ABSTRACT
INTRODUCCIÓN La enfermedad neumocócica (EN) es una infección bacteriana causada por Streptococcus pneumoniae, que afecta principalmente a la población pediátrica, adultos mayores de 65 años y personas con factores de riesgo. La prevención se basa en la vacunación, ya sea con vacunas conjugadas (VCN) o vacunas polisacáridas (VNP). En España se recomienda actualmente la VCN13 para niños y la VNP23 para mayores de 60 o 65 años; a los grupos de riesgo se les administra VNP23 sola o en combinación con VCN13. Las nuevas VCN frente a 15 y 20 serotipos - VCN15 y VCN20 - recientemente autorizadas por la Comisión Europea, han sido desarrolladas para abordar el aumento de casos de EN por serotipos no cubiertos por las vacunas actuales. Han demostrado su no inferioridad en inmunogenicidad respecto a VCN13, pero aún no se dispone de datos de eficacia protectora. Para la posible sustitución de la vacunación actual por las nuevas VCN se precisa de resultados de su coste-efectividad. OBJETIVOS Evaluar el coste-efectividad, describir las consi
INTRODUCTION Pneumococcal disease is a bacterial infection caused by Streptococcus Pneumoniae, which mainly affects children, older adults above 65 years old and people with underlying conditions. Prevention consists of vaccination, with either conjugate vaccines (PCV) or polysaccharide vaccines (PPSV). In Spain, PCV13 is recommended for children and PPSV23 for adults older than 60 or 65 years, while populations with underlying conditions are vaccinated with PPSV23 alone or in combination with PCV13. New PCVs against 15 and 20 serotypes - PCV15 and PCV20 - recently authorized by the European Commission, have been developed in order to address the increase of cases of Pneumococcal disease caused by serotypes not covered by current vaccine options. These new options have proven their non-inferiority regarding immunogenicity of PCV13, but data on their protective efficiency is not available. In order to explore the possibility of substituting current vaccination options for the new PCV options, results on their cost-effectiveness are needed. OBJECTIVES Evaluate cost-effectiveness, describe ethical, legal, organizational, social and environmental considerations, and identify research needs regarding universal vaccination against pneumococcal disease with the new PCV against 15 and 20 serotypes. METHOD Systematic review of economic evaluations A systematic review was conducted in order to identify scientific evidence regarding cost-effectiveness of universal vaccination against Pneumococcal Disease with PCV15 or PCV20 in the paediatric population, population over 65 years old or population with underlying conditions. Studies published until 31/8/2023 were eligible. Methodological quality was valued following the criteria proposed by Drummond et al. Cost-effectiveness analysis A complete economic evaluation was carried out, in which costs and health outcomes for universal vaccination against pneumococcal disease were evaluated for three populations: children younger than 5 years old, immunocompetent population older than 65 years of age and immunocompromised population older than 18 years of age. This analysis was based on a decision model which synthesizes Spain's epidemiologic data (2022 incidence), vaccine efficiency and costs, as well as consequences and/or side effects of the diseases of interest (in terms of costs and quality-adjusted life years (QALY) gained). Three Markov models with annual cycles were developed. A 3% discount rate was applied to both costs and effects. For each vaccination strategy considered the incremental cost-effectiveness ratio (ICER) was calculated and it was compared with the cost-effectiveness threshold of 25 000/QALY. In addition, probabilistic and deterministic sensitivity analyses were carried out. Budget impact analysis A budget impact analysis for a period of 5 years was conducted in order to inform about the cost that the implantation of the new vaccination strategies would have for the Spanish National Health System. RESULTS Systematic review of economic evaluations After conducting a systematic search in four electronic databases, 16 economic evaluations that evaluated at least one of the new PCV were identified. ⢠Children: Six studies evaluated paediatric vaccination, only one of them without conflict of interest. Results were homogeneous, finding the new PCVs cost-effective or dominant compared to PCV13 for different European countries, USA and Japan. In the economic evaluation identified for Spain and funded by PCV15 manufacturer, it is concluded that this new vaccine is cost-effective compared to PCV13, with an ICER of 3582 per QALY. ⢠Elderly: Ten economic evaluations were identified in Europe, USA and Japan, only two of them without conflict of interest. Nine studies concluded that the new PCV is dominant or cost-effective compared to the current strategy of the country. Four studies compared the new PCVs with one another, including one study in Spain, and results allowed the conclusion in favour of the PCV20, regardless of the funding. ⢠Population with underlying conditions: Evaluated in five studies conducted in Europe, all of them being funded by one of the manufacturers. All the studies conclude in favour of the new PCV evaluated, when compared