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Effect of Nirsevimab as a Primary Preventive Strategy on the Incidence, Severity, and Viral Etiology of
Santiago Presti1, Giuseppe Fabio Parisi1, Monica Tosto1
1Pediatric Pulmonology and Cystic Fibrosis Unit, AOU Policlinico "G. Rodolico-San Marco", University of Catania, Catania, Italy.
Insights
Nirsevimab significantly reduced infant hospitalizations for bronchiolitis by 84% in Sicily. This long-acting antibody also decreased respiratory syncytial virus (RSV) and other viral cases, proving effective in preventing severe illness.
Area of Science:
- Pediatric infectious diseases
- Immunology
- Public health
Background:
- Bronchiolitis is a common infant respiratory illness, frequently caused by RSV, and a leading cause of hospitalization for infants under one year.
- Nirsevimab, a long-acting monoclonal antibody, was approved in 2022 to mitigate RSV-related hospitalizations and severe outcomes.
- This study evaluates Nirsevimab's effect on bronchiolitis incidence, severity, and viral causes in Sicily between 2021 and 2025.
Purpose of the Study:
- To assess the impact of Nirsevimab on the incidence and severity of infant bronchiolitis.
- To analyze changes in viral etiology, including RSV and non-RSV infections, following Nirsevimab implementation.
- To evaluate the duration of hospital stays and respiratory support needs in hospitalized infants.
Main Methods:
- An observational study was conducted involving pediatric patients hospitalized with bronchiolitis from October 2021 to March 2025.
- Data collected included viral etiology, length of hospital stay, clinical severity, and respiratory support requirements.
- Statistical analyses compared outcomes across four epidemic seasons, focusing on the 2024-2025 season with Nirsevimab immunization.
Main Results:
- Hospitalized bronchiolitis incidence decreased by 84% in the 2024-2025 season compared to prior years (p < 0.0001).
- A significant reduction in both RSV and non-RSV viral cases was observed in the 2024-2025 season.
- Average hospital stay duration and clinical severity remained consistent, with only one Nirsevimab-treated patient hospitalized and experiencing mild symptoms.
Conclusions:
- Nirsevimab introduction in Sicily led to a substantial decrease in overall bronchiolitis incidence.
- The antibody effectively reduced both RSV and non-RSV infections contributing to bronchiolitis.
- Findings confirm Nirsevimab's efficacy in preventing severe bronchiolitis cases that necessitate hospitalization.
Background:
Bronchiolitis is a prevalent viral respiratory illness in infants, often caused by respiratory syncytial virus (RSV). It is the leading cause of hospitalization in children under 1 year of age. The introduction of Nirsevimab, a long-acting monoclonal antibody approved in 2022, aimed to reduce RSV-related hospitalizations and severe cases. This study assesses the impact of Nirsevimab on bronchiolitis incidence, severity, and viral etiology in Sicily from 2021 to 2025.
Methods:
This observational study included all pediatric patients hospitalized for bronchiolitis at the University of Catania's Pediatric Respiratory Unit between October 2021 and March 2025. Data were collected on viral etiology, hospital stay duration, clinical severity and respiratory support requirements across four epidemic seasons. Statistical analysis was used to compare outcomes across the different years, with a focus on the 2024-2025 season, which was the first to implement Nirsevimab immunization.
Results:
From 2022 to 2025, the incidence of hospitalized bronchiolitis decreased significantly, with a reduction of 84% in the 2024-2025 season compared to previous (2021-22, 2022-23, 2023-24) years (p < 0.0001). In the 2024-2025 season, a significant difference was observed in the percentage of RSV cases in 2025 compared to previous years and a significant reduction in the circulation of non-RSV viruses. The average hospital stay and clinical severity remained stable throughout the years. Only one hospitalized patient in the 2024-2025 season had received Nirsevimab, presenting with mild bronchiolitis.
Conclusion:
The introduction of Nirsevimab in Sicily led to a significant reduction in bronchiolitis incidence, with a reduction of RSV and non-RSV cases. Clinical severity and hospital stay duration remained unchanged. The findings support the efficacy of Nirsevimab in preventing severe bronchiolitis requiring hospitalization.
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