Early estimates of nirsevimab immunoprophylaxis effectiveness against hospital admission for respiratory syncytial virus lower respiratory tract infections in infants, Spain, October 2023 to January 2024.

The monoclonal antibody nirsevimab was at least 70% effective in preventing hospitalisations in infants with lower respiratory tract infections (LRTI) positive for respiratory syncytial virus (RSV) in Spain (Oct 2023-Jan 2024), where a universal immunisation programme began late September (coverage range: 79-99%). High protection was confirmed by two methodological designs (screening and test-negative) in a multicentre active surveillance in nine hospitals in three regions. No protection against RSV-negative LRTI-hospitalisations was shown. These interim results could guide public-health decision-making.

Acontecimientos adversos en embarazadas con la vacuna tetravalente contra la gripe obtenida de cultivos celulares / Adverse events in pregnant women with the tetravalent influenza vaccine obtained from cell cultures

La vacunación de la gripe en embarazadas muestra una clara relación beneficio/riesgo. En la actualidad se están desarrollando vacunas contra la gripe utilizando nuevas plataformas. Es imprescindible analizar la seguridad de estas nuevas vacunas en este grupo poblacional, infrarrepresentado en los ensayos clínicos. En la temporada 2019-2020 se aconsejó una vacuna obtenida en cultivo celular a las embarazadas en 2comunidades autónomas. Se recogió información de los centros de vacunación y de farmacovigilancia de ambas comunidades. La tasa de notificación de casos de acontecimientos adversos tras la vacunación en embarazadas fue de 4,02/100.000 dosis administradas y, en mujeres de 18 a 64 años no embarazadas, de 5,9/100.000 dosis administradas. La tasa de acontecimientos adversos notificados fue de 8,04 y 17,74, respectivamente. No se notificaron abortos espontáneos, prematuridad ni malformaciones fetales. Este análisis señala la seguridad en embarazadas de la vacuna de la gripe obtenida de cultivos celulares.(AU)

Influenza vaccination in pregnant women shows a clear benefit/risk ratio. Influenza vaccines are currently being developed using new platforms. It is essential to analyze the safety of these new vaccines in this population group, underrepresented in clinical trials. In the 2019-2020 season, a vaccine obtained in cell culture was recommended to pregnant women in 2autonomous communities. Information is collected from the vaccination and pharmacovigilance centers of both communities. The reporting rate of adverse events after vaccination in pregnant women was 4.02/100,000 doses administered, and in non-pregnant women aged 18-64 years it was 5.9/100,000 doses administered. The rate of adverse events reported was 8.04 and 17.74, respectively. No spontaneous abortions, prematurity or fetal malformations were reported. This analysis suggests the safety in pregnant women of the influenza vaccine obtained from cell cultures.(AU)

Adverse events in pregnant women with the tetravalent influenza vaccine obtained from cell cultures.

Influenza vaccination in pregnant women shows a clear benefit/risk ratio. Influenza vaccines are currently being developed using new platforms. It is essential to analyse the safety of these new vaccines in this population group, underrepresented in clinical trials. In the 2019-2020 season, a vaccine obtained in cell culture was recommended to pregnant women in two autonomous communities. Information is collected from the vaccination and pharmacovigilance centres of both communities. The reporting rate of adverse events (AEs) after vaccination in pregnant women was 4.02/100,000 doses administered, and in non-pregnant women aged 18-64 years it was 5.9/100,000 doses administered. The rate of AE reported was 8.04 and 17.74 respectively. No spontaneous abortions, prematurity or foetal malformations were reported. This analysis suggests the safety in pregnant women of the influenza vaccine obtained from cell cultures.

Trends of Adverse Events Following Immunization (AEFI) Reports of Human Papillomavirus Vaccine in the Valencian Community-Spain (2008-2018).

