Influence of epidemiological and clinical factors in the reactogenicity to Comirnaty® vaccine in health care workers of a Spanish university teaching hospital (COVIVAC study) / Influencia de factores epidemiológicos y clínicos en la reactogenicidad a la vacuna Comirnaty® en trabajadores sanitarios de un hospital universitario español (estudio COVIVAC)

Introduction. Comirnaty® is an mRNA vaccine against COVID-19 which has been administered to millions of people since the end of 2020. Our aim was to study epidemiological and clinical factors influencing reactogenicity and functional limitation after the first two doses of the vaccine in health care workers (HCWs). Material and methods. Prospective post-authorization cohort study to monitor safety and effectiveness of the vaccine. Results. Local side effects were mild and presented both with first and second dose of Comirnaty. Systemic side effects were more frequent after 2nd dose. Nevertheless, previous SARS-CoV-2 infection was associated with systemic effects after the first dose of the vaccine (OR ranging from 2 to 6). No severe adverse effects were reported. According to multivariate analysis, the degree of self-reported functional limitation after the first dose increased with age, female sex, previous COVID-19 contact, previous SARS-CoV-2 infection, and Charlson Comorbidity Index (CCI). After the second dose, the degree of functional limitation observed was lower in those with previous SARS-CoV-2 infection, and it was positively associated to the degree of functional limitation after the first dose. Conclusion. Systemic adverse effects were more frequent after the second dose of Comirnaty. Previous SARS-CoV-2 infection was associated with systemic effects after the first dose. Age, female sex, previous COVID-19, previous isolation due to COVID-19 contact, and CCI showed to be independent predictors of the degree of functional limitation after the 1st dose of Comirnaty®. After the 2nd dose, the degree of functional limitation was lower in those who previously had SARS-CoV-2 infection (AU)

Introducción. Comirnaty® es una vacuna de ARNm contra el COVID-19 que se ha administrado a millones de personas desde finales de 2020. Nuestro objetivo fue estudiar los factores epidemiológicos y clínicos que influyen en la reactogenicidad y la limitación funcional asociadas tras las dos primeras dosis de la vacuna en trabajadores de la salud. Metodología. Estudio de cohorte prospectivo post-autorización para evaluar la seguridad y eficacia de la vacuna. Resultados. Los efectos secundarios locales fueron leves y se presentaron tanto con la primera como con la segunda dosis de Comirnaty. Los efectos secundarios sistémicos fueron más frecuentes después de la segunda dosis. No obstante, la infección previa por SARS-CoV-2 se asoció con efectos sistémicos tras la primera dosis de la vacuna (OR de 2 a 6). No se informaron efectos adversos graves. El análisis multivariante demostró que el grado de limitación funcional tras la primera dosis aumentó con la edad, el sexo femenino, contacto previo con COVID-19, la infección previa por SARS CoV-2 y el índice de comorbilidad de Charlson (ICC). Tras la segunda dosis, el grado de limitación funcional observado fue menor en aquellos con infección previa por SARS-CoV-2, y se asoció positivamente al grado de limitación funcional tras la primera dosis.Conclusión. Los efectos adversos sistémicos fueron más frecuentes después de la segunda dosis de Comirnaty. La infección previa por SARS-CoV-2 se asoció con efectos sistémicos después de la primera dosis. La edad, el sexo femenino, infección por COVID-19 previa, el aislamiento previo por contacto de COVID-19 y el ICC se mostraron como predictores independientes del grado de limitación funcional tras la 1ª dosis de Comirnaty®. Después de la 2.ª dosis, el grado de limitación funcional fue menor en los que previamente tenían infección por SARS-CoV-2 (AU)

[Analysis of the efficiency of hospitals in Castilla y León (Spain)]. / Análisis de la eficiencia de los hospitales de Castilla y León.

OBJECTIVE: The analysis of efficiency represents an area of growing interest in the field of public management. Hospital efficiency depends mainly on the use that the institution makes of its resources and their cost. The importance of hospital efficiency studies is justified by the fact that health spending is the second most important item of public spending. The objective of the present study focused on the analysis of the degree of efficiency with which the public hospitals of Castilla y León were managed. METHODS: The scope of the research was limited to the 14 hospitals of the Public Health Service of Castilla y León (Sacyl), taking the five-year period 2014-2018 as the study period. For the analysis, the non-parametric technique of Data Envelopment Analysis (DEA) was used. Both constant returns to scale (CRS) and variable returns to scale (VRS) have been used, calculating the global technical efficiency, pure technical efficiency and scale efficiency for each health institution. RESULTS: The grouped results showed that the global technical efficiency (GTE) had reached an average of 92.02%, the pure technical efficiency (PTE) 94.10% and the scale efficiency (EE) 97.74%. CONCLUSIONS: The DEA is presented as a valid technique for analyzing the efficiency of hospitals, with the efficiency of all groups of hospitals (groups I, III and IV) being very similar in terms of PTE, around 97%, with the exception of group II hospitals that are the least efficient.