to the current strategy of each country. Comparison between PCV15 and PCV20 benefits PCV20, regardless of the funding. Cost-effectiveness analysis ⢠Paediatric population: New PCVs would avoid more cases of illness caused by Streptococcus Pneumoniae than the current strategy (PCV13). The strategy of replacing PCV13 for the PCV15 would be dominant (more effective and less costly), while its substitution for the PCV20 would not be cost-effective (ICER 169,335 per QALY). Results are sensitive to vaccine coverage (if it decreases, ICER increases) and to vaccine price (PCV20 would be cost-effective if its price would drop by 22%, from 47.2 to 36.6). Lowering PCV13's price, new PCVs become not cost-effective. ⢠Immunocompetent population over 65 years: New vaccines are also more beneficial than the current strategy (PPSV23). Strategies that include PCV20 (combined with PPSV23 or alone) are dominant compared to the current strategy, being the PCV20+PPSV23 dominant when compared to the rest of strategies. PCV15 in sequence with PPSV23 would be cost-effective (ICER 1561 per QALY) and PCV15 alone would not be cost-effective (ICER 36,792 per QALY). These results change if the indirect effects of paediatric vaccination with the new PCVs are taken into consideration (only sequential strategies would be cost-effective), or if the PCV15's price would drop by 13% (from 45 to 39). ⢠Immunocompromised adult population: The two most effective strategies are the new PCVs in combination with PPSV23, being both of them dominant against current strategy (PCV13+PPSV23). The sequential strategy involving PCV20+PPSV23 is dominant over the rest of evaluated alternatives. Budget impact analysis ⢠Paediatric population: Vaccination with PCV15 instead of with PCV13 would save 4.2 million euros in the following 5 years. As for PCV20, the impact would be of 92.2 million euros in the following 5 years. ⢠Immunocompetent population over 65 years: Substituting PPSV23 with PCV20 would have a net budget impact of 53 million euros in 5 years; the strategy involving PCV20+PPSV23 would have an impact of 91.2 million euros in 5 years. Both strategies with PCV15 would have an impact of 56.8 and 93.1 million euros in the following 5 years, respectively. ⢠Immunocompromised adult population: Strategies involving PCV20 (alone or with PPSV23) and PCV15 alone would generate savings for the NHS of 207.8 million, 39.3 million and 154.4 million euros, respectively, while the strategy with PCV15+PPSV23 would have an insignificant impact in the following 5 years. CONCLUSIONS Available evidence in scientific literature is limited and comes from studies developed in Europe, USA and Japan, mainly funded by the new PCVs' manufacturers. Most of the published economic evaluations conclude that the vaccination strategies which include new PCVs are cost-effective or dominant: ⢠In the paediatric population new PCVs are cost-effective or dominant (more effective and less costly) compared to PCV13. Specifically, the economic evaluation identified for Spain concludes that PCV15 is cost-effective. ⢠For the population of older adults (≥65 years old), the majority of studies conclude that the new PCV evaluated (PCV15 or PCV20) is dominant or cost-effective against the current strategy of each country. Comparisons between new PCVs with one another, including the Spanish study, conclude in favour of PCV20, regardless of the funding. ⢠For the population with underlying conditions, all the economic evaluations conclude in favour of the new PCVs compared to the current recommendations for each country, and in favour of the PCV20 when compared with PCV15, regardless of the funding. Results of the cost-effectiveness model developed for this report, suggest that in Spain: ⢠In the paediatric population vaccination with PCV15 is a more effective and less costly strategy (dominant) when compared to the current strategy with PCV13. Vaccination with PCV20, apart from requiring an additional dose, is not cost-effective and it only would be if the vaccine price drops by 22%. ⢠In immunocompetent older adults above 65 years old, vaccination with PCV20 alone or in combination with PPSV23 are dominant strategies. PCV15 is only cost-effective if combined with PPSV23. PCV15 alone could be considered cost-effective if its price drops by 13%. ⢠Regarding immunocompromised adult population, PCV15+PPSV23 and PCV20+PPSV23 strategies are dominant and this last one (PCV20+PPSV23) is dominant compared to the rest of alternatives. ⢠Results are sensitive to variations in some parameters such as vaccine price, effectiveness, vaccination coverage or the indirect effects of paediatric vaccination. The net budget impact in 5 years established: ⢠Savings (4.2 million euros) from vaccination with PCV15 in the paediatric population. ⢠Additional costs (53-91.2 million euros) from vaccination with PCV20, administering only PCV20 or in combination with PPSV23 in populations older than 65 years. ⢠Savings (39.3 million euros) with PCV20+PPSV23 vaccination in immunocompromised population. It would be recommendable to update this report in 5 years because of the epidemiologic changes that can occur, the possibility of serotype replacement as a consequence of vaccination and the publication of new data regarding effectiveness of new vacines.