Vaccine safety surveillance is essential in vaccination programs. We accomplished a descriptive study of surveillance AEFI-reporting rate in human papillomavirus (HPV) vaccine administered in the Valencian Community, Spain. Data were obtained from Spanish Pharmacovigilance Adverse Reactions Data (FEDRA). Reporting rates were calculated using local net doses distributed as the denominator. Trends were assessed using joinpoint regression with annual percent change (APC) reported. The AEFI-reports decreased between 2008 and 2018 in two periods, a fast decreasing rate from 2009 to 2011 (from 192.2 to 24.93 per 100000 doses; APC, -54.9%; 95%CI [-75.2; -17.7]), followed by a stable trend (-13% APC, 95%CI [-26.1; 2.4]). For the age group analysis, only the group aged 14-15 years old followed the same trend with -58.4% (95%CI [-73.9; -33.8]) APC during 2008-2011, and -8.8% (95%CI [-27.7; 15]) APC during 2011-2018. The majority of the reports (73.82%) were nonserious, involving reactions at or near the vaccination site, headache, and dizziness events. No death was reported. AEFI-reporting rates for HPV immunization in the Valencian Community have decreased considerably with two trend periods observed for girls aged 14-15 years old. Currently, the AEFI reporting rate shows a decreasing trend, perhaps following the Weber effect, and it could also be affected by media attention and coverage.

Más no siempre es mejor. Pauta individual o calendario sistemático en vacuna antineumocócica / More is not always better. Individual guideline or systematic vaccination against pneumococcus

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[Activities to catch up and Vaccinate the Susceptible Population in Valencian Community, Spain]. / Actividades para captar y vacunar a la población susceptible en la Comunidad Valenciana.

Eliminating measles and rubella and preventing congenital rubella infection plan of WHO highlighted the need to assess vaccination coverage and develop strategies to improve it and eliminate pockets of low immunization coverage. It exists evidence about the potential role of immunization information systems to improve coverage. The aim of this article is to describe the actions taken from the Vaccine Information System of Valencian Community addressed to improve the vaccination coverage. The Vaccine Information System is a comprehensive information system that allows the management of vaccination programs. It is connected to other systems so that decisions related to vaccinations as clinical and epidemiological management is facilitated. Regarding the role in improving vaccination coverage, the Vaccine Information System facilitates the implementation of all alternatives that have been proven effective: calculate coverage and feedback of results, active recruitment, cooperate with the epidemiological surveillance and logistics management of vaccines. We can conclude, therefore, that the Vaccine Information System is a useful tool to improve vaccination coverage and thus contribute to the elimination of measles and rubella.

Actividades para captar y vacunar a la población susceptible en la Comunidad Valenciana / Activities to catch up and vaccinate the susceptible population in Valencian Community, Spain

La Organización Mundial de la Salud en su revisión del Plan de eliminación del sarampión y la rubéola remarcó la necesidad de evaluar las coberturas vacunales y desarrollar estrategias para mejorarlas y eliminar las bolsas de baja cobertura vacunal. Existe evidencia del papel que pueden jugar los sistemas de información vacunal para mejorar estas coberturas. El objetivo del presente artículo es describir las acciones realizadas a partir del Sistema de Información Vacunal de la Comunidad Valenciana en la mejora de las coberturas vacunales. Se trata de un sistema integral que permite le gestión de los programas de vacunación. Está conectado con otros sistemas de manera que se facilita la toma de decisiones relacionadas con las vacunaciones, tanto clínicas como epidemiológicas o de gestión. Respecto al papel que juega en la mejora de las coberturas vacunales, el Sistema de Información Vacunal facilita la realización de todas las alternativas que se han demostrado efectivas: cálculo de coberturas y difusión de resultados, actividades de captación activa, colaboración con los servicios de vigilancia epidemiológica, gestión de la logística de las vacunas. Se puede concluir, por tanto, que el Sistema de Información Vacunal es una herramienta útil para mejorar las coberturas vacunales y contribuir así a la eliminación del sarampión y la rubéola (AU)

