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Nirsevimab Effectiveness at Preventing RSV-Related Hospitalization in Infants
Marie Joelle Jabagi1, Jérémie Cohen2, Marion Bertrand1
1EPI-PHARE Scientific Interest Group in Epidemiology of Health Products, French National Agency for the Safety of Medicines and Health Products (ANSM), French National Fund for Health Insurance (CNAM), Saint-Denis, France.
NEJM Evidence
|February 25, 2025
Summary
Nirsevimab significantly reduced hospitalizations for respiratory syncytial virus lower respiratory tract infections (RSV-LRTIs) in infants. This real-world study confirms nirsevimab
Area of Science:
- Pediatric Infectious Diseases
- Immunology
- Public Health
Background:
- Pivotal trials indicated nirsevimab's efficacy against respiratory syncytial virus-associated lower respiratory tract infections (RSV-LRTIs).
- Real-world effectiveness data for nirsevimab in infant populations is crucial.
Purpose of the Study:
- To assess the real-world effectiveness of nirsevimab in preventing RSV-LRTI hospitalizations among infants.
- To evaluate nirsevimab's impact on RSV-LRTI requiring intensive care or respiratory support.
Main Methods:
- Population-based cohort study utilizing the French National Health Data System.
- Matched 1:1 cohort of nirsevimab-immunized infants and unimmunized controls.
- Propensity score-weighted conditional Cox models to estimate effectiveness for RSV-LRTI hospitalizations and related complications.
Main Results:
- Nirsevimab demonstrated 65% effectiveness in preventing RSV-LRTI hospitalizations (95% CI, 61-69).
- Significant effectiveness was observed for preventing RSV-LRTI requiring PICU (74%) or HDU (64%) admissions.
- Effectiveness was also noted for preventing RSV-LRTI hospitalizations requiring ventilation (66%) or oxygen therapy (67%).
Conclusions:
- A single nirsevimab injection provides substantial real-world protection against RSV-LRTI hospitalization in infants.
- Findings support the use of nirsevimab for broad infant protection against severe RSV disease.