Subject(s)
Vaccination , Immunization Programs , Meningitis, Pneumococcal/prevention & control , Cost-Effectiveness AnalysisABSTRACT
INTRODUCCIÓN La enfermedad meningocócica invasiva (EMI) es una enfermedad infecciosa aguda causada por Neisseria meningitidis o meningococo, y es una de las causas más comunes de meningitis bacteriana en población infantil y adolescente. En España, la EMI afecta fundamentalmente a niños y niñas menores de 5 años, siendo los serogrupos B (60% del total de los casos en menores de 5 años en la temporada 2017-2018), C, W e Y los más frecuentes. La prevención de la EMI y de la meningitis en general se realiza mediante la vacunación. Algunos países europeos como Bélgica, República Checa, Malta y Países Bajos recomiendan la vacunación infantil frente a MenACWY en menores de 24 meses. En nuestro país, la vacunación frente a MenACWY en población infantil no está incluida en el calendario común de vacunación a lo largo de la vida para la población general, pero sí está incluida una dosis en la adolescencia a partir de los 12 años de edad. OBJETIVOS Evaluar el coste-efectividad, las consideraciones éticas, de pacientes, sociales, legales y organizacionales, así como describir las necesidades de investigación de la vacunación sistemática frente a MenACWY en niños y niñas de hasta 12 meses. METODOLOGÍA Coste-efectividad y análisis de impacto presupuestario En primer lugar, se llevó a cabo una revisión sistemática (RS) de la evidencia científica sobre el coste-efectividad de la vacunación frente a MenACWY en población infantil no adolescente. Se incluyeron evaluaciones económicas completas que compararan una estrategia de vacunación sistemática de MenACWY frente a la no vacunación o frente a otra estrategia de vacunación. Se valoró la calidad metodológica mediante los criterios de Drummond et al. Se llevó a cabo una evaluación económica completa en la que se evaluaron los costes y los resultados en salud de la vacunación sistemática de MenACWY en población infantil de hasta 12 meses de edad desde la perspectiva tanto del SNS como social y se comparó con la vacunación frente a MenC en la misma población (situación actual). El análisis se basó en un modelo de decisión que sintetiza la información obtenida en la literatura sobre la incidencia de la enfermedad, la eficacia de la vacuna frente a MenACWY, así como sobre las consecuencias y/o secuelas de la EMI asociada a MenACWY (en términos tanto de costes como de AVAC) que se evitan por la introducción de un programa de vacunación sistemática. Para ello, se realizó un modelo matemático que combina un árbol de decisión y un modelo tipo Markov con ciclos anuales. El horizonte temporal abarca toda la vida del paciente y se aplica una tasa de descuento del 3% tanto a costes como a efectos. Además, se realizaron análisis de sensibilidad probabilísticos y determinísticos. Por último, se realizó un análisis de impacto presupuestario a 5 años (de 2022 a 2026), para informar del coste que supondría la implantación de una estrategia de vacunación sistemática infantil (en población infantil de hasta 12 meses) frente a MenACWY en España (en sustitución de la vacunación frente a MenC). Aspectos organizativos, éticos, sociales y/o legales Se realizó una RS de la literatura, partiendo de la misma población, intervención y comparación mencionadas en el apartado de coste efectividad. La revisión se enfocó en dos de los Criterios de Evaluación para Fundamentar Modificaciones en el Programa de Vacunación en España (2011): la carga de la enfermedad y la modificación del calendario vacunal y sus repercusiones. RESULTADOS Coste-efectividad y análisis de impacto presupuestario La RS sobre coste-efectividad permitió identificar 4 evaluaciones económicas publicadas entre 2005 y 2017 en EEUU, Canadá y Países Bajos. Todos los estudios coinciden en que la vacunación frente a MenACWY reduce el número de casos y de muertes por meningitis. Sólo un estudio compara estrategias de vacunación frente a MenACWY en diferentes grupos poblaciones frente a la no vacunación, concluyendo que la vacunación no es una alternativa coste-efectiva desde la perspectiva social. El resto de los estudios comparan estrategias de vacunación MenACWY frente a MenC en diferentes grupos poblaciones obteniendo, en dos de ellos, que la vacunación frente a MenACWY ahorra costes con respecto a la vacunación frente a MenC, en la infancia. Los resultados del análisis coste-efectividad realizado muestran que el coste promedio por individuo para la estrategia de vacunar frente a