Eliminating measles and rubella and preventing congenital rubella infection plan of WHO highlighted the need to assess vaccination coverage and develop strategies to improve it and eliminate pockets of low immunization coverage. It exists evidence about the potential role of immunization information systems to improve coverage. The aim of this article is to describe the actions taken from the Vaccine Information System of Valencian Community addressed to improve the vaccination coverage. The Vaccine Information System is a comprehensive information system that allows the management of vaccination programs. It is connected to other systems so that decisions related to vaccinations as clinical and epidemiological management is facilitated. Regarding the role in improving vaccination coverage, the Vaccine Information System facilitates the implementation of all alternatives that have been proven effective: calculate coverage and feedback of results, active recruitment, cooperate with the epidemiological surveillance and logistics management of vaccines. We can conclude, therefore, that the Vaccine Information System is a useful tool to improve vaccination coverage and thus contribute to the elimination of measles and rubella (AU)

Noticias sobre el virus del papiloma humano y su vacuna en la prensa valenciana (2006-2011) / News items on human papillomavirus and its vaccine in the Valencian press (2006-2011)

La introducción de la vacuna contra el virus del papiloma humano (VPH) dirigida a mujeres adolescentes ha tenido en España un desarrollo no exento de cierta controversia. Asociada inicialmente al mensaje de "vacuna contra el cáncer de útero" que ofrecía una nueva posibilidad de lucha contra esa enfermedad, obtuvo una réplica que moderaba la euforia con un mensaje dirigido a probar evidencias. Mientras se administraba la segunda dosis de vacuna (febrero de 2009) ocurrió un suceso inesperado en Valencia relacionado con la aparición de acontecimientos adversos tras la administración de la vacuna en dos adolescentes, que tuvo un explosivo tratamiento mediático. Este estudio analiza el alcance y el contenido de las noticias aparecidas en dos periódicos regionales valencianos de gran tirada durante el sexenio 2006-2011 que mencionan al VPH, su vacuna y el cáncer de útero. Se discute la influencia que los mensajes emitidos hayan podido tener en la aceptabilidad de la vacuna (AU)

The process of introducing the human papillomavirus (HPV) vaccine aimed at teenage girls has not been entirely without controversy in Spain. This vaccine was originally hyped as a preventive measure in the fight against cervical cancer but the resulting euphoria was tempered by a message calling for evidence. During administration of the second dose of the vaccine in February 2009, an unexpected turn of events attracted vast media coverage when two teenagers experienced adverse effects after immunization in Valencia (Spain). This study analyzes the scope and content of news items on HPV, immunization and cervical cancer published between 2006 and 2011 in two widely disseminated regional newspapers in Valencia. We also discuss the extent to which the messages transmitted may have influenced acceptability of the vaccine (AU)

[News items on human papillomavirus and its vaccine in the Valencian press (2006-2011)]. / Noticias sobre el virus del papiloma humano y su vacuna en la prensa valenciana (2006-2011).

The process of introducing the human papillomavirus (HPV) vaccine aimed at teenage girls has not been entirely without controversy in Spain. This vaccine was originally hyped as a preventive measure in the fight against cervical cancer but the resulting euphoria was tempered by a message calling for evidence. During administration of the second dose of the vaccine in February 2009, an unexpected turn of events attracted vast media coverage when two teenagers experienced adverse effects after immunization in Valencia (Spain). This study analyzes the scope and content of news items on HPV, immunization and cervical cancer published between 2006 and 2011 in two widely disseminated regional newspapers in Valencia. We also discuss the extent to which the messages transmitted may have influenced acceptability of the vaccine.

[Variability in the reporting of adverse reactions to the pandemic and seasonal influenza vaccine: seasons 2009-2010 and 2010-2011. Valencian community, Spain]. / Variabilidad en la notificación de reacciones adversas a las vacunas de la gripe pandémica y estacional: Temporadas 2009-2010 y 2010-2011, Comunitat Valenciana.