OBJETIVO: El análisis de la eficiencia representa un área de creciente interés en el ámbito de la gestión pública, siendo además el gasto sanitario la segunda partida más importante del gasto público. La eficiencia hospitalaria depende principalmente del uso que la institución haga de sus recursos y del coste de los mismos. El objetivo del presente trabajo se centró en el análisis del grado de eficiencia con el que se gestionaban los hospitales públicos de Castilla y León. METODOS: El ámbito de la investigación se circunscribió a los catorce hospitales del Servicio Público de Salud de Castilla y León (Sacyl) durante el quinquenio 2014-2018. Se empleó la técnica no paramétrica del Análisis Envolvente de Datos (DEA), utilizándose tanto rendimientos constantes a escala (CRS) como rendimientos variables a escala (VRS), calculando la eficiencia técnica global, la eficiencia técnica pura y la eficiencia de escala para cada institución sanitaria. RESULTADOS: Los resultados agrupados mostraron que la eficiencia técnica global (ETG) alcanzó un promedio de un 92,02%, la eficiencia técnica pura (ETP) un 94,10% y la eficiencia de escala (EE) un 97,74%. CONCLUSIONES: El DEA se presenta como una técnica válida para el análisis de la eficiencia de los hospitales siendo, en términos de ETP, muy semejante la eficiencia de todos los grupos de hospitales (grupos I, III y IV), en torno al 97%, a excepción de los hospitales del grupo II que resultan los menos eficientes.

Análisis de la eficiencia delos hospitales de Castilla y León / Analysis of the efficiency of hospitals in Castilla y León (Spain)

FUNDAMENTOS: El análisis de la eficiencia representa un área de creciente interés en el ámbito de la gestión pública, siendoademás el gasto sanitario la segunda partida más importante del gasto público. La eficiencia hospitalaria depende principalmentedel uso que la institución haga de sus recursos y del coste de los mismos. El objetivo del presente trabajo se centró en el análisis delgrado de eficiencia con el que se gestionaban los hospitales públicos de Castilla y León. MÉTODOS: El ámbito de la investigación se circunscribió a los catorce hospitales del Servicio Público de Salud de Castilla y León (Sacyl) durante el quinquenio 2014-2018. Se empleó la técnica no paramétrica del Análisis Envolvente de Datos (DEA), utilizándose tanto rendimientos constantes a escala (CRS) como rendimientos variables a escala (VRS), calculando la eficiencia técnica global, la eficiencia técnica pura y la eficiencia de escala para cada institución sanitaria. RESULTADOS: Los resultados agrupados mostraron que la eficiencia técnica global (ETG) alcanzó un promedio de un 92,02%, la eficiencia técnica pura (ETP) un 94,10% y la eficiencia de escala (EE) un 97,74%. CONCLUSIONES: El DEA se presenta como una técnica válida para el análisis de la eficiencia de los hospitales siendo, en términos de ETP, muy semejante la eficiencia de todos los grupos de hospitales (grupos I, III y IV), en torno al 97%, a excepción de los hospitales del grupo II que resultan los menos eficientes.(AU)

BACKGROUND: The analysis of efficiency represents an area of growing interest in the field of public management. Hospital efficiency depends mainly on the use that the institution makes of its resources and their cost. The importance of hospital efficiency studies is justified by the fact that health spending is the second most important item of public spending. The objective of the present study focused on the analysis of the degree of efficiency with which the public hospitals of Castilla y León were managed. METHODS: The scope of the research was limited to the 14 hospitals of the Public Health Service of Castilla y León (Sacyl), taking the five-year period 2014-2018 as the study period. For the analysis, the non-parametric technique of Data Envelopment Analysis (DEA) was used. Both constant returns to scale (CRS) and variable returns to scale (VRS) have been used, calculating the global technical efficiency,pure technical efficiency and scale efficiency for each health institution. RESULTS: The grouped results showed that the global technical efficiency (GTE) had reached an average of 92.02%, the pure technical efficiency (PTE) 94.10% and the scale efficiency (EE) 97.74%. CONCLUSIONS: The DEA is presented as a valid technique for analyzing the efficiency of hospitals, with the efficiency of all groups of hospitals (groups I, III and IV) being very similar in terms of PTE, around 97%, with the exception of group II hospitals that are the least efficient.(AU)

