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Introduction: Respiratory syncytial virus (RSV) infection is one of the main causes of morbidity and mortality from lower respiratory tract infections in children under 5 years of age worldwide. Given that, the objective of this study was estimate the effectiveness of nirsevimab (a single-dose, long-acting, human recombinant monoclonal antibody against RSV) over time for the prevention of respiratory episodes treated at different levels of care. Methods: A prospective and dynamic population-based cohort study was performed including infants born between April 1 and December 31, 2023, in the Madrid region who resided there during the follow-up period from October 1, 2023, to February 29, 2024. Infants were considered immunized from the day after receiving one dose (50 or 100 mg) of nirsevimab or nonimmunized individuals if they did not receive any dose. Results: There were 4,100 episodes of primary care, 1,954 hospital emergencies, and 509 admissions, 82 of which required intensive care in the 33,859 participants analyzed. The adjusted effectiveness of nirsevimab in preventing hospitalization due to RSV infection was 93.6% (95% CI: 89.7 to 96.1) at 30 days and 87.6% (95% CI: 67.7 to 95.3) at 150 days. The number needed to treat to prevent one hospitalization were 314.19 (95% CI: 306.22 to 327.99) at 30 days and 24.30 (95% CI: 22.31 to 31.61) at 150 days. The adjusted effectiveness of nirsevimab in avoiding admission to an intensive care unit was 94.4% (95% CI: 87.3 to 97.5) at 30 days and 92.1% (95% CI: 64.0 to 98.3) at 90 days. The adjusted effectiveness of nirsevimab for avoiding primary care consultations and hospital emergency visits was lower. Discussion: Immunization with nirsevimab is an effective measure for reducing the burden of care related to RSV at all levels of care albeit it decreases throughout follow-up. At 150 days it remained high for preventing hospital admissions. Other articles already published have also demonstrated high effectiveness although with preliminary results, short follow-up periods and wide confidence intervals. None have detected a decrease in effectiveness over time. These results can be quite useful in individual infant prevention and in the design of immunization campaigns.
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Antivirales , Infecciones por Virus Sincitial Respiratorio , Humanos , Infecciones por Virus Sincitial Respiratorio/prevención & control , Infecciones por Virus Sincitial Respiratorio/tratamiento farmacológico , España , Estudios Prospectivos , Lactante , Femenino , Masculino , Antivirales/uso terapéutico , Hospitalización/estadística & datos numéricos , Costo de Enfermedad , Anticuerpos Monoclonales Humanizados/uso terapéutico , Preescolar , Recién NacidoRESUMEN
BACKGROUND: Respiratory syncytial virus (RSV) is associated with substantial morbidity among infants. This study modelled the potential public health and economic impact of nirsevimab, a long-acting monoclonal antibody, as an immunoprophylactic strategy for all infants in Spain in their first RSV season. METHODS: A static decision-analytic model of the Spanish birth cohort during its first RSV season was developed to estimate the impact of nirsevimab on RSV-related health events and costs versus the standard of practice (SoP). Spain-specific costs and epidemiological data were used as model inputs. Modelled outcomes included RSV-related outpatient visits, emerging room (ER) visits, hospitalisations - including pediatric intensive care unit (PICU) admission, mechanical ventilation, and inpatient mortality. RESULTS: Under the current SoP, RSV caused 151,741 primary care visits, 38,798 ER visits, 12,889 hospitalisations, 1,412 PICU admissions, and 16 deaths over a single season, representing a cost of 71.8 million from a healthcare payer perspective. Universal immunisation of all infants with nirsevimab was expected to prevent 97,157 primary care visits (64.0% reduction), 24,789 ER visits (63.9%), 8,185 hospitalisations (63.5%), 869 PICU admissions (61.5%), and 9 inpatient deaths (52.6%), saving 47.8 million (62.4%) in healthcare costs. CONCLUSIONS: These results suggest that immunisation with nirsevimab of all infants experiencing their first RSV season in Spain is likely to prevent thousands of RSV-related health events and save considerable costs versus the current SoP.
