Impact of Seasonal Nirsevimab Administration in Infants Born During the RSV Circulation Period on RSV-Related Hospitalizations: A Population-Based Study from Emilia-Romagna, Northern Italy
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Published on: April 14, 2012
Susanna Esposito1,2, Matteo Puntoni3, Giuseppe Maglietta3
1Pediatric Clinic, University-Hospital of Parma, 43126 Parma, Italy.
Insights
Seasonal nirsevimab significantly reduced respiratory syncytial virus (RSV) hospitalizations in young infants. This long-acting antibody provides season-long protection, lowering infant hospital admission rates effectively.
Area of Science:
- Pediatrics
- Infectious Diseases
- Public Health
Background:
- Respiratory syncytial virus (RSV) is a major cause of infant hospitalization, particularly in the first months of life.
- Intensified RSV circulation observed globally post-COVID-19 pandemic.
- Nirsevimab, a long-acting monoclonal antibody, offers season-long protection against RSV after a single dose.
Purpose of the Study:
- To evaluate the population-level impact of seasonal nirsevimab administration on RSV-related hospitalizations in young infants in Italy.
- To assess the effectiveness of nirsevimab for infants born during the RSV circulation period.
Main Methods:
- Population-based observational study using regional hospital discharge records (Emilia-Romagna, Italy, Jan 2017-Apr 2025).
- Analysis focused on RSV seasons (Oct-Mar) and infants ≤180 days old, identifying RSV hospitalizations via ICD-9-CM codes.
- Incidence rate ratios (IRRs) compared hospitalization rates in the post-nirsevimab season (2024-2025) with pre-nirsevimab (2023-2024) and pre-COVID (2018-2019) seasons.
Main Results:
- A substantial reduction in RSV hospitalizations was observed in the post-nirsevimab season (252 cases) compared to pre-nirsevimab (753 cases) and pre-COVID (551 cases) seasons.
- Nirsevimab use was associated with significantly lower hospitalization rates: IRR 0.36 vs. pre-nirsevimab season and IRR 0.52 vs. pre-COVID season.
- Reductions were consistent across epidemic months and most pronounced in infants aged 0-4 months.
Conclusions:
- Seasonal nirsevimab administration to infants during RSV circulation markedly reduced RSV-related hospitalizations in early infancy.
- Findings support the efficacy of targeted, seasonally timed infant immunoprophylaxis for population-level RSV prevention.
- Nirsevimab represents an effective strategy for mitigating the burden of RSV in vulnerable young infants.
Background:
Respiratory syncytial virus (RSV) is