MenACWY y vacunar frente a MenC es de 77.92 y 43.76 , respectivamente, desde la perspectiva del SNS. Los AVAC promedio son ligeramente más elevados con la estrategia de vacunar frente a MenACWY. Sin embargo, esta pequeña diferencia en AVAC entre alternativas hace que la vacunación frente a MenACWY no sea una intervención coste-efectiva en comparación con la vacunación frente a MenC (RCEI > 25.000 /AVAC). El análisis de sensibilidad por escenarios muestra que las variaciones en la incidencia de la enfermedad y en el precio de la vacuna tienen un efecto significativo sobre los resultados de coste-efectividad. Cabe destacar que con la incidencia de EMI por cualquier serogrupo actual en nuestro país, si la vacuna frente a MenACWY redujera su precio hasta los 15.20 /dosis, la vacunación frente a MenACWY sería una alternativa coste-efectiva en comparación con la vacunación frente a MenC (RCEI: 23 816.31 /AVAC). El análisis de impacto presupuestario muestra que, dada la baja incidencia actual de la enfermedad y el elevado precio de la vacuna, el coste de los casos de MenACWY evitados por la vacuna, tanto leves como graves, no supera el de la vacunación sistemática a toda la población infantil objeto de vacunación. Por tanto, la implantación de una estrategia de vacunación sistemática frente a MenACWY con dos dosis en sustitución de la vacunación frente a MenC podría suponer un gasto para el SNS de 11 767 217 al quinto año de su introducción en todo el territorio nacional. Esta estimación asume que no se produce un coste extra por la administración de la vacuna infantil dado que se aplicaría dentro de las revisiones de salud pediátricas rutinarias. Aspectos organizativos, éticos, sociales y/o legales Se incluyeron un total de 5 estudios que abordaron estos aspectos. Los estudios incluidos describen las secuelas físicas, neurológicas y psicosociales de la EMI que aumentan la carga sanitaria y socio-familiar asociada a la enfermedad y repercuten negativamente en la calidad de vida a largo plazo de los infectados y sus familias. Los resultados muestran algunos factores estructurales asociados con el incumplimiento del esquema de vacunación frente a MenACWY, están relacionados con determinantes sociales, como el absentismo escolar, la residencia geográfica, la raza/etnicidad, los ingresos familiares y el género. En conjunto, los hallazgos tienen escasa relevancia, debido a que las medidas de resultado utilizadas son dispersas, el período de seguimiento es muy variable y presentan conflictos de interés. Además, presentan diversos diseños metodológicos. No se identificó ningún estudio con metodología cualitativa que pudiera arrojar mayor claridad acerca del fenómeno estudiado. Las investigaciones provienen de países de ingresos altos, pero ninguna realizada en nuestro contexto. CONCLUSIONES ⢠No existe evidencia científica suficiente como para afirmar que la vacunación sistemática infantil frente a MenACWY sea una alternativa coste-efectiva en comparación con la vacunación frente a MenC. ⢠El análisis de coste-efectividad de novo realizado en este informe con datos de España, concluye que la incorporación de una estrategia de vacunación sistemática infantil frente a MenACWY en sustitución de la vacunación frente a MenC, no sería una opción coste-efectiva desde la perspectiva del SNS teniendo en cuenta la incidencia de la enfermedad y el precio de la vacuna actuales. ⢠El análisis de coste-efectividad de novo realizado en este informe con datos de España, concluye que la incorporación de una estrategia de vacunación sistemática infantil frente a MenACWY en sustitución de la vacunación frente a MenC, sería una opción coste-efectiva desde la perspectiva del SNS siempre y cuando el precio de la vacuna frente a MenACWY no supere los 15.20 por dosis. ⢠El análisis de impacto presupuestario estima que la incorporación de una estrategia de vacunación sistemática frente a MenACWY en población de hasta 12 meses podría suponer un gasto de hasta 11 767 217 el quinto año de su introducción en el SNS. ⢠El análisis de los aspectos éticos, organizativos, sociales, de pacientes y ambientales relativos a la vacunación frente a MenACWY en la infancia muestra que los estudios son escasos y sus resultados poco concluyentes, particularmente aquellos estudios referidos a la carga de la enfermedad, la calidad de vida y la modificación del calendario vacunal y sus repercusiones. ⢠Se destaca la ausencia de estudios con metodología cualitativa o mixta que permitan contribuir a la profundización del análisis de la carga de la enfermedad, la calidad de vida a largo plazo y las razones que influyen en el incumplimiento del esquema de vacunación frente a MenACWY que puedan arrojar resultados más sólidos para evaluar estos aspectos en nuestro contexto. ⢠La situación de disparidad observada en el acceso gratuito a la vacunación frente a MenACWY entre las distintas CCAA, pone de manifiesto la inequidad geográfica existente dentro del SNS.
