Valenciana (2007-2011).

INTRODUCTION: In 2009, two cases of seizures in adolescents following quadrivalent human papillomavirus vaccine (qHPV) administration, generated important media attention, and adversely affected public trust in this vaccine. Our objectives were to describe suspected adverse reactions (SARs) reported to the Pharmacovigilance Centre in the Valencian Community (PCVC) after administration of HPV vaccine, and to compare reporting rates of syncope and seizures following this vaccine with those of other vaccines administered to girls aged 13-15 years. MATERIAL AND METHODS: Descriptive study of SARs reported following this vaccine to the PCVC between 2007 and 2011. RESULTS: The clinical symptoms most frequently reported were dizziness, headache, and syncope. Reporting rates of syncope or loss of consciousness and seizures with qHPV vaccine were 17 and 3.2 per 100,000 doses administered, respectively, and 15 and 1.6 for syncope or loss of consciousness and syncopal seizures occurred on the day of vaccination. The reporting rates of syncope or loss of consciousness and seizures were 6.4 and 0.4, for the other vaccines. CONCLUSIONS: Consistent with the media attention generated, and with results from other studies, the reporting rates of syncope or loss of consciousness and seizures were higher for the HPV vaccine than for other vaccines given in adolescence. Nevertheless, the overall information obtained on SARs following the qHPV vaccine suggests a good safety profile.

[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.

MF59-adjuvanted and virosomal influenza vaccines for preventing influenza hospitalization in older people: comparative effectiveness using the Valencia health care information system.

BACKGROUND: Adjuvanted influenza vaccines offer greater and broader immunogenicity to older adults than conventional vaccines. Studies assessing the comparative effectiveness of adjuvanted influenza vaccines in this age group are lacking. METHODS: We conducted a retrospective cohort study to estimate the comparative effectiveness of MF59-adjuvanted trivalent influenza vaccine (TIV) and virosomal-TIV for prevention of influenza hospitalization in adults aged ≥65 years. We obtained administrative data on immunization status and influenza hospitalization for the 2010-2011 influenza season. We used Cox regression models to assess comparative effectiveness; crude and adjusted by age, sex, comorbidity, deprivation, type of insurance, and travel time to hospital. We accounted for data clustering at the hospital level by using a multilevel random effects model. RESULTS: Overall, 373,798 vaccinated subjects were evaluated. There were 40 hospitalizations for influenza among 176,618 subjects, contributing 4,288,109 person-weeks at risk in the virosomal-TIV group, and 37 hospitalizations for influenza among 197,180 subjects, contributing 4,786,360 person-weeks at risk in the MF59-TIV group. The crude hazard ratio (HR) was 0.83 (0.53-1.30), and the adjusted Cox estimated HR of MF59-TIV relative to virosomal-TIV was 0.86 (0.55-1.35). After accounting for data clustering, the HR of influenza hospitalization associated with MF59-TIV relative to virosomal-TIV was 0.94 (0.37-2.38). CONCLUSION: During the 2010-2011 influenza season, we found no differences in the risk of influenza hospitalization in subjects aged ≥65 years vaccinated with MF59-TIV compared with those vaccinated with virosomal-TIV.

[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