Impacto de la vacunación antigripal sobre la enfermedad cardiovascular / The impact of influenza vaccination on cardiovascular disease

La gripe se ha identificado como un factor desencadenante o agravante de los eventos cardiovasculares. Con el objetivo analizar el efecto de la vacunación antigripal en la enfermedad cardiovascular se realizó una búsqueda sistemática de estudios publicados entre 2009 y 2019. Se consideraron todos los trabajos que evaluaron el efecto de la vacunación frente a la gripe sobre eventos cardiovasculares y su evolución. Finalmente se incluyeron 30 de los 1.147 estudios identificados. Estos trabajos ponen de manifiesto el efecto protector de la vacuna antigripal tanto en el desarrollo de eventos cardiovasculares (infarto de miocardio, ictus, fibrilación auricular e insuficiencia cardíaca) como en el empeoramiento de estos procesos. Además, se demuestra que los pacientes vacunados presentan un menor riesgo de muerte por enfermedades cardiovasculares. La vacunación antigripal es, pues, una medida efectiva en la prevención de enfermedades cardiovasculares tanto en personas con enfermedad cardiovascular establecida como en aquellas sin patología previa. (AU)

Influenza infection has been identified as a triggering or exacerbating factor for cardiovascular events. To analyse the effect of influenza vaccination on cardiovascular disease, a systematic search of studies published between 2009-2019 was conducted. All the studies that evaluated the effect of vaccination against influenza on cardiovascular events and their outcome were considered. Finally, 30 of the 1147 identified studies were included. These studies show a protective effect of the influenza vaccine on the development of cardiovascular events (myocardial infarction, cerebrovascular accidents, atrial fibrillation, and heart failure) and on the worsening of these conditions. Furthermore, the data showed that vaccinated patients have a lower risk of death from cardiovascular pathologies. Influenza vaccination is therefore an effective measure in the prevention of cardiovascular diseases both in patients with established cardiovascular disease and in the population without previous coronary pathology. (AU)

The impact of influenza vaccination on cardiovascular disease. / Impacto de la vacunación antigripal sobre la enfermedad cardiovascular.

Influenza infection has been identified as a triggering or exacerbating factor for cardiovascular events. To analyse the effect of influenza vaccination on cardiovascular disease, a systematic search of studies published between 2009-2019 was conducted. All the studies that evaluated the effect of vaccination against influenza on cardiovascular events and their outcome were considered. Finally, 30 of the 1147 identified studies were included. These studies show a protective effect of the influenza vaccine on the development of cardiovascular events (myocardial infarction, cerebrovascular accidents, atrial fibrillation, and heart failure) and on the worsening of these conditions. Furthermore, the data showed that vaccinated patients have a lower risk of death from cardiovascular pathologies. Influenza vaccination is therefore an effective measure in the prevention of cardiovascular diseases both in patients with established cardiovascular disease and in the population without previous coronary pathology.

Vacunación antigripal como medida más efectiva para hacer frente al impacto clínico y económico de la gripe / Flu vaccination as the most effective measure to face the clinical and economic impact of the complaint

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Vacunación frente al neumococo en adultos mayores de 65 años / Pneumococcal vaccine for adults over 65

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The impact of candidate influenza virus and egg-based manufacture on vaccine effectiveness: Literature review and expert consensus.

INTRODUCTION: Influenza is associated with significant morbidity and mortality worldwide. Whilst vaccination is key for the prevention of influenza infection, there are many factors which may contribute to reduced vaccine effectiveness, including antigenic evolution via both antigenic drift and egg-adaptations. Due to the currently dissociated and indirect evidence supporting both the occurrence of these two phenomena in the egg-based manufacturing process and their effects on vaccine effectiveness, this topic remains a subject of debate. OBJECTIVE: To review the evidence and level of agreement in expert opinion supporting a mechanistic basis for reduced vaccine effectiveness due to egg-based manufacturing, using an expert consensus-based methodology and literature reviews. METHODS: Ten European influenza specialists were recruited to the expert panel. The overall research question was deconstructed into four component principles, which were examined in series using a novel, online, two-stage assessment of proportional group awareness and consensus. The first stage independently generated a list of supporting references for each component principle via literature searches and expert assessments. In the second stage, a summary of each reference was circulated amongst the experts, who rated their agreement that each reference supported the component principle on a 5-point Likert scale. Finally, the panel were asked if they agreed that, as a whole, the evidence supported a mechanistic basis for reduced vaccine effectiveness due to egg-based manufacturing. RESULTS: All component principles were reported to have a majority of strong or very strong supporting evidence (70-90%). CONCLUSIONS: On reviewing the evidence for all component principles, experts unanimously agreed that there is a mechanistic basis for reduced vaccine effectiveness resulting from candidate influenza virus variation due to egg-based manufacturing, particularly in the influenza A/H3N2 strain. Experts pointed to surveillance, candidate vaccine virus selection and manufacturing stages involving eggs as the most likely to impact vaccine effectiveness.

