Estimated Impact of Nirsevimab on the Incidence of Respiratory Syncytial Virus Infections Requiring Hospital Admission in Children < 1 Year, Weeks 40, 2023, to 8, 2024, Spain.

BACKGROUND: Data from the sentinel surveillance system of severe acute respiratory infections in Spain were used to estimate the impact of administration of nirsevimab to children born from 1 April 2023 onwards. METHODS: Estimated RSV hospitalisations in < 1-year-olds during weeks 40, 2023, to 8, 2024, were compared to the number that would be expected after accounting for the background change in RSV circulation in the 2023/24 season, compared to 2022/23. RESULTS: We estimated 9364-9875 RSV hospitalisations less than expected, corresponding to a 74%-75% reduction.

Assessment of effectiveness and impact of universal prophylaxis with nirsevimab for prevention of hospitalizations due to respiratory syncytial virus in infants. The NIRSE-GAL study protocol.

Nirsevimab has been recently licensed for universal RSV prophylaxis in infants. NIRSE-GAL is a three-year population-based study initiated in Galicia in September 2023. It aims to evaluate nirsevimab effectiveness against RSV-related hospitalizations lower respiratory tract infections (LRTI), severe RSV, all-cause LRTI, and all-cause hospitalization. NIRSE-GAL also aims to estimate nirsevimab impact on primary healthcare use in the short and mid-term, children's wheezing and asthma, and medical prescriptions for RSV. The immunization campaigns will be scheduled based on the expected start week for the RSV season and will last the whole season. Immunization will be offered to: i) infants born during the campaign (seasonal), ii) infants < 6 months at the start of the campaign (catch-up), and iii) infants with high-risk factors, aged 6-24 months at the start of the campaign (high-risk). The follow-up period will start: i) the immunization date for all immunized infants, ii) the start of the campaign, for the non-immunized catch-up or high-risk groups, or iii) the birthdate for the non-immunized seasonal group. Infants will be followed up until outcome occurrence, death, or end of study. Nirsevimab effectiveness will be estimated using Poisson and Cox regression models. Sensitivity and stratified analyses will be undertaken. The number of averted cases and the number needed to immunize will be estimated. Immunization failure and nirsevimab safety will be monitored. NIRSE-GAL was approved by the ethics committee of Galicia (CEIC 2023-377) and registered in ClinicalTrials.gov (ID: NCT06180993). Findings will be mainly shared via peer-reviewed publications and scientific conferences.

Short- and mid-term morbidity and primary-care burden due to infant respiratory syncytial virus infection: A Spanish 6-year population-based longitudinal study.

BACKGROUND: The morbidity burden of respiratory syncytial virus (RSV) in infants extends beyond hospitalization. Defining the RSV burden before implementing prophylaxis programs is essential for evaluating any potential impact on short- to mid-term morbidity and the utilization of primary healthcare (PHC) and emergency services (ES). We established this reference data using a population-based cohort approach. METHODS: Infants hospitalized for RSV from January 2016 to March 2023 were matched with non-hospitalized ones based on birthdate and sex. We defined the exposure as severe RSV hospitalization. The main study outcomes were as follows: (1) PHC and ES visits for RSV, categorized using the International Classification of Primary Care codes, (2) prescriptions for respiratory airway obstructive disease, and (3) antibacterial prescriptions. Participants were followed up from 30 days before hospitalization for severe RSV until the outcome occurrence or end of the study. Adjusted incidence rate ratios (IRRs) of the outcomes along with their 95% confidence intervals (CI) were estimated using Poisson regression models. Stratified analyses by type of PHC visit (nurse, pediatrician, or pharmacy) and follow-up period were undertaken. We defined mid-term outcomes as those taking place up to 24 months of follow-up period. RESULTS: The study included 6626 children (3313 RSV-hospitalized; 3313 non-hospitalized) with a median follow-up of 53.7 months (IQR = 27.9, 69.4). After a 3-month follow-up, severe RSV was associated with a considerable increase in PHC visits for wheezing/asthma (IRR = 4.31, 95% CI: 3.84-4.84), lower respiratory infections (IRR = 4.91, 95% CI: 4.34-5.58), and bronchiolitis (IRR = 4.68, 95% CI: 2.93-7.65). Severe RSV was also associated with more PHC visits for the pediatrician (IRR = 2.00, 95% CI: 1.96-2.05), nurse (IRR = 1.89, 95% CI: 1.75-1.92), hospital emergency (IRR = 2.39, 95% CI: 2.17-2.63), primary healthcare emergency (IRR: 1.54, 95% CI: 1.31-1.82), as well as with important increase in prescriptions for obstructive airway diseases (IRR = 5.98, 95% CI: 5.43-6.60) and antibacterials (IRR = 4.02, 95% CI: 3.38-4.81). All findings remained substantial until 2 years of post-infection. CONCLUSIONS: Severe RSV infection in infants significantly increases short- to mid-term respiratory morbidity leading to an escalation in healthcare utilization (PHC/ES attendance) and medication prescriptions for up to 2 years afterward. Our approach could be useful in assessing the impact and cost-effectiveness of RSV prevention programs.