BACKGROUND: The loss of confidence in the safety of vaccines derived from alarm conditions, as in the case of the flu pandemic may affect both vaccination coverage and the sensitivity to the reporting of suspected adverse reactions associated vaccines (SRAAV). The aim of the study is to describe the adverse effects reported to the vaccine against pandemic influenza in the 2009-2010 season and against seasonal influenza in 2009-2010 and 2010-2011 seasons, by type of vaccine, risk groups and by age group in the Valencian Community (CV). METHODS: A retrospective descriptive study has been made of the individuals presenting suspected adverse reactions to the influenza vaccine reported through the Vaccine Information System during the seasons 2009-2010 and 2010-2011 in the Valencian Community. 95% confidence intervals were calculated. RESULTS: During the period 2009-2010 the reporting rate of suspected reactions for seasonal influenza vaccine was 0.020 per thousand doses administered, for the pandemic vaccine 0.95. The reporting rate for seasonal influenza vaccine in the period 2010-2011 was 0.04 per thousand. CONCLUSIONS: There was an increase in the number of reported suspected adverse reactions to the pandemic vaccines compared with the rest of influenza vaccines, during the seasons. The highest suspected adverse reaction reporting rate was for the group of health professionals partner for both vaccines against seasonal and pandemic influenza.

Variabilidad en la notificación de reacciones adversas a las vacunas de la gripe pandémica y estacional. Temporadas 2009-2010 y 2010-2011, Comunitat Valenciana / Variability in the reporting of adverse reactions to the pandemic and seasonal inluenza vaccine. Seasons 2009-2010 and 2010-2011. Valencian Community, Spain

Fundamentos: La pérdida de confianza en la seguridad de las vacunas derivada de situaciones de alarma, como en el caso de la gripe pandémica, puede afectar tanto a las coberturas vacunales como a la sensibilidad frente a la notificación de las sospechas de reacciones adversas asociadas a vacunas (SRAAV). El objetivo del trabajo es describir los efectos adversos a la vacuna frente a la gripe pandémica notificados en la temporada 2009-2010 y comparar si existen diferencias con los descritos con la vacuna de la gripe estacional en las temporadas 2009-2010 y 2010-2011 en la Comunitat Valenciana (CV). Métodos: Se realizó un estudio descriptivo de los individuos vacunados frente a la gripe que presentaron alguna SRAAV a la vacuna antigripal y que fue notificada a través del Sistema de Información Vacunal, durante las temporadas 2009-2010 (incluyendo la vacunación pandémica) y 2010-2011 en CV. se calcularon las tasas de notificación de sospechas de reacciones adversas asociadas a vacunas por cada mil dosis de vacunas administradas y sus intervalos de confianza al 95%. Resultados: Durante el periodo 2009-2010 la tasa de notificación de SRAAV para la vacuna de la gripe estacional fue de 0,02 por mil dosis administradas, para la vacuna pandémica de 0,95. En el periodo 2010-2011 la tasa para la vacuna de la gripe estacional fue de 0,04 por mil. Conclusiones: Durante las temporadas analizadas se incrementó el número de notificaciones de SRAAV para las vacunas pandémicas en comparación con el resto de vacunas antigripales. La mayor tasa de notificación de SRAAV correspondió al grupo de profesionales sociosanitarios, tanto para las vacunas frente a la gripe estacional como pandémica(AU)

Background: The loss of confidence in the safety of vaccines derived from alarm conditions, as in the case of the flu pandemic may affect both vaccination coverage and the sensitivity to the reporting of suspected adverse reactions associated vaccines (SRAAV). The aim of the study is to describe the adverse effects reported to the vaccine against pandemic influenza in the 2009-2010 season and against seasonal influenza in 2009-2010 and 2010-2011 seasons, by type of vaccine, risk groups and by age group in the Valencian Community(CV). Methods: A retrospective descriptive study has been made of the individuals presenting suspected adverse reactions to the influenza vaccine reported through the Vaccine Information System during the seasons 2009-2010 and 2010-2011 in the Valencian Community. 95% confidence intervals were calculated. Results: During the period 2009-2010 the reporting rate of suspected reactions for seasonal influenza vaccine was 0.020 per thousand doses administered, for the pandemic vaccine 0.95. The reporting rate for seasonal influenza vaccine in the period 2010-2011 was 0.04 per thousand. Conclusions: There was an increase in the number of reported suspected adverse reactions to the pandemic vaccines compared with the rest of influenza vaccines, during the seasons. The highest suspected adverse reaction reporting rate was for the group of health professionals partner for both vaccines against seasonal and pandemic influenza(AU)

Pharmacoeconomic assessment of implementing a universal PCV-13 vaccination programme in the Valencian public health system (Spain).

