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Effectiveness of Nirsevimab on Primary Care Visits for Respiratory Syncytial Virus-Associated Acute Otitis Media in

Lea Lenglart1, Corinne Levy2, Christophe Batard3

  • 1Pediatric Emergency Department, Robert Debré Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France; IAME (Infection, Antimicrobials, Modelling, Evolution), INSERM UMR 1137, Paris Cité University, Paris, France.

The Journal of Pediatrics
|March 20, 2026
PubMed

Insights

Nirsevimab significantly reduced respiratory syncytial virus (RSV)-associated acute otitis media (AOM) in infants. This passive immunization demonstrated 78.2% effectiveness, highlighting its broader protective benefits against respiratory infections.

Area of Science:

  • Pediatrics
  • Infectious Diseases
  • Immunology

Background:

  • Respiratory syncytial virus (RSV) is a common cause of respiratory tract infections in infants.
  • Acute otitis media (AOM) is a frequent complication of RSV infections.
  • Nirsevimab is a monoclonal antibody providing passive immunization against RSV.

Purpose of the Study:

  • To estimate the effectiveness of nirsevimab in preventing RSV-associated AOM in ambulatory care settings.
  • To evaluate the impact of nirsevimab on AOM incidence during RSV seasons.

Main Methods:

  • A test-negative design study was conducted using data from the prospective OURSYN study in France (2020-2025).
  • Nasopharyngeal samples were collected from infants under one year with AOM during two RSV seasons following nirsevimab introduction.
  • Multivariable logistic regression analysis was performed to adjust for various infant and demographic factors.

Main Results:

  • A total of 236 AOM events were analyzed, with RSV detected in 29.1% and 15.8% of cases during the first and second seasons, respectively.
  • Nirsevimab demonstrated an adjusted effectiveness of 78.2% (95% CI 44.4-92.4) in preventing RSV-AOM.
  • Sensitivity analyses confirmed these findings.

Conclusions:

  • Nirsevimab is effective in preventing RSV-associated AOM in infants.
  • These results suggest nirsevimab offers broader protection against complications of respiratory tract infections.
Abstract

Keywords:
RSVacute otitis medianirsevimabprimary care

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