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Nirsevimab immunization’s real-world effectiveness in preventing severe bronchiolitis: a test-negative case-control study
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  • Marta Agüera,
  • Aleix Soler-Garcia,
  • Carme Alejandre,
  • Sara Moussalam-Merino,
  • Pere Sala Castellví,
  • Gemma Pons,
  • Daniel Penela-Sánchez,
  • Carla González-Grado,
  • Carme Climent,
  • Judit Alsina-Rossell,
  • Cristina Esteva,
  • Clàudia Fortuny,
  • Mariona-F de-Sevilla,
  • Juan-José García-García,
  • Pedro Brotons,
  • Albert Balaguer,
  • Josep Estrada,
  • Iolanda Jordan,
  • Carmen Muñoz-Almagro,
  • Cristian Launes
Marta Agüera
Hospital Sant Joan de Déu
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Aleix Soler-Garcia
Hospital Sant Joan de Déu
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Carme Alejandre
Hospital Sant Joan de Déu
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Sara Moussalam-Merino
Hospital Sant Joan de Déu
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Pere Sala Castellví
Universitat Internacional de Catalunya Facultat de Medicina i Ciencies de la Salut
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Gemma Pons
Hospital Sant Joan de Déu
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Daniel Penela-Sánchez
Institut de Recerca Sant Joan de Déu
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Carla González-Grado
Hospital Sant Joan de Déu
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Carme Climent
Universitat Internacional de Catalunya Facultat de Medicina i Ciencies de la Salut
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Judit Alsina-Rossell
Hospital Sant Joan de Déu
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Cristina Esteva
Institut de Recerca Sant Joan de Déu
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Clàudia Fortuny
Hospital Sant Joan de Déu
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Mariona-F de-Sevilla
Hospital Sant Joan de Déu
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Juan-José García-García
Hospital Sant Joan de Déu
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Pedro Brotons
Institut de Recerca Sant Joan de Déu
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Albert Balaguer
Universitat Internacional de Catalunya Facultat de Medicina i Ciencies de la Salut
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Josep Estrada
Hospital Nostra Senyora de Meritxell
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Iolanda Jordan
Universitat de Barcelona Departament de Cirurgia i Especialitats Medicoquirurgiques
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Carmen Muñoz-Almagro
Institut de Recerca Sant Joan de Déu
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Cristian Launes
Hospital Sant Joan de Déu

Corresponding Author:claunes@ub.edu

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Abstract

Background Several clinical trials have shown that nirsevimab, an antibody targeting the respiratory syncytial virus (RSV), reduces RSV-bronchiolitis requiring admission. In 2023-2024, Catalonia and Andorra adopted immunization strategies for children < 6 months and those born during the epidemic season. This study evaluates the effectiveness of nirsevimab in preventing hospitalizations from RSV bronchiolitis. Methods In the epidemic season of 2023-2024, a test-negative case-control study was conducted in three hospitals from Catalonia and Andorra. Patients <12 months old admitted with bronchiolitis and tested for RSV using molecular microbiology tests were included. The effectiveness in preventing RSV-bronchiolitis hospitalization and severe disease was estimated using multivariate models. Comparisons between immunized, non-immunized and non-eligible patients were made in prospectively collected epidemiological, clinical, and microbiological variables. Results 234 patients were included. RSV was detected in 141/234(60.2%), being less common in the immunized group (37% vs 75%, p<0.001). The rate of immunized patients among those eligible was 59.7%. The estimated effectiveness for RSV-associated lower respiratory tract infection was 81.0% (95% confidence interval: 60.9-90.7), and for preventing severe disease (the need for NIV/CMV), 85.6% (41.7-96.4%). No significant differences by immunization status were observed in patients with RSV concerning viral co-infections, the need for NIV/CMV or length of hospital stay. Conclusions This study provides real-world evidence of the effectiveness of nirsevimab in preventing RSV-LRTI hospitalization and severe disease in infants during their first RSV season following a systematic immunization program. Immunized patients did not exhibit a higher rate of viral co-infections nor differences in clinical severity once admitted.
20 Apr 2024Submitted to Pediatric Allergy and Immunology
21 Apr 2024Submission Checks Completed
21 Apr 2024Assigned to Editor
23 Apr 2024Reviewer(s) Assigned
02 Jun 2024Submission Checks Completed
02 Jun 2024Assigned to Editor
02 Jun 2024Review(s) Completed, Editorial Evaluation Pending
Jun 2024Published in Pediatric Allergy and Immunology volume 35 issue 6. https://doi.org/10.1111/pai.14175