Dataset Information

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.

ABSTRACT: 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.

SUBMITTER: Lopez-Lacort M

PROVIDER: S-EPMC10853977 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature

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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.

López-Lacort Mónica M Muñoz-Quiles Cintia C Mira-Iglesias Ainara A López-Labrador F Xavier FX Mengual-Chuliá Beatriz B Fernández-García Carlos C Carballido-Fernández Mario M Pineda-Caplliure Ana A Mollar-Maseres Juan J Shalabi Benavent Maruan M Sanz-Herrero Francisco F Zornoza-Moreno Matilde M Pérez-Martín Jaime Jesús JJ Alfayate-Miguelez Santiago S Pérez Crespo Rocío R Bastida Sánchez Encarnación E Menasalvas-Ruiz Ana Isabel AI Téllez-González Mª Cinta MC Esquiva Soto Samuel S Del Toro Saravia Carlos C Sanz-Muñoz Iván I Eiros José María JM Matías Del Pozo Vanesa V Toquero-Asensi Marina M Pastor-Villalba Eliseo E Lluch-Rodrigo José Antonio JA Díez-Domingo Javier J Orrico-Sánchez Alejandro A

Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin 20240201 6

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 ...[more]

PMID: 38333937

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Project description:Respiratory syncytial virus (RSV) causes most of the cases of bronchiolitis and thousands of deaths annually, particularly in infants less than 6 months old. In Catalonia (Spain), infants born between April 2023 and March 2024 aged 0-6 months during their first RSV season have been candidates to receive nirsevimab, the novel monoclonal antibody against RSV, since October 2023. We aimed to analyse the dynamics of all-causes bronchiolitis diagnoses and RSV community infections in the current season and compare them to pre-nirsevimab epidemics. We collected epidemiological data from the Information System for Surveillance of Infections in Catalonia (SIVIC) on daily all-causes bronchiolitis clinical diagnoses and RSV-confirmed cases provided by rapid antigen tests in primary care practices. We calculated the rate ratio (RR) for the incidence of all-causes bronchiolitis for children aged 0-11 m-old with respect to 12-35 m-old between September 2014 and January 2024. We analysed the RR of the incidence of RSV-confirmed infection for 0-11 m-old and 12-35 m-old with respect to the > 35 m-old, from January 2021 to January 2024. We then computed the relative difference of the RR, designated as percentage of reduction of risk, between season 2023/2024 and former epidemics. With a global coverage recorded rate for nirsevimab of 82.2% in January 2024, the age-specific 0-11 m-old RR (95% CI) of RSV infection incidence for > 35 m-old was 1.7 (1.5-2.0) in season 2023/2024. The RR (95% CI) had been 7.4 (5.6-9.9), 8.8 (6.9-11.3), and 7.1 (5.7-8.9) in 2020/2021, 2021/2022, and 2022/2023, respectively. Regarding the incidence of all-causes bronchiolitis for the 0-11 m-old group compared to the 12-35 m-old, the pre-pandemic (2014/2015-2019/2020) and 2022/2023 RR (95% CI) were 9.4 (9.2-9.6) and 6.0 (5.7-6.2), respectively, significantly higher than the RR of 3.6 (3.4-3.8) for the most recent season, 2023/2024. Conclusion: Concurring with the introduction of nirsevimab, the risk of RSV infection for infants aged 0-11 m-old compared to > 35 m-old has been reduced by 75.6% (73.4-77.5) in last season, and the risk for all-causes bronchiolitis for 12-35 m-old by 61.9% (60.9-62.9) from the pre-pandemic period and by 39.8% (39.3-40.2) from the 2022/2023 epidemic, despite high RSV community transmission, especially in older infants What is Known: • RSV is responsible for approximately 70% of bronchiolitis cases and causes severe disease, particularly in infants < 6 months of age. • Nirsevimab effectiveness against RSV-associated disease, particularly hospitalisations, was expected to be around 80%; other Spanish regions, such as Galicia and Valencia, and European countries including Luxembourg and Germany, have already reported good results in implementing nirsevimab to prevent RSV-associated hospitalisations and PICU stays. What is New: • We provide insight into the community incidence of RSV and all-causes bronchiolitis for season 2023/2024, when nirsevimab has been introduced to the Catalan population, using. primary healthcare data, which enabled us to assess the burden of RSV infections and bronchiolitis in the commonly seasonally saturated primary healthcare practices. • Our study reveals that the risk of all-causes bronchiolitis for infants aged 0-11 m-old compared to older infants was reduced by 40% compared to the previous season and 62% compared to pre-pandemic standards, and for RSV infection it was reduced by 76%.

