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Vaccinations01:51

Vaccinations

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Nirsevimab immunization's real-world effectiveness in preventing severe bronchiolitis: A test-negative case-control

Marta Agüera1, Aleix Soler-Garcia1,2,3, Carme Alejandre4

  • 1Pediatrics Department, Hospital Sant Joan de Déu, Barcelona, Spain.

Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology
|June 20, 2024
PubMed
Summary

Nirsevimab significantly reduced hospitalizations for respiratory syncytial virus (RSV) lower respiratory tract infections in infants. This real-world evidence supports nirsevimab

Keywords:
bronchiolitiseffectivenessimmunizationnirsevimabpediatricsseverity

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Area of Science:

  • Pediatric Infectious Diseases
  • Immunology
  • Public Health

Background:

  • Respiratory Syncytial Virus (RSV) bronchiolitis is a major cause of infant hospitalization.
  • Nirsevimab, an antibody targeting RSV, has shown promise in clinical trials.
  • Catalonia and Andorra implemented nirsevimab immunization strategies for infants in 2023-2024.

Purpose of the Study:

  • To evaluate the real-world effectiveness of nirsevimab in preventing RSV bronchiolitis hospitalizations.
  • To assess nirsevimab's impact on severe RSV disease in infants.
  • To compare outcomes between immunized and non-immunized infants.

Main Methods:

  • A test-negative case-control study was conducted across three hospitals.
  • Infants under 12 months admitted with bronchiolitis and tested for RSV were included.
  • Multivariate models estimated effectiveness against RSV hospitalization and severe disease.

Main Results:

  • Nirsevimab demonstrated 81.0% effectiveness against RSV-lower respiratory tract infection hospitalization.
  • Effectiveness in preventing severe disease (NIV/CMV) was 85.6%.
  • Immunized infants had significantly lower RSV detection rates (37% vs 75%).

Conclusions:

  • Nirsevimab provides real-world protection against RSV hospitalization and severe disease in infants.
  • The immunization program showed high effectiveness in a real-world setting.
  • No increased risk of viral coinfections or clinical severity was observed in immunized infants.