Quadrivalent cell culture influenza virus vaccine. Comparison to egg-derived vaccine.

Influenza virus infections pose a serious public health problem and vaccination is the most effective public health intervention against them. The current manufacture of influenza vaccines in embryonated chicken eggs entails significant limitations. These limitations have been overcome by producing vaccines in cell culture, which allow a faster and more flexible response to potential pandemic threats. Given the impact of influenza B virus on disease burden, the availability of quadrivalent vaccines is useful for increasing the rate of protection from disease. This paper analyzes the limitations of the current production of influenza vaccine in eggs and the advantages of vaccines developed in cell culture, as well as their safety, tolerability, efficacy and effectiveness. Additionally, we reflect on the contribution of new quadrivalent vaccines from cell culture as an alternative in seasonal vaccination campaigns against influenza.

Evaluación económica de la vacunación frente al neumococo en mayores de 65 años de Castilla y León / Economic evaluation of pneumococcal vaccination in adults aged over 65 years in Castilla y León (SPAIN)

Introducción: La carga de enfermedad por neumonía en adultos mayores supone un impacto de gran magnitud en los sistemas de salud. El objetivo de este trabajo es realizar una evaluación económica de la estrategia de vacunación frente a Streptococcus pneumoniae mediante la vacuna neumocócica conjugada 13-valente frente a la no vacunación. Material y métodos: Se ha desarrollado un modelo económico simulado en forma de árbol de decisión para evaluar el coste/efectividad de la estrategia de vacunación en la cohorte de población mayor de 65 años del Área de Salud de Valladolid-Este versus no vacunación mediante un análisis probabilístico de Monte Carlo. Resultados: Streptococcus pneumoniae origina anualmente en el Área de Salud Valladolid-Este un total de 557,24 casos de enfermedad neumocócica, de los cuales 506,60 episodios son cuadros neumónicos. A partir del tercer año, la vacunación a la población mayor de 65 años es una medida eficiente, con un coste por años de vida ajustados por calidad (AVAC) de 20.496,20 Euros. El número de AVAC ganados en una década es de 86,07 y se evitaría el gasto de 216.252,89 Euros con esta estrategia vacunal. Conclusiones: La evaluación de los diferentes costes incrementales (AVAC y euros) en los años de seguimiento pone de manifiesto que el programa de vacunación frente al neumococo a personas mayores de 65 años en Castilla y León es una medida coste eficiente

Introduction: The burden of disease due to pneumonia in older adults has a major impact on health systems. The aim of this study is to carry out an economic evaluation of the vaccination strategy against Streptococcus pneumoniae using the 13-valent pneumococcal conjugate vaccine. Material and methods: A simulated economic model has been developed in the form of a decision tree to evaluate the cost of the vaccination strategy in the population over 65 years of the Valladolid-East Health Area, versus non-vaccination, using a Monte Carlo probabilistic analysis. Results: Streptococcus pneumoniae annually generates 557.24 cases of pneumococcal disease in the Valladolid-East Health Area, and 506.60 episodes have pneumonia symptoms. Vaccination of the cohort over 65 years of age is an efficient measure from the third year, with a cost per quality-adjusted life years (QALY) of 20,496.20 Euros. The number of QALYs gained in a decade is 86.07 and an amount of 216.252.89 Euros with this vaccination strategy would be saved. Conclusions: The evaluation of the different incremental costs (QALY,euros) in the years of follow-up, the pneumococcus vaccination program in people over 65 in Castilla y León is cost-effective

[Economic evaluation of pneumococcal vaccination in adults aged over 65 years in Castilla y León (SPAIN)]. / Evaluación económica de la vacunación frente al neumococo en mayores de 65 años de Castilla y León.