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Anticuerpos Monoclonales Humanizados , Infecciones por Virus Sincitial Respiratorio , Humanos , Infecciones por Virus Sincitial Respiratorio/prevención & control , Infecciones por Virus Sincitial Respiratorio/economía , España/epidemiología , Lactante , Recién Nacido , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/economía , Hospitalización/estadística & datos numéricos , Hospitalización/economía , Femenino , Masculino , Antivirales/uso terapéutico , Antivirales/economía , Costos de la Atención en Salud/estadística & datos numéricosRESUMEN
BACKGROUND AND AIM: Respiratory syncytial virus (RSV) is a leading cause of hospitalization of infants with respiratory infections. A new immunization using monoclonal antibodies (mAbs) may offer protection against RSV infections. A study was conducted across eight countries to gain insight into parental awareness of RSV, their sources of child health information, and attitudes toward infant immunization against RSV using mAbs. This paper presents the findings from France. METHODS: In 2021, a survey was conducted in eight countries among expecting and current parents with children younger than 24 months of age. Eligible respondents included parents who were open to childhood immunizations, i.e., they had given or planned to give their children "all," "most," or "some" immunizations. RESULTS: In France, the survey respondents had high adoption rates for childhood immunizations. Key drivers behind these high rates were the desire to protect their children from severe diseases and adherence to mandatory immunizations, whereas concerns about safety were the main barriers. While general practitioners and pediatricians were key sources of advice on child health, many parents also requested information about immunizations from health authorities and nurses. Sources of advice varied with parental age, gender, educational level, and income. The majority of parents had no knowledge about mAbs or passive immunization, and the overall awareness of RSV was low. When informed about RSV and mAbs, most parents held neutral to positive attitudes toward nirsevimab for their infants if recommended by a healthcare professional and/or included in the immunization program. These findings were further confirmed by the 60 %-80 % uptake rates of nirsevimab following the introduction in September 2023.
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BACKGROUND: Nirsevimab is an extended half-life monoclonal antibody (mAb) licensed for the prevention of respiratory syncytial virus (RSV)-associated lower respiratory tract disease in neonates, infants and medically vulnerable children. We characterized RSV isolates recovered from participants enrolled in MEDLEY: a randomized, palivizumab-controlled phase 2/3 trial of nirsevimab in infants born preterm and/or with congenital heart disease or chronic lung disease of prematurity. METHODS: Participants were assessed in two RSV seasons (Season 1 and 2). Season 1 participants were randomized (2:1) to receive a single dose of nirsevimab (50 mg if weight <5 kg or 100 mg if weight ≥5 kg in Season 1; 200 mg in Season 2) followed by four monthly doses of placebo, or five once-monthly doses of palivizumab (15 mg/kg weight per dose). Season 2 participants continued nirsevimab and placebo (nirsevimab/nirsevimab) or were re-randomized (1:1) to switch to nirsevimab (palivizumab/nirsevimab) or continue palivizumab (palivizumab/palivizumab). Cases of RSV infection were identified by central testing of nasal swabs from participants seeking medical attention for respiratory illnesses. Nirsevimab and palivizumab binding site substitutions were assessed via microneutralization assay. RESULTS: Twenty-five cases of confirmed RSV infection were observed during the trial and sequenced: 12 in nirsevimab recipients and 10 in palivizumab recipients during Season 1, and 1 case in each Season 2 group. Molecular sequencing of RSV A (n = 14) isolates detected no nirsevimab binding site substitutions, and 3 palivizumab neutralization-resistant substitutions (Lys272Met, Lys272Thr, Ser275Leu). The nirsevimab binding site Ile206Met:Gln209Arg and Ile206Met:Gln209Arg:Ser211Asn substitutions were the only anti-RSV mAb binding site substitutions detected among RSV B isolates (n = 11). Nirsevimab neutralized all nirsevimab and palivizumab binding site substitutions in RSV A and B isolates recovered from MEDLEY participants. CONCLUSION: No binding site substitution detected during MEDLEY affected RSV susceptibility to nirsevimab neutralization.