Effectiveness and impact of universal prophylaxis with nirsevimab in infants against hospitalisation for respiratory syncytial virus in Galicia, Spain: initial results of a population-based longitudinal study.

BACKGROUND: Galicia (Spain) was one of the first regions worldwide to incorporate nirsevimab for universal respiratory syncytial virus (RSV) prophylaxis in infants into its immunisation programme. The NIRSE-GAL longitudinal population-based study aimed to assess nirsevimab effectiveness in preventing hospitalisations (ie, admittance to hospital). METHODS: The 2023-24 immunisation campaign with nirsevimab in Galicia began on Sept 25, 2023, and concluded on March 31, 2024. The campaign targeted three groups: infants born during the campaign (seasonal group), infants younger than 6 months at the start of the campaign (catch-up group), and infants aged 6-24 months with high-risk factors at the start of the campaign (high-risk group). Infants in the seasonal group were offered immunisation on the first day of life before discharge from hospital. Infants in the catch-up and high-risk groups received electronic appointments to attend a public hospital or health-care centre for nirsevimab administration. For this interim analysis, we used data collected from Sept 25 to Dec 31, 2023, from children born up to Dec 15, 2023. Data were retrieved from public health registries. Nirsevimab effectiveness in preventing RSV-associated lower respiratory tract infection (LRTI) hospitalisations; severe RSV-related LRTI requiring intensive care unit admission, mechanical ventilation, or oxygen support; all-cause LRTI hospitalisations; and all-cause hospitalisations was estimated using adjusted Poisson regression models. Data from five past RSV seasons (2016-17, 2017-18, 2018-19, 2019-20, and 2022-23), excluding the COVID-19 pandemic period, were used to estimate the number of RSV-related LRTI hospitalisations averted along with its IQR. The number needed to immunise to avoid one case in the 2023-24 season was then estimated from the averted cases. Nirsevimab safety was routinely monitored. The NIRSE-GAL study protocol was registered on ClinicalTrials.gov (NCT06180993), and follow-up of participants is ongoing. FINDINGS: 9408 (91·7%) of 10 259 eligible infants in the seasonal and catch-up groups received nirsevimab, including 6220 (89·9%) of 6919 in the seasonal group and 3188 (95·4%) of 3340 in the catch-up group. 360 in the high-risk group were offered nirsevimab, 348 (97%) of whom received it. Only infants in the seasonal and catch-up groups were included in analyses to estimate nirsevimab effectiveness and impact because there were too few events in the high-risk group. In the catch-up and seasonal groups combined, 30 (0·3%) of 9408 infants who received nirsevimab and 16 (1·9%) of 851 who did not receive nirsevimab were hospitalised for RSV-related LRTI, corresponding to an effectiveness of 82·0% (95% CI 65·6-90·2). Effectiveness was 86·9% (69·1-94·2) against severe RSV-related LRTI requiring oxygen support, 69·2% (55·9-78·0) against all-cause LRTI hospitalisations, and 66·2% (56·0-73·7) against all-cause hospitalisations. Nirsevimab effectiveness against other endpoints of severe RSV-related LRTI could not be estimated because of too few events. RSV-related LRTI hospitalisations were reduced by 89·8% (IQR 87·5-90·3), and the number needed to immunise to avoid one RSV-related LRTI hospitalisation was 25 (IQR 24-32). No severe adverse events related to nirsevimab were registered. INTERPRETATION: Nirsevimab substantially reduced infant hospitalisations for RSV-associated LRTI, severe RSV-associated LRTI requiring oxygen, and all-cause LRTI when given in real-world conditions. These findings offer policy makers and health authorities robust, real-world, population-based evidence to guide the development of strategies for RSV prevention. FUNDING: Sanofi and AstraZeneca. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

Effectiveness of Modified Vaccinia Ankara-Bavaria Nordic Vaccination in a Population at High Risk of Mpox: A Spanish Cohort Study.