INTRODUCTION Invasive meningococcal disease (IMD) is an acute infectious disease caused by Neisseria meningitidis, or meningococcus, and is one of the most common cause of bacterial meningitis in children and adolescents. In Spain, IMD mainly affects children under five years of age, with serogroups B (60% of all cases in children under five years of age in the 2017-2018 season), and C, W and Y being the most frequent. The prevention of IMD and meningitis in general is through vaccination. Some European countries, such as Belgium, the Czech Republic, Malta and the Netherlands recommend childhood vaccination against MenACWY for children under 24 months of age. In our country, vaccination against MenACWY in children is not included in the national vaccination schedule throughout life for the general population, but it is included in adolescence from 12 years of age. AIMS To assess cost-effectiveness, ethical, patient, social, legal, and organizational considerations, as well as to describe the research needs for routine MenACWY vaccination of children up to twelve months of age. METHODOLOGY Cost-effectiveness and budget impact analysis Firstly, a systematic review (SR) of the scientific evidence on the cost effectiveness of vaccination against MenACWY in children was carried out. Complete economic evaluations comparing a routine vaccination strategy against MenACWY versus no vaccination, or another strategy were included. The methodological quality was assessed using the criteria of Drummond et al. A complete economic evaluation was conducted out in which the costs and health outcomes of routine vaccination against MenACWY in children up to twelve months of age were evaluated versus routine vaccination against MenC from the NHS and societal perspective. The analysis was based on a decision model that synthesizes the information obtained in the literature on the incidence of the disease, the efficacy of the vaccine against MenACWY, as well as the consequences and/or sequelae of IMD associated with MenACWY (in terms of both cost and QALY) that are avoided by the introduction of a routine vaccination programme. In order to do this, a mathematical model was built that combines a decision tree and a Markov type model with annual cycles. The time horizon was patient lifetime and a discount of 3% is applied to both costs and effects. In addition, probabilistic and deterministic sensitivity analyzes by scenarios were carried out. Finally, a five-year budget impact analysis (from 2022 to 2026) was performed to inform about the cost of implementing a systematic childhood vaccination strategy (in children up to 12 months of age) against MenACWY in Spain. Organizational, ethical, social and/or legal issues An SR of the literature was performed, starting from the same population, intervention, and comparison mentioned in the cost-effectiveness section. The review focused on two of the Evaluation Criteria to Support Modifications in the Vaccination Program in Spain (2011): the burden of the disease and the modification of the vaccination schedule and its repercussions. RESULTS Cost-effectiveness and budgetary impact analysis The SR on cost-effectiveness revealed four economic evaluations published between 2005 and 2017 in EEUU, Canada and the Netherlands. All the studies agree that vaccination against MenACWY reduces the number of cases and deaths from meningitis. Only one study compares vaccination strategies against MenACWY in different population groups versus non-vaccination, concluding that vaccination is not a cost-effective alternative from a societal perspective. The rest of the studies compare MenACWY vaccination strategies versus MenC vaccination strategies in different population groups, obtaining in two of them that vaccination against MenACWY is cost-saving with respect to vaccination against MenC in childhood. The results of the cost-effectiveness analysis carried out show that the mean average cost per individual for the strategy of vaccinating against MenACWY and vaccinating against MenC is 77.92 and 43.76, respectively from the NHS perspective. The mean QALYs are