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Anticuerpos Monoclonales Humanizados , Antivirales , Palivizumab , Infecciones por Virus Sincitial Respiratorio , Virus Sincitial Respiratorio Humano , Humanos , Palivizumab/uso terapéutico , Palivizumab/administración & dosificación , Infecciones por Virus Sincitial Respiratorio/prevención & control , Lactante , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/administración & dosificación , Antivirales/uso terapéutico , Antivirales/administración & dosificación , Método Doble Ciego , Masculino , Virus Sincitial Respiratorio Humano/inmunología , Virus Sincitial Respiratorio Humano/efectos de los fármacos , Virus Sincitial Respiratorio Humano/genética , Femenino , Recién Nacido , Anticuerpos Antivirales/inmunología , Preescolar , Anticuerpos Neutralizantes/inmunología , Anticuerpos Neutralizantes/sangreRESUMEN
INTRODUCTION: Monoclonal antibodies (mAbs) and other biological agents are being increasingly approved in the last years with very different indications. Their highly heterogeneous immunosuppressive effects, mechanisms of action and pharmacokinetics require comprehensive individualized vaccination schedules. AREAS COVERED: Vaccination for immunocompromised patients. Prevention and treatment with mAbs and other biological therapies. EXPERT OPINION: Current recommendations on vaccine schedules for patients under mAbs or other biological treatments are based on expert opinions and are not individualized according to each vaccine and treatment. No studies are focusing on the high heterogeneity of these agents, that are exponentially developed and used for many different indications. Recent paradigm changes in vaccine development (boosted by the COVID-19 pandemic) and in the mAbs use for prophylactic purposes (changing 'vaccination' by 'immunization' schedules) has been witnessed in the last years. We aimed at collecting all mAbs used for treatment or prevention, approved as of 1 January 2024, by the EMA. Based on available data on mAbs and vaccines, we propose a comprehensive guide for personalizing vaccination. Recent vaccine developments and current population strategies (e.g. zoster vaccination or prophylactic nirsevimab) are discussed. This review aims to be a practical guideline for professionals working in vaccine consultations for immunosuppressed patients.
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INTRODUCTION: Respiratory syncytial virus (RSV) leads to significant morbidity in newborn infants in the United Kingdom (UK). Nirsevimab, a long-acting monoclonal antibody, received approval from the European Medicines Agency and has been licensed by the Medicines and Healthcare products Regulatory Agency for preventing RSV lower respiratory tract disease (LRTD) in neonates and infants during their first RSV season. The objective of this study was to assess the potential impact of nirsevimab on RSV-associated LRTDs, related costs, and loss of quality-adjusted life years (QALYs) in infants experiencing their first RSV season. METHODS: The impact of administering nirsevimab across all infant populations compared to palivizumab in the high-risk palivizumab-eligible population was assessed via a static decision-analytic model specified for a UK birth cohort experiencing their first RSV season. The RSV-related health events of interest included primary care (PC), accident and emergency (A&E) visits, hospitalizations [including hospitalizations alone and those resulting in intensive care unit (ICU) admissions], recurrent wheezing in infants who were previously hospitalized, and all-cause LRTD hospitalizations. RESULTS: Under the current standard of practice (SoP), RSV was estimated to result in 329,425 RSV LRTDs annually, including 24,381 hospitalizations and ICU admissions, representing £117.8 million (2024 GBP) in costs. Comparatively, universal immunization of all infants with nirsevimab could avoid 198,886 RSV LRTDs, including 16,657 hospitalizations and ICU admissions, resulting in savings of £77.2 million in RSV treatment costs. Considering the impact on all-cause LRTD of a universal immunization strategy, nirsevimab could be valued between £243 and £274, assuming willingness-to-pay (WTP) thresholds of £20,000 and £30,000 per QALY saved, respectively. CONCLUSIONS: This analysis demonstrated that the health and economic burden of RSV would be substantially reduced in all infants experiencing their first RSV season in the UK (including term, preterm, and palivizumab-eligible infants) as a result of a universal immunization strategy with nirsevimab.
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Respiratory syncytial virus (RSV) is the main cause of low respiratory tract infections in infants under one year of age. In the 2023/2024 season, the monoclonal antibody nirsevimab was available to protect children from RSV, and Spain has become one of the first countries worldwide to implement this strategy. It is essential to evaluate the results of this first campaign and different characteristics of the immunized population in order to plan next campaigns, especially for countries that are going to include this immunization. Our coverage was high (91.5% for those born during the season and 88.3% globally). For those born during the season, only 4.9% preferred not to immunize at the maternity hospital, which meant an average delay of 27.45 days. We observed a lower coverage in the population of immigrant origin. There was a rapid pace of immunization, since for those born before the beginning of the campaign the mean to be immunized was 15.63 days, without differences between healthy and at-risk children. This allows immunization before the RSV season (90% of the catch-up children had been immunized on November 3). The average age at which all the immunized children have received nirsevimab was lower in healthy children compared to those with risk conditions (49.65 versus 232.85 days). For those born during the campaign, the average age was also lower in healthy children (3.14 versus 14.58 days). In conclusion, we consider that the implementation of the immunization strategy with nirsevimab in the Region of Murcia, Spain, has been a success.