BACKGROUND: With more than 7500 cases reported since April 2022, Spain has experienced the highest incidence of mpox in Europe. From 12 July onward, the modified vaccinia Ankara-Bavaria Nordic (MVA-BN) smallpox vaccine was offered as pre-exposure prophylaxis for those receiving pre-exposure prophylaxis for human immunodeficiency virus (HIV-PrEP). Our aim was to assess the effectiveness of 1 dose of MVA-BN vaccine as pre-exposure prophylaxis against mpox virus (MPXV) infection in persons on HIV-PrEP. METHODS: National retrospective cohort study between 12 July and 12 December 2022. Individuals aged ≥18 years receiving HIV-PrEP as of 12 July with no previous MPXV infection or vaccination were eligible. Each day, we matched individuals receiving a first dose of vaccine and unvaccinated controls of the same age and region. We used a Kaplan-Meier estimator, calculated risk ratios (RR) and vaccine effectiveness (VE = [1 - RR]x100). RESULTS: We included 5660 matched pairs, with a median follow-up of 62 days (interquartile range, 24-97). Mpox cumulative incidence was 5.6 per 1000 (25 cases) in unvaccinated and 3.5 per 1000 (18 cases) in vaccinated. No effect was found during days 0-6 post-vaccination (VE, -38.3; 95% confidence interval [CI], -332.7 to 46.4), but VE was 65% at ≥7 days (95% CI, 22.9 to 88.0) and 79% at ≥14 days (95% CI, 33.3 to 100.0) post-vaccination. CONCLUSIONS: One dose of MVA-BN vaccine offered protection against mpox in most-at-risk population shortly after the vaccination. Further studies need to assess the VE of a second dose and the duration of protection over time.

[Impact of COVID-19 pandemic in terms of incidence and lethality in nursing homes in Galicia (Spain)]. / Impacto de la pandemia de COVID-19 en términos de incidencia y letalidad en los centros residenciales de mayores de Galicia.

OBJECTIVES: To know the impact of COVID-19 in incidence and lethality in nursing homes in Galicia. METHODS: This is a descriptive study of nursing homes residents and workers with confirmed COVID-19. The analysis spanned from March 1, 2020 to March 27, 2022, stratified into 6 periods (one per wave). The impact on incidence (attack rate, number of outbreaks, reinfections, sex, age, and diagnostic technique) and lethality (by sex, age, place of death, and number of centers with deaths) was analyzed. RESULTS: There were 15,819 people affected, 51.9% of the jobs and 47.0% of the workers. The attack rate in residents was: 5.8% in the first wave, 10.4% in the second, 6.3% in the third, 0.1% in the fourth, 2.1% in the fifth and 27.3% in the sixth. In the sixth wave, there were 11.3% reinfections and the number of outbreaks in was 3 times higher than in the second. The case fatality in residents was higher during the first wave (21.8%) and lower during the sixth (2.4%). He only had one worker in relation to COVID-19. CONCLUSIONS: Surveillance of COVID-19 in nursing homes was essential to understand the dynamics of the disease. The sixth wave was the one with the highest incidence and the lowest lethality. Lethality was higher in the first wave. The fourth and fifth waves had a lower incidence due to the effects of vaccination.

Impacto de la pandemia de COVID-19 en términos de incidencia y letalidad en los centros residenciales de mayores de Galicia / Impact of COVID-19 pandemic in terms of incidence and lethality in nursing homes in Galicia (Spain)

Objetivos: Conocer el impacto de la COVID-19 en incidencia y letalidad en los centros residenciales de mayores (CRM) de Galicia. Métodos: Se trata de un estudio descriptivo en residentes y trabajadores de los CRM con COVID-19 confirmada. El análisis abarcó del 1 de marzo de 2020 al 27 de marzo de 2022 y se estratificó en 6 períodos (uno por ola). Se analizó el impacto en incidencia (tasa de ataque, número de brotes, reinfecciones, sexo, edad y técnica diagnóstica) y letalidad (por sexo, edad, lugar de fallecimiento y número de centros con fallecidos). Resultados: Hubo 15.819 personas afectadas, el 51,9% de las plazas y el 47% de los trabajadores. La tasa de ataque en residentes fue: 5,8% en la primera ola, 10,4% en la segunda, 6,3% en la tercera, 0,1% en la cuarta, 2,1% en la quinta y 27,3% en la sexta ola. En la sexta ola hubo un 11,3% de reinfecciones y el número de brotes fue 3 veces mayor que en la segunda. La letalidad en residentes fue mayor durante la primera ola (21,8%) y menor durante la sexta (2,4%). Solo falleció un trabajador en relación con la COVID-19. Conclusiones: La vigilancia de la COVID-19 en CRM fue fundamental para conocer la dinámica de la enfermedad. La sexta ola fue la de mayor incidencia y la de menor letalidad. La letalidad fue superior en la primera ola. La cuarta y la quinta ola tuvieron menor incidencia debido a los efectos de la vacunación. (AU)