BACKGROUND: Heptavalent pneumococcal conjugate vaccine (PCV-7) was licensed to provide immunity against pneumococcal disease caused by seven serotypes of S. pneumoniae. Thirteen-valent pneumococcal conjugate vaccine (PCV-13) includes 6 additional serotypes for preventing invasive pneumococcal disease. OBJECTIVE: The objective of this study was to estimate the potential health benefits, costs, and cost-effectiveness of vaccination with PCV-13 in the Community of Valencia and to generate valuable information for policy makers at regional and country levels. METHODS: A decision tree was designed to determine the health and economic outcomes in hypothetical cohorts of vaccinated and unvaccinated children followed over their lifetime. Information about disease incidence and serotype distribution were gathered from local databases and from published and unpublished local records. PCV-13 effectiveness was extrapolated from PCV-7 efficacy data. A 5% of herd effect and a serotype replacement of 25% were considered for the base case scenario. Only direct costs were taken into account and results were expressed in terms of life-years gained (LYG) and quality adjusted life years (QALY). RESULTS: Implementing a universal PCV-13 vaccination program in the Community of Valencia would decrease the number of hospital admitted pneumonia to less than 4571 cases while avoiding 310 cases of IPD and 82,596 cases of AOM throughout the cohort lifetime. A total of 190 S. pneumoniae related deaths would be averted over the same period. Total medical costs of non-vaccinating the cohort of newborns would reach up to 403,850.859€ compared to 438,762.712€ that would represent vaccinating the cohort. The incremental cost of vaccinating the children was estimated in 12,794€/LYG and 10,407€/QALY, respectively. CONCLUSIONS: A universal PCV-13 vaccination program in the Community of Valencia would be a cost-effective intervention from the payer perspective after preventing for pneumococcal infections and for decreasing its associated mortality and morbidity.

[Public health service prescriptions of vaccines not included in systematic vaccination programs in Valencian community, Spain, during the period 2004-2009]. / Prescripción de vacunas no incluidas en el calendario vacunal en la Comunitat Valenciana durante el período 2004-2009.

BACKGROUND: In the context of the policies of rational use of medicine, and in order to achieve an efficient management of the vaccinations programs, we expect to know the number of packings and cost of prescribed vaccines not included in the vaccination programs of Valencian Community and its departments during 2009 and to analyze its evolution since 2004, focusing on an analysis of Heptavalent pneumococcal conjugate vaccine in children under two years old. METHODS: Retrospective descriptive study to analyze the prescriptions of vaccines in Valencian Community during 2009 and its evolution since 2004. VARIABLES: vaccine availability, number of packings, group of beneficiary (actives/pensioners), department, and cost of prescriptions. DATA SOURCES: Gestor de Prestación Farmacéutica (GAIA) and Sistema Información Poblacional (SIP). RESULTS: In 2009 prescribed vaccines on official national health system prescription forms that are not included in vaccination programs, supposed a cost of 683.445,71 € corresponding to 17.353 packings (87% of the total prescribed vaccines). Heptavalent pneumococcal conjugate vaccine generated 72% of the total cost of vaccines not included in the vaccination programs. The trend from 2004 to 2009 shows an increase in expenditure of 735.334 € (24,66%) in 2005 from which there takes place a marked and gradual decrease that reaches 1.562.650,67 € (-228.64%). The cost by departments of prescriptions per 1000 children under two years old of pneumococcal conjugate vaccine ranges between 17.377 and 324 €. CONCLUSIONS: The declining trend of prescriptions, mainly of pneumococcal conjugate vaccines, continues during 2009. A great interdepartmental variability is observed, nevertheless, in rates of prescription that should be corrected.