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Infecciones por Virus Sincitial Respiratorio , Humanos , España , Infecciones por Virus Sincitial Respiratorio/prevención & control , Lactante , Femenino , Masculino , Programas de Inmunización , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/administración & dosificación , Recién Nacido , Virus Sincitial Respiratorio Humano/inmunología , Vacunas contra Virus Sincitial Respiratorio/inmunología , Vacunas contra Virus Sincitial Respiratorio/administración & dosificaciónRESUMEN
Background: Respiratory syncytial virus (RSV) is the leading cause of lower-respiratory-tract infection in children. Nirsevimab, a monoclonal antibody against RSV, was implemented in a few countries in September 2023. However, its post-license effectiveness in ambulatory care settings is unknown. We aimed to assess the effectiveness of nirsevimab against RSV-bronchiolitis in outpatients aged <12 months. Methods: We conducted a test-negative case-control study based on a national ambulatory surveillance system. We included all infants aged <12 months who had bronchiolitis and results of an RSV rapid antigen test performed, visiting a network of 107 ambulatory paediatricians from September 15, 2023, to February 1, 2024. Case patients were infants with bronchiolitis and a rapid antigen test positive for RSV. Control patients were infants with bronchiolitis and a rapid antigen test negative for RSV. Effectiveness was assessed by a logistic regression model adjusted for potential confounders. A range of sensitivity analyses were conducted to assess the robustness of the findings. Findings: We included 883 outpatients who had bronchiolitis and results of an RSV rapid antigen test (453 were case patients, and 430 were control patients). Overall, 62/453 (13.7%) case patients and 177/430 (41.2%) control patients had been previously immunised for nirsevimab. The adjusted effectiveness of nirsevimab against RSV-bronchiolitis was 79.7% (95% CI 67.7-87.3). Sensitivity analyses gave similar results. Interpretation: This post-license study indicates that nirsevimab was effective in preventing RSV-bronchiolitis in ambulatory care settings. Funding: The study was supported by Association Clinique et Thérapeutique Infantile du Val de Marne (ACTIV), French Pediatrician Ambulatory Association (AFPA) and unrestricted grants from GSK, MSD, Pfizer and Sanofi.
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Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory infections in children around the world. The post-pandemic era has resulted in a notable increase in reported cases of RSV infections, co-circulation of other respiratory viruses, shifts in epidemiology, altered respiratory season timing, and increased healthcare demand. Low- and middle-income countries are responsible for the highest burden of RSV disease, contributing significantly to health expenses during respiratory seasons and RSV-associated mortality in children. Until recently, supportive measures were the only intervention to treat or prevent RSV-infection, since preventive strategies like palivizumab are limited for high-risk populations. Advances in new available strategies, such as long-acting monoclonal antibodies during the neonatal period and vaccination of pregnant women, are now a reality. As the Regional Expert Group of the Latin American Pediatric Infectious Diseases Society (SLIPE), we sought to evaluate the burden of RSV infection in Latin America and the Caribbean (LAC) region, analyze current strategies to prevent RSV infection in children, and provide recommendations for implementing new strategies for preventing RSV infection in children in LAC region.
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Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory tract infections (LRTIs) and hospital admissions in early childhood. Recent advancements in novel preventive therapies, including extended half-life monoclonal antibodies and antenatal vaccination, have afforded new opportunities to significantly reduce the burden of this infection. Nirsevimab is a novel monoclonal antibody that provides sustained protection against RSV for at least 5 months among newborns and young children. It has received regulatory approval in numerous countries and is being implemented across various settings. Two pivotal Phase 3 trials (MELODY, HARMONIE) demonstrated significant reductions in RSV-associated LRTI hospitalisations following nirsevimab administration, with treatment efficacy of 62.1% and 83.2%. Emerging real-world data from early adopters of nirsevimab corroborates these findings. Studies from Spain, Luxembourg, France and the USA report effectiveness rates between 82% and 90% in preventing RSV-associated hospitalisations among infants entering their first RSV season. Current implementation strategies for nirsevimab have primarily focused on seasonal administration for all infants, aligned to local RSV seasons, and often include catch-up doses for those born before the season begins. Available cost-effectiveness analyses indicate that while nirsevimab offers significant potential public health benefits, its adoption must carefully consider economic factors such as treatment costs, implementation strategies tailored to local viral epidemiology, and logistics for vaccine delivery. Overall, nirsevimab presents a promising opportunity to alleviate the burden of severe RSV infections in young children. However, ongoing surveillance and refinements in implementation strategies are crucial to optimise its impact and ensure sustainability across diverse health-care settings.