slightly higher with the strategy of vaccinating against MenC. However, this small difference in QALYs between alternatives means that vaccinating against MenACWY do not turn out to be cost-effective intervention from the NHS perspective (ICER > 25,000/QALY). These conclusions hold when considering the societal perspective. The sensitivity analysis by scenarios shows that variations in the incidence of the disease and in the price of the vaccine have a significant effect on the cost-effectiveness results. It should be noted that taken into a count the current incidence of IMD by any serogroup in our country, MenACWY vaccination would be a cost-effective alternative compared to vaccination against MenC if the price of MenACWY vaccine was 15.20/dose (ICER: 23,816.31/QALY). The budget impact analysis shows that, given the current low incidence of the disease and the high price of the vaccine, the cost of MenACWY, cases averted by the vaccine, both mild and severe, does not exceed that of routine vaccination throughout Spain for the target child population. Therefore, the implementation of a systematic vaccination strategy against MenACWY with two doses instead of vaccination against MenC could mean an expense for the NHS of 11 767 217 in the fifth year of its introduction across Spain. This estimated expense assumes that there is no extra cost for the administration of the childhood vaccine, since it would be applied as part of routine pediatric health check-ups. Organizational, ethical, social and/or legal issues Five studies that addressed these issues were included. The included studies described the physical, neurological and psychosocial sequelae of IMD that increase the health and socio-familial burden associated with the disease and have a negative impact on the long-term quality of life of those infected and their families. The results showed different structural factors associated with non compliance with the MenACWY vaccination schedule, which are related to social determinants, such as school absenteeism, geographic residence, race/ethnicity, family income and gender. Overall, the findings were of little relevance, since the outcome measures used were disperse, the follow-up period was highly variable, and they presented conflicts of interest. In addition, they had differing methodological designs. No study with qualitative methodology was found that could provide greater clarity about the phenomenon studied and the research came from high-income countries, but none were conducted in the Spanish context. CONCLUSIONS ⢠There is insufficient scientific evidence to ensure that routine childhood vaccination against MenACWY is a cost-effective option compared to vaccination against MenC. ⢠The de novo cost-effectiveness analysis conducted in this report with data from Spain concludes that the incorporation of a systematic childhood vaccination strategy against MenACWY instead of vaccination against MenC would not be a cost-effective option from the perspective of the NHS, taking into account the incidence of the disease and the price of the currently available vaccine. ⢠The de novo cost-effectiveness analysis conducted in this report with data from Spain concludes that the incorporation of a systematic childhood vaccination strategy against MenACWY instead of vaccination against MenC would be a cost-effective option from the perspective of the NHS as long as the price of the vaccine against MenACWY does not exceed 15.20 per dose. ⢠The analysis of the budget impact estimates that the incorporation of a systematic vaccination strategy against MenACWY in the population up to twelve months of age could mean an expense for the NHS of up to 11 767 217 in the fifth year of its introduction. ⢠The analysis of the ethical, organizational, social, patient and environmental aspects related to vaccination against MenACWY in childhood shows that there are few studies and their results are inconclusive, particularly those studies referring to the burden of the disease, quality of life and the modification of the vaccination schedule and its repercussions. ⢠The absence of studies with qualitative or mixed methodology that could contribute a deeper analysis of the burden of the disease, the long-term quality of life and the reasons influencing non-compliance with the vaccination scheme against MenACWY is noteworthy. ⢠The variations observed in the access to vaccination against MenACWY between the different Autonomous Communities, highlights the existing geographical inequity within the NHS.