INTRODUCTION: The burden of disease due to pneumonia in older adults has a major impact on health systems. The aim of this study is to carry out an economic evaluation of the vaccination strategy against Streptococcus pneumoniae using the 13-valent pneumococcal conjugate vaccine. MATERIAL AND METHODS: A simulated economic model has been developed in the form of a decision tree to evaluate the cost of the vaccination strategy in the population over 65 years of the Valladolid-East Health Area, versus non-vaccination, using a Monte Carlo probabilistic analysis. RESULTS: Streptococcus pneumoniae annually generates 557.24 cases of pneumococcal disease in the Valladolid-East Health Area, and 506.60 episodes have pneumonia symptoms. Vaccination of the cohort over 65 years of age is an efficient measure from the third year, with a cost per quality-adjusted life years (QALY) of 20,496.20 €. The number of QALYs gained in a decade is 86.07 and an amount of 216.252.89 € with this vaccination strategy would be saved. CONCLUSIONS: The evaluation of the different incremental costs (QALY,euros) in the years of follow-up, the pneumococcus vaccination program in people over 65 in Castilla y León is cost-effective.

Recogida de datos y control microbiológico para la intervención global de la tuberculosis / Data Collection And Microbiological Monitoring In Global Tuberculosis Intervention

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Gripe estacional en España: carga clínica y económica y programas de vacunación / Seasonal influenza in Spain: Clinical and economic burden and vaccination programmes

Con el objetivo de analizar la carga clínica, el impacto económico de la gripe y la eficiencia de los programas de vacunación antigripal en España, se ha llevado a cabo una revisión de la literatura. La incidencia media de gripe en España se sitúa en 2.069 casos por 100.000 habitantes, con un impacto relevante en mortalidad y la disminución de la calidad de vida relacionada con la salud. En cuanto a los costes asociados, la gripe genera todos los años una importante carga en atención primaria, hospitalaria, tratamientos y absentismo laboral, que podrían suponer hasta 1.000 millones de euros anuales. La vacunación es una medida eficiente para su prevención y puede generar ahorros para el sistema de salud. En conclusión, la gripe es un problema de salud relevante que anualmente genera una carga económica y clínica importante, pero cuya caracterización y medición deben ser mejoradas

A literature review has been carried out to analyse the clinical burden, the economic impact of influenza and the efficiency of influenza vaccination programmes in Spain. The average incidence rate of influenza in Spain is 2,069 cases per 100,000 inhabitants, with a significant impact on mortality and a reduction of health-related quality of life. In terms of its associated costs, influenza causes a significant burden on primary care, hospitals, treatments and absences from work every year, which could total one billion euros per year. Vaccination is an efficient measure for its prevention and can generate savings for the healthcare system. In conclusion, influenza is a significant health problem which generates a major economic and clinical burden annually; the profiling and measurement of which must be improved

La vacuna tetravalente de cultivo celular: hacia la mejora de la eficacia de la vacuna de la gripe / Quadrivalent cell culture influenza virus vaccine. Towards improving the efficacy of the influenza vaccine

No disponible

Seasonal influenza in Spain: Clinical and economic burden and vaccination programmes. / Gripe estacional en España: carga clínica y económica y programas de vacunación.

A literature review has been carried out to analyse the clinical burden, the economic impact of influenza and the efficiency of influenza vaccination programmes in Spain. The average incidence rate of influenza in Spain is 2,069 cases per 100,000 inhabitants, with a significant impact on mortality and a reduction of health-related quality of life. In terms of its associated costs, influenza causes a significant burden on primary care, hospitals, treatments and absences from work every year, which could total one billion euros per year. Vaccination is an efficient measure for its prevention and can generate savings for the healthcare system. In conclusion, influenza is a significant health problem which generates a major economic and clinical burden annually; the profiling and measurement of which must be improved.

Cell culture-derived flu vaccine: Present and future.

The benefit of influenza vaccines is difficult to estimate due to the complexity of accurately assessing the burden of influenza. To improve the efficacy of influenza vaccines, vaccine manufacturers have developed quadrivalent influenza vaccine (QIV) formulations for seasonal vaccination by including both influenza B lineages. Three parallel approaches for producing influenza vaccines are attracting the interest of many vaccine manufacturing companies. The first and oldest is the conventional egg-derived influenza vaccine, which is used by the current licensed influenza vaccines. The second approach is a cell culture-derived influenza vaccine, and the third and most recent is synthetic vaccines. Here, we analyze the difficulties with vaccines production in eggs and compare this to cell culture-derived influenza vaccines and discuss the future of cell culture-derived QIVs.