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BACKGROUND: Health Canada recently authorized the RSVpreF pregnancy vaccine and nirsevimab to protect infants against respiratory syncytial virus (RSV) disease. OBJECTIVE: Assess the cost-effectiveness of RSVpreF and nirsevimab programs in preventing RSV disease in infants, compared to a palivizumab program. METHODS: We used a static cohort model of a Canadian birth cohort during their first RSV season to estimate sequential incremental cost-effectiveness ratios (ICERs) in 2023 Canadian dollars per quality-adjusted life year (QALY) for nine strategies implemented over a one-year time period, from the health system and societal perspectives. Sensitivity and scenario analyses were conducted to explore the impact of uncertainties on the results. RESULTS: All-infants nirsevimab programs averted more RSV-related outcomes than year-round RSVpreF programs, with the most RSV cases averted in a seasonal nirsevimab program with catch-up. Assuming list prices for these immunizing agents, all-infants nirsevimab and year-round RSVpreF programs were never cost-effective, with ICERs far exceeding commonly used cost-effectiveness thresholds. Seasonal nirsevimab with catch-up for infants born outside the RSV season was a cost-effective program if prioritized for infants at moderate/high-risk (ICER <$28,000 per QALY) or those living in settings with higher RSV burden and healthcare costs, such as remote communities where transport would be complex (ICER of $5700 per QALY). Using a $50,000 per QALY threshold, an all-infants nirsevimab program could be optimal if nirsevimab is priced at <$110-190 per dose. A year-round RSVpreF for all pregnant women and pregnant people plus nirsevimab for infants at high-risk was optimal if nirsevimab is priced at >$110-190 per dose and RSVpreF priced at <$60-125 per dose. INTERPRETATION: Prophylactic interventions can substantially reduce RSV disease in infants, and more focused nirsevimab programs are the most cost-effective option at current product prices.
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Anticuerpos Monoclonales Humanizados , Análisis Costo-Beneficio , Palivizumab , Años de Vida Ajustados por Calidad de Vida , Infecciones por Virus Sincitial Respiratorio , Vacunas contra Virus Sincitial Respiratorio , Humanos , Infecciones por Virus Sincitial Respiratorio/prevención & control , Infecciones por Virus Sincitial Respiratorio/economía , Lactante , Canadá , Vacunas contra Virus Sincitial Respiratorio/economía , Vacunas contra Virus Sincitial Respiratorio/uso terapéutico , Vacunas contra Virus Sincitial Respiratorio/administración & dosificación , Anticuerpos Monoclonales Humanizados/economía , Anticuerpos Monoclonales Humanizados/uso terapéutico , Palivizumab/uso terapéutico , Palivizumab/economía , Femenino , Antivirales/economía , Antivirales/uso terapéutico , Virus Sincitial Respiratorio Humano/inmunología , Virus Sincitial Respiratorio Humano/efectos de los fármacos , Masculino , Recién NacidoRESUMEN
BACKGROUND: A new monoclonal antibody (nirsevimab; Beyfortus®) and a bivalent prefusion RSV vaccine (Abrysvo®) for maternal immunization have been approved recently. This is a modelling study to estimate the potential impact of different immunization programs with these products on RSV-bronchiolitis. METHODS: Population-based real-world data from primary care and hospitalizations were considered. RSV bronchiolitis dynamics in absence of these immunization scenarios were explained by a multivariate age-structured Bayesian model. Then, the potential impact was simulated under different assumptions including the most recent clinical trial data. Differences in endpoints, populations, and timeframes between trials make the two products' efficacy difficult to compare. RESULTS: A seasonal with catch-up program, assuming a constant effectiveness of 79.5 % during the first 5 months followed by a linear decay to 0 by month 10 with nirsevimab, would prevent between 5121 and 8846 RSV bronchiolitis per 100,000 infants-years. Assuming 77.3 % effectiveness with the same decay, between 976 and 1686 RSV-hospitalizations per 100,000 infants-years could be prevented depending on the uptake. A year-round maternal immunization program, with 51 % of effectiveness during the first 6 months followed by a linear decay to 0 by month 10 would prevent between 3246 and 5606 RSV bronchiolitis cases per 100,000 infants-years. Assuming 56.9 % effectiveness with the same decay, between 713 and 1231 RSV-hospitalizations per 100,000 infants-years could be prevented. CONCLUSIONS: Our results suggest that each strategy would effectively reduce RSV-bronchiolitis.