Subject(s)
Humans , Male , Female , Infant , Vaccination , Immunization Programs , Meningitis, Meningococcal/prevention & control , Cost-Effectiveness AnalysisABSTRACT
INTRODUCCIÓN La gripe estacional es una infección vírica aguda que en los países templados se presenta de forma epidémica con intensidad variable cada temporada. Se caracteriza por el inicio súbito de fiebre, tos (generalmente seca), dolores musculares, articulares, de cabeza y garganta, intenso malestar y abundante secreción nasal. En algunas personas, fundamentalmente aquellas con alto riesgo y ocasionalmente en otras sin riesgo conocido, la gripe puede ser una enfermedad grave que requiere hospitalización, e incluso ser mortal. Se calcula que las epidemias anuales causan 3 a 5 millones de casos graves y 290 000 a 650 000 muertes en el mundo. Algunos países con niveles socioeconómicos similares al nuestro han incorporado la vacunación frente a la gripe al calendario de vacunación infantil. OBJETIVOS Evaluar la efectividad, seguridad, coste-efectividad, las consideraciones éticas, de pacientes, sociales, legales y organizacionales, así como describir las necesidades de investigación de la vacunación frente a la gripe estacional en niñ
INTRODUCTION Seasonal flu is an acute viral infection that occurs as an epidemic in temperate countries with varying degrees of intensity each season. It is characterized by the sudden onset of fever, cough (usually dry), muscle, joint, head and throat pain, intense discomfort and abundant nasal discharge. In some people, especially those at high risk, flu can be a serious illness that requires hospitalization, and can even be fatal. Annual epidemics are estimated to cause three to five million severe cases and 290,000 to 650,000 deaths worldwide. Some countries with socioeconomic levels similar to those in Spain have incorporated influenza vaccination into the child vaccination calendar. AIMS To evaluate the effectiveness, safety, cost-effectiveness, ethical, patient, social, legal and organizational considerations and to describe the research needs of the vaccine against seasonal influenza in children from six to fifty-nine months. METHODOLOGY Effectiveness and safety A pre
Subject(s)
Humans , Male , Female , Infant , Child, Preschool , Vaccination , Influenza, Human/prevention & control , Cost-Effectiveness AnalysisABSTRACT
ANTECEDENTES Y OBJETIVO El 15 de julio de 2017 aparece el primer caso de un brote con características de evento inusitado en un trabajador de una lechería en la provincia de Osorno, región de Los Lagos, Chile. A fines del mes de octubre ya se habían notificado 56 casos y se logra obtener las primeras confirmaciones de serología positiva para fiebre Q. El 2 de noviembre se declara alerta sanitaria por enfermedad zoonótica. En consecuencia, el Ministerio de Salud de Chile solicita este resumen de políticas basado en evidencia, con el objetivo de estudiar estrategias terapéuticas para el control de la fiebre Q, así ayudando a la toma de decisiones. METODOLOGÍA Para identificar la evidencia científica disponible sobre las opciones para abordar el problema se realizó una búsqueda amplia en la base de datos Epistemonikos, mediante una estrategia de búsqueda. RESULTADOS Se trabaja con 1 revisión sistemática Vacunación en Humanos contra Fiebre Q -La vacunación en humanos contra fiebre Q podría disminuir el desarrollo de fiebre Q (certeza de evidencia baja). Vacunación en Animales contra Fiebre Q -El riesgo de diseminación podría disminuir con el uso de vacunación tanto en cabras como en ovejas, versus su no uso. -El riesgo de diseminación probablemente disminuye en leche, fluido vaginal y fecas con el uso de vacunación en animales versus su no uso. Medidas ambientales y medidas de protección para trabajadores -La búsqueda de evidencia no identificó estudios que comparasen el impacto de medidas ergonómicas sobre el desarrollo de fiebre Q. -Esto debiese considerarse como una brecha de evidencia, que pudiera ser abordada por futuras investigaciones Control de hemoderivados -La búsqueda de evidencia no identificó estudios que comparasen el impacto del control de hemoderivados sobre el desarrollo de fiebre Q. -No hay evidencia comparativa entre las diferentes estrategias de control de hemoderivados. Control de plagas -La búsqueda de evidencia encontró una revisión sistemática, la cual evalúa el efecto de un programa en EEUU llevado a cabo entre los años 1997 y 2004. -No está claro si el control de plagas impacta el desarrollo de la enfermedad (certeza de evidencia muy baja).