Prescripción de vacunas no incluidas en el calendario vacunal en la Comunitat Valenciana durante el período 2004-2009 / Public health service prescriptions of vaccines not included in systematic vaccination programs in valencian community, Spain, during the period 2004-2009

Fundamentos: En el marco de las políticas de uso racional del medicamento, y al objeto de conseguir una gestión eficiente de los programas de vacunaciones, el objetivo de este trabajo es conocer el número de envases de las vacunas prescritas no incluidas en los programas de vacunación en la Comunitat Valenciana y en sus departamentos de salud, así como el gasto que produjeron en 2009, y analizar la evolución desde 2004, centrando el análisis en la vacuna heptavalente conjugada frente al Streptococcus pneumoniae en menores de dos años. Método: Estudio descriptivo retrospectivo de las vacunas prescritas mediante receta en la Comunitat Valenciana durante el año 2009 y su evolución desde 2004. Variables: número de envases, tipo de beneficiario (activo/pensionista), departamento y gasto generado. Fuentes: Gestor de Prestación Farmacéutica (GAIA) y Sistema Información Poblacional (SIP). Resultados: En 2009 la prescripción mediante receta de vacunas no incluidas en los programas de vacunación generó un gasto de 683.445,71 ] correspondiente a 17.353 envases, lo que supuso el 87! del total del gasto en vacunas recetadas. La vacuna frente al S. pneumoniae generó el 72! del gasto total de las vacunas no incluidas en el calendario. La evolución 2004-2009 muestra un aumento del gasto de 735.334 ] (24,66!) en 2005 a partir del cual se produjo un descenso acusado y paulatino que alcanzó los 1.562.650,67 ] (-228.64!). El gasto por departamentos para la vacuna del neumococo conjugada heptavalente por mil niños/as menores de dos años osciló entre 17.377 y 324 ]. Conclusiones: La tendencia descendente del gasto en recetas prescritas se mantuvo durante 2009, fundamentalmente de vacunas conjugadas frente a neumococo. No obstante, se observó gran variabilidad interdepartamental en las tasas de prescripción que debe ser corregida(AU)

Background: In the context of the policies of rational use of medicine, and in order to achieve an efficient management of the vaccinations programs, we expect to know the number of packings and cost of prescribed vaccines not included in the vaccination programs of Valencian Community and its departments during 2009 and to analyze its evolution since 2004, focusing on an analysis of Heptavalent pneumococcal conjugate vaccine in children under two years old. Methods: Retrospective descriptive study to analyze the prescriptions of vaccines in Valencian Community during 2009 and its evolution since 2004. Variables: vaccine availability, number of packings, group of beneficiary (actives/pensioners), department, and cost of prescriptions. Data sources: Gestor de Prestación Farmacéutica (GAIA) and Sistema Información Poblacional (SIP). Results: In 2009 prescribed vaccines on official national health system prescription forms that are not included in vaccination programs, supposed a cost of 683.445,71 ] corresponding to 17.353 packings (87! of the total prescribed vaccines). Heptavalent pneumococcal conjugate vaccine generated 72! of the total cost of vaccines not included in the vaccination programs. The trend from 2004 to 2009 shows an increase in expenditure of 735.334 ] (24,66!) in 2005 from which there takes place a marked and gradual decrease that reaches 1.562.650,67 ] (-228.64!). The cost by departments of prescriptions per 1000 children under two years old of pneumococcal conjugate vaccine ranges between 17.377 and 324 ]. Conclusions: The declining trend of prescriptions, mainly of pneumococcal conjugate vaccines, continues during 2009. A great interdepartmental variability is observed, nevertheless, in rates of prescription that should be corrected(AU)

Incidence of and risk factors for cat bites: a first step in prevention and treatment of feline aggression.

Feline aggression towards people has a smaller incidence than canine aggression, but also represents an important public health problem. The aim of this work was to analyse feline aggression reported towards people, to estimate its incidence and to assess the risk factors involved. The information was obtained from the Public Health Centres in the Valencian Region (Spain). A total of 936 acts of feline aggression were analysed. Cats inflicted 8% of all animal bites reported. The annual average was 6.36 feline aggression incidents per 100,000 people. Most aggressive incidents occurred during the summer months. Children (0-14 years old) and women were more likely to be bitten. Wounds were mainly punctures, single, and mild, and were located mostly on the hands. In children, the head and neck areas were affected much more than in adults. The cats involved in incidents were mostly Siamese, female and owned; these cats mainly attacked their owners. Most occurrences were a defensive response by the cat.