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Hospitalización , Infecciones por Virus Sincitial Respiratorio , Vacunas contra Virus Sincitial Respiratorio , Humanos , Infecciones por Virus Sincitial Respiratorio/prevención & control , Lactante , Vacunas contra Virus Sincitial Respiratorio/inmunología , Vacunas contra Virus Sincitial Respiratorio/administración & dosificación , Femenino , Hospitalización/estadística & datos numéricos , Masculino , Bronquiolitis/prevención & control , Bronquiolitis Viral/prevención & control , Anticuerpos Monoclonales Humanizados/uso terapéutico , Recién Nacido , Programas de Inmunización , Anticuerpos Monoclonales/uso terapéuticoRESUMEN
INTRODUCTION: Human respiratory syncytial virus (RSV) is the most commonly identified virus associated with lower respiratory tract infections. The monoclonal antibody nirsevimab immunization campaign began in our country in October 2023. METHODS: This study was conducted in the Pediatric Emergency Department (PED) of a tertiary care center in Madrid, Spain. The aim was to compare PED visits of patients eligible for immunization with nirsevimab who attended between weeks 40 and 52 of 2022 and 2023 and who had a confirmed diagnosis of RSV infection. RESULTS: During the study period, 264 out of 765 patients with confirmed RSV infection who attended the PED were eligible for immunization with nirsevimab and were selected for our analysis. The PED attendance was 80.3% in 2022 and 19.7% in 2023. The number of RSV-positive cases increased from week 42 in both analyzed periods, with a peak of maximum incidence between weeks 46 and 48. In 2022, the morphology of the case curve in the group of children eligible for immunization was similar to the overall curve. However, in 2023, we did not observe a similar increase in cases among patients eligible for immunization. CONCLUSION: Immunization with nirsevimab during the 2023 RSV epidemic season had a beneficial effect, reducing the number of PED consultations for RSV infection.
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Servicio de Urgencia en Hospital , Infecciones por Virus Sincitial Respiratorio , Centros de Atención Terciaria , Humanos , Infecciones por Virus Sincitial Respiratorio/prevención & control , Infecciones por Virus Sincitial Respiratorio/epidemiología , España/epidemiología , Servicio de Urgencia en Hospital/estadística & datos numéricos , Lactante , Masculino , Femenino , Preescolar , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/administración & dosificación , NiñoRESUMEN
BACKGROUND: Respiratory syncytial virus (RSV), a highly transmissible virus, is the leading cause of lower respiratory tract infections. We examined molecular changes in the RSV genome before and after the coronavirus disease 2019 (COVID-19) pandemic in Korea, and investigated whether drug-resistant mutations were present. METHODS: In this prospective, single-center study, RSV-positive respiratory samples were collected between September 2019 and December 2022. Long-read whole-genome sequencing (WGS) was performed, and the presence of known drug-resistant substitutions for palivizumab, nirsevimab, and suptavumab was investigated. RESULTS: Overall, 288 respiratory samples were collected from 276 children. WGS data were available for 133 samples (71 and 62 samples from the pre- and post-pandemic periods, respectively). All RSV-A strains (n = 56) belonged to the GA2.3.5 (ON1) genotype, whereas all RSV-B strains (n = 77) belonged to the GB5.0.5a (BA) genotype. No significant differences in genotypes were observed between the pre- and post-pandemic periods. In addition, no notable mutations related to nirsevimab or palivizumab resistance were detected in the F gene. However, the L172Q and S173L substitutions, which are known to confer resistance to suptavumab, were present in all RSV-B samples. CONCLUSION: Despite the unprecedented interruption of RSV seasonality, there were no significant molecular changes in circulating RSV strains in Korea related to nirsevimab or palivizumab resistance before and after the COVID-19 pandemic. However, RSV-specific drug-resistance substitutions for suptavumab were identified.