Project description:ImportanceRespiratory syncytial virus (RSV) infection can cause severe illness in adults. However, there is considerable uncertainty in the burden of RSV-associated hospitalizations among adults prior to RSV vaccine introduction.ObjectiveTo describe the demographic characteristics of adults hospitalized with laboratory-confirmed RSV and to estimate annual rates and numbers of RSV-associated hospitalizations, intensive care unit (ICU) admissions, and in-hospital deaths.Design, setting, and participantsThis cross-sectional study used data from the RSV Hospitalization Surveillance Network (RSV-NET), a population-based surveillance platform that captures RSV-associated hospitalizations in 58 counties in 12 states, covering approximately 8% of the US population. The study period spanned 7 surveillance seasons from 2016-2017 through 2022-2023. Included cases from RSV-NET were nonpregnant hospitalized adults aged 18 years or older residing in the surveillance catchment area and with a positive RSV test result.ExposureLaboratory-confirmed RSV-associated hospitalization, defined as a positive RSV test result within 14 days before or during hospitalization.Main outcomes and measuresHospitalization rates per 100 000 adult population, stratified by age group. After adjusting for test sensitivity and undertesting for RSV in adults hospitalized with acute respiratory illnesses, rates were extrapolated to the US population to estimate annual numbers of RSV-associated hospitalizations. Clinical outcome data were used to estimate RSV-associated ICU admissions and in-hospital deaths.ResultsFrom the 2016 to 2017 through the 2022 to 2023 RSV seasons, there were 16 575 RSV-associated hospitalizations in adults (median [IQR] age, 70 [58-81] years; 9641 females [58.2%]). Excluding the 2020 to 2021 and the 2021 to 2022 seasons, when the COVID-19 pandemic affected RSV circulation, hospitalization rates ranged from 48.9 (95% CI, 33.4-91.5) per 100 000 adults in 2016 to 2017 to 76.2 (95% CI, 55.2-122.7) per 100 000 adults in 2017 to 2018. Rates were lowest among adults aged 18 to 49 years (8.6 [95% CI, 5.7-16.8] per 100 000 adults in 2016-2017 to 13.1 [95% CI, 11.0-16.1] per 100 000 adults in 2022-2023) and highest among adults 75 years or older (244.7 [95% CI, 207.9-297.3] per 100 000 adults in 2022-2023 to 411.4 [95% CI, 292.1-695.4] per 100 000 adults in 2017-2018). Annual hospitalization estimates ranged from 123 000 (95% CI, 84 000-230 000) in 2016 to 2017 to 193 000 (95% CI, 140 000-311 000) in 2017 to 2018. Annual ICU admission estimates ranged from 24 400 (95% CI, 16 700-44 800) to 34 900 (95% CI, 25 500-55 600) for the same seasons. Estimated annual in-hospital deaths ranged from 4680 (95% CI, 3570-6820) in 2018 to 2019 to 8620 (95% CI, 6220-14 090) in 2017 to 2018. Adults 75 years or older accounted for 45.6% (range, 43.1%-48.8%) of all RSV-associated hospitalizations, 38.6% (range, 36.7%-41.0%) of all ICU admissions, and 58.7% (range, 51.9%-67.1%) of all in-hospital deaths.Conclusions and relevanceIn this cross-sectional study of adults hospitalized with RSV before the 2023 introduction of RSV vaccines, RSV was associated with substantial burden of hospitalizations, ICU admissions, and in-hospital deaths in adults, with the highest rates occurring in adults 75 years or older. Increasing RSV vaccination of older adults has the potential to reduce associated hospitalizations and severe clinical outcomes.

Project description:ImportanceNirsevimab, a long-acting monoclonal antibody, demonstrated efficacy against respiratory syncytial virus (RSV)-associated lower respiratory tract infections (LRTI) in clinical trials. Postlicensure monitoring is essential to confirm these benefits in clinical settings.ObjectiveTo estimate the effectiveness of nirsevimab against medically attended RSV infections in infants and to assess how effectiveness varies by disease severity, dosage, and time since immunization.Design, setting, and participantsThis test-negative case-control study utilized inpatient, outpatient, and emergency department data from the Yale New Haven Health System. Nirsevimab-eligible infants who were tested for RSV using polymerase chain reaction between October 1, 2023, and May 9, 2024, were included. Infants with RSV-positive results were cases and infants with RSV-negative results were controls.ExposureNirsevimab immunization, verified through state immunization registries.Main outcomes and measuresEffectiveness was estimated using multivariable logistic regression, adjusting for age, calendar month, and potential confounders. Separate models examined estimated effectiveness by clinical setting, dosage, time since immunization, and severity (defined as needing high-flow oxygen or intensive care unit admission). Broader outcomes were also analyzed, including all-cause LRTI and all-cause LRTI-associated hospitalization.ResultsThe analytic sample included 3090 infants (1722 male [57.3%]; median [IQR] age at testing, 6.7 [3.6-9.7] months), with 680 (22.0%) RSV-positive cases and 2410 (78.0%) RSV-negative controls. Nirsevimab uptake was 10.7% (330 patients), with 21 RSV-positive cases and 309 RSV-negative controls immunized. Adjusted effectiveness was 68.4% (95% CI, 50.3%-80.8%) against medically attended RSV infection, 61.6% (95% CI, 35.6%-78.6%) against outpatient visits, and 80.5% (95% CI, 52.0%-93.5%) against hospitalizations. The highest estimated effectiveness (84.6%; 95% CI, 58.7%-95.6%) was observed against severe RSV disease. Although estimated effectiveness against RSV infections declined from 79.3% (95% CI, 63.4%-90.6%) at 2 weeks postimmunization to 54.8% (95% CI, 16.3%-74.7%) at 14 weeks postimmunization, it remained significant. Estimated effectiveness did not vary substantially by dosage. During peak RSV season, nirsevimab appeared effective against all-cause LRTI (49.4%; 95% CI, 10.7%-72.9%) and all-cause LRTI-associated hospitalizations (79.1%; 95% CI, 27.6%-94.9%). From February to May 2024, when most LRTIs were caused by other viruses, its estimated effectiveness against these broader outcomes was negligible.Conclusions and relevanceIn this case-control study, nirsevimab provided substantial protection against RSV-associated outcomes. These findings support its continued use and provide evidence that may help boost public confidence in the immunization program.

Dataset Information

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.

Publications

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.

Similar Datasets

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