Objectives: To know the impact of COVID-19 in incidence and lethality in nursing homes in Galicia. Methods: This is a descriptive study of nursing homes residents and workers with confirmed COVID-19. The analysis spanned from March 1, 2020 to March 27, 2022, stratified into 6 periods (one per wave). The impact on incidence (attack rate, number of outbreaks, reinfections, sex, age, and diagnostic technique) and lethality (by sex, age, place of death, and number of centers with deaths) was analyzed. Results: There were 15,819 people affected, 51.9% of the jobs and 47.0% of the workers. The attack rate in residents was: 5.8% in the first wave, 10.4% in the second, 6.3% in the third, 0.1% in the fourth, 2.1% in the fifth and 27.3% in the sixth. In the sixth wave, there were 11.3% reinfections and the number of outbreaks in was 3 times higher than in the second. The case fatality in residents was higher during the first wave (21.8%) and lower during the sixth (2.4%). He only had one worker in relation to COVID-19. Conclusions: Surveillance of COVID-19 in nursing homes was essential to understand the dynamics of the disease. The sixth wave was the one with the highest incidence and the lowest lethality. Lethality was higher in the first wave. The fourth and fifth waves had a lower incidence due to the effects of vaccination. (AU)

Características al diagnóstico y supervivencia de estadios I y II de cáncer de pulmón / Description and Survival of Stage I and II Lung Cancer Patients

Introducción: El objetivo de nuestro estudio es detallar las características de los pacientes diagnosticados en estadios I y II de cáncer de pulmón en el área sanitaria de A Coruña (Galicia) y conocer su supervivencia global en función de ciertas variables. Métodos: Serie de casos de carácter retrospectivo en sujetos diagnosticados entre enero de 2011 y diciembre de 2015 de cáncer pulmonar primario en estadios I y II con un seguimiento mínimo de 18 meses. Resultados: Se incluyeron 158 pacientes, 99 en estadio i, con una edad mediana de 69 años (rango 20-90) y mayoritariamente hombres (81%). El adenocarcinoma fue la histología más frecuente (52,9%) por encima del carcinoma epidermoide (33,1%). Los sujetos asintomáticos (35,9%) se presentaron más frecuentemente en estadio i. La mediana de supervivencia fue de 57 meses (IC 95%: 48,1-65,9), con una mayor supervivencia para el sexo femenino, los menores de 70 años y los pacientes que recibieron tratamiento quirúrgico. Conclusiones: El cáncer de pulmón en estadios iniciales en el área de sanitaria de A Coruña presenta un predominio de hombres, edad avanzada y mayoritariamente adenocarcinomas. La supervivencia fue mayor en el estadio i, mujeres, menores de 70 años y subsidiarios de tratamiento quirúrgico. Pese a este diagnóstico precoz, la mediana de supervivencia no alcanza los 5 años

Introduction: The objective of our study was to describe the characteristics of patients diagnosed with stage I and II lung cancer in the health area of A Coruña (Galicia) and to determine their overall survival according to certain variables. Methods: Retrospective case series in patients diagnosed between January 2011 and December 2015 with stage I and II primary lung cancer with a minimum follow-up of 18 months. Results: 158 patients were included, 99 at stage I, with a median age of 69 years (range 20-90), predominantly men (81%). Adenocarcinoma was the most common histology (52.9%), followed by epidermoid carcinoma (33.1%). Asymptomatic patients (35.9%) presented more frequently in stage I. Median survival was 57 months (95% CI 48.1-65.9), with higher survival among women, patients under 70 years of age, and those who received surgical treatment. Conclusions: Early stage lung cancer in the health area of A Coruña occurs predominantly in men, in advanced age, and with adenocarcinoma histology. Survival was greater among patients with stage I disease, women, individuals aged under 70 years, and those treated surgically. Despite early diagnosis, median survival was less than 5 years

Description and Survival of Stage I and II Lung Cancer Patients. / Características al diagnóstico y supervivencia de estadios i y ii de cáncer de pulmón.

INTRODUCTION: The objective of our study was to describe the characteristics of patients diagnosed with stage I and II lung cancer in the health area of A Coruña (Galicia) and to determine their overall survival according to certain variables. METHODS: Retrospective case series in patients diagnosed between January 2011 and December 2015 with stage I and II primary lung cancer with a minimum follow-up of 18 months. RESULTS: 158 patients were included, 99 at stage I, with a median age of 69 years [range 20-90], predominantly men (81%). Adenocarcinoma was the most common histology (52.9%), followed by epidermoid carcinoma (33.1%). Asymptomatic patients (35.9%) presented more frequently in stage I. Median survival was 57 months (95% CI 48.1-65.9), with higher survival among women, patients under 70 years of age, and those who received surgical treatment. CONCLUSIONS: Early stage lung cancer in the health area of A Coruña occurs predominantly in men, in advanced age, and with adenocarcinoma histology. Survival was greater among patients with stage I disease, women, individuals aged under 70 years, and those treated surgically. Despite early diagnosis, median survival was less than 5 years.