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COVID-19 , Genotipo , Infecciones por Virus Sincitial Respiratorio , Virus Sincitial Respiratorio Humano , SARS-CoV-2 , Secuenciación Completa del Genoma , Humanos , Estudios Prospectivos , República de Corea/epidemiología , COVID-19/virología , COVID-19/epidemiología , Infecciones por Virus Sincitial Respiratorio/epidemiología , Infecciones por Virus Sincitial Respiratorio/virología , SARS-CoV-2/genética , SARS-CoV-2/aislamiento & purificación , Virus Sincitial Respiratorio Humano/genética , Virus Sincitial Respiratorio Humano/aislamiento & purificación , Farmacorresistencia Viral/genética , Antivirales/uso terapéutico , Genoma Viral , Palivizumab/uso terapéutico , Femenino , Mutación , Masculino , Niño , Preescolar , Lactante , Anticuerpos Monoclonales Humanizados/uso terapéuticoRESUMEN
RSV bronchiolitis remains the leading cause of hospitalization in children under 1 year of age. It is estimated that 2-6% of cases will be hospitalized on pediatric intensive care units (PICUs). In October 2023, a universal immunization program with the monoclonal antibody nirsevimab was implemented in Catalonia. The aim of the study was to analyze the impact of the nirsevimab immunization on the burden of bronchiolitis admitted to a PICU and resulting changes in epidemiological, clinical, and microbiological characteristics comparing the pre-nirsevimab (pre-N) with the post-nirsevimab (post-N) period. This was a prospective, descriptive, and observational study. Patients with severe bronchiolitis admitted to reference children's hospital PICU, between September 2010 and February 2024 were included. Demographic and clinical data were collected and viral laboratory etiological diagnosis was carried out. 1531 patients were recruited, 1458 in the pre-N seasons and 73 after its introduction (58% males, median age 52 days), of which 67% were immunized with nirsevimab. The total number of PICU bronchiolitis admissions, the ratio, and the RSV etiology were significantly lower in the post-N period (p = 0.03, p < 0.001, and p = 0.039, respectively). Significant higher age at admission (p < 0.001) and lower hospital length of stay (p < 0.001) was observed comparing pre-N vs. post-N period. CONCLUSION: Nirsevimab appears to have an important impact on reducing the number and length of stay of PICU admissions due to RSV bronchiolitis. WHAT IS KNOWN: ⢠Bronchiolitis is the most common viral infection of the lower respiratory tract in infants. ⢠It represents 13% of the total pediatric intensive care admissions, typically during winter. This is one of the causes that produces a collapse in the health care systems all around the world. WHAT IS NEW: ⢠In October 2023, universal immunization with monoclonal antibody nirsevimab of all children under 6 months of age was started in the majority of autonomous communities in Spain. ⢠Recent publications from the nirsevimab clinical trials have evidenced a high RSV protective effect, but data on its effect on real life patients who require pediatric intensive care unit admission are missing.
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Hospitalización , Programas de Inmunización , Unidades de Cuidado Intensivo Pediátrico , Infecciones por Virus Sincitial Respiratorio , Humanos , Lactante , Masculino , Femenino , Estudios Prospectivos , Unidades de Cuidado Intensivo Pediátrico/estadística & datos numéricos , Infecciones por Virus Sincitial Respiratorio/prevención & control , Hospitalización/estadística & datos numéricos , España , Anticuerpos Monoclonales Humanizados/uso terapéutico , Bronquiolitis , Recién Nacido , Antivirales/uso terapéutico , Bronquiolitis ViralRESUMEN
We investigated the uptake of nirsevimab for infants and the bivalent respiratory syncytial virus prefusion F (RSVPreF) vaccine for pregnant persons as measures for RSV prevention during an infant's birth hospitalization in a military treatment facility. We found >85% uptake between October 2023 to February 2024. These data may aid health systems plan for future RSV seasons.
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Respiratory syncytial virus (RSV) represents a high burden of disease in children and the primary cause of hospitalization, especially in children under 1 year old. In the Valencian Community (Spain), nirsevimab, a long-acting monoclonal antibody, was introduced for the RSV 2023-2024 season as a universal pre-exposure prophylaxis for high-risk children and those under 6 months old. This study examines its impact, coverage, and effectiveness. The campaign achieved 88.5 % coverage and 73.7 % of effectiveness. Analysis of over 27,000 susceptible children (over 24,000 immunized), showed that those immunized exhibited a threefold reduction in RSV incidence compared to non-immunized ones. To prevent one case, the number needed to immunize (NNI) was 63. Hospitalizations due to acute respiratory infections were almost two times lower in immunized children compared to non-immunized ones (0.9 % vs 1.6 %, respectively). These first results showcase the preliminary positive impact of this public health intervention.