Subject(s)
Security Measures , Pest Control , Vaccination , Chile , Occupational Health , Coxiella burnetii , Viral Zoonoses , Animal HusbandryABSTRACT
A infecção pelo vírus varicela-zoster (VVZ) se manifesta por meio de dois quadros clínicos distintos: a infecção primária se manifesta como varicela, após a qual o vírus estabelece latência nos gânglios nervosos da raiz dorsal. Muitos anos após a infecção primária, pode ocorrer a reativação do VVZ, que se manifesta como herpes-zoster. Apenas um sorotipo de VVZ é conhecido e humanos são os únicos reservatórios do vírus, sendo possível o controle da infecção em uma população através de imunização ativa, muito embora o estabelecimento de latência viral e a possibilidade de reativação e transmissão do VVZ a partir de um caso de zoster tornem necessárias a manutenção da vigilância e altas coberturas vacinais enquanto existirem indivíduos com infecção latente pelo vírus selvagem. Abordar de forma adequada as formas complexas de manifestação clínica da infecção pelo VVZ na perspectiva populacional tem se constituído em desafio para os estudos de custo-efetividade da vacina contra varicela. A varicela é doença comum da infância e tem distribuição universal. A grande maioria dos casos ocorre em menores de 15 anos de idade e praticamente todos os adultos já foram infectados por VVZ. A doença apresenta distribuição sazonal, com a maioria dos casos ocorrendo no final do inverno e início da primavera (de julho a novembro, no Brasil). Picos epidêmicos têm sido observados a cada três a cinco anos. O tratamento clínico, na maioria dos casos, se resume ao uso de medicação sintomática, anti-térmicos, anti-sépticos e anti-pruriginosos. Nos casos com infecção bacteriana secundária recomenda-se o uso de antibióticos por via oral, observando-se, na prática clínica habitual nos serviços de saúde, uma variabilidade nas drogas prescritas, com reflexos importantes nos custos do tratamento. A vacinação contra a varicela não está contemplada nos calendários básicos de vacinação (criança, adolescente, adulto e idoso) no Brasil, exceto para situações excepcionais, nas quais se disponibiliza a vacina para grupos com riscos específicos. Apesar desta estratégia cumprir importante papel na proteção individual de pessoas mais vulneráveis, o impacto desta ação é inexistente à proteção da coletividade. Em 2013, com o intuito de ampliar esta proteção, o Ministério da Saúde (MS) pretende incluir as vacinas de varicela e hepatite A no calendário básico de vacinação da criança. Para que ocorra a introdução destas novas vacinas é necessário levar em consideração aspectos importantes como a redução dos custos dos imunobiológicos, logística operacional (armazenamento, transporte, seringas e agulhas), eficácia dos insumos além do custo-benefício desses produtos. Portanto, estudos de avaliação econômica em saúde têm apoiado diretamente a tomada de decisão, demonstrando transparência, perspectivas econômicas e epidemiológicas, promovendo assim a eficiência e equidade. Obedecendo a tais prerrogativas. Foram encomendados e apresentados os estudos de custo-efetividade das vacinas de varicela e hepatite A. Faz-se necessário, também, considerar que com as recentes introduções de novas vacinas nos calendários de vacinação do PNI, a rede de frio encontra-se no seu limite da capacidade instalada, em todos os níveis, de modo que há a necessidade de uma avaliação e readequação dessa rede. A vacina de varicela será introduzida no calendário básico de vacinação, para a população de 1 ano de idade, a partir do uso da vacina combinada tetraviral (sarampo, caxumba, rubéola e varicela), substituindo, portanto, o uso da vacina tríplice viral (sarampo, caxumba e rubéola) nesta população. Os membros da CONITEC presentes na 8ª reunião do plenário do dia 06/09/2012, por unanimidade, ratificaram a decisão de recomendar a incorporação da vacina tetraviral na rotina do Programa Nacional de Imunização. A Portaria CTIE-MS N.º 4 de 18 de janeiro de 2013 - Torna pública a decisão de incorporar a vacina tetraviral (varicela, sarampo, caxumba e rubéola) na rotina do Programa Nacional de Imunização do Sistema Único de Saúde (SUS).