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Nirsevimab Effectiveness Against RSV-Related Hospitalisations in Children Under 24 Months: A Test-Negative
Vânia Gaio1,2, Camila Henriques3, Miguel Lança3,4
1Department of Epidemiology, National Institute of Health Doutor Ricardo Jorge, Lisbon, Portugal.
Influenza and Other Respiratory Viruses
|December 1, 2025
Summary
Nirsevimab effectively reduced hospitalizations from respiratory syncytial virus (RSV) by 78.5% in infants under two years old. This study supports Nirsevimab
Area of Science:
- Pediatrics
- Immunology
- Public Health
Background:
- Respiratory syncytial virus (RSV) is a leading cause of infant hospitalizations.
- Effective immunization strategies are crucial for preventing severe RSV disease in vulnerable populations.
Purpose of the Study:
- To evaluate the real-world effectiveness of Nirsevimab in preventing RSV-related hospitalizations in infants.
- To provide evidence supporting public health decisions regarding RSV immunisation.
Main Methods:
- A test-negative case-control design was employed within the VigiRSV network.
- Data were collected from eligible children under two years of age between weeks 43/2024 and 16/2025.
- 341 participants were included, with 137 testing positive for RSV.
Main Results:
- Adjusted Nirsevimab effectiveness (NE) against RSV-related hospitalization was 78.5% (95% CI: 59.3-89.0).
- The study population consisted primarily of healthy infants (91.2% without chronic conditions).
- Sensitivity analyses confirmed the robustness of the findings.
Conclusions:
- Nirsevimab demonstrates significant effectiveness in preventing RSV-related hospitalizations in a predominantly healthy infant population.
- These findings support the use of Nirsevimab for RSV immunisation programs.
- The study contributes valuable data for informing public health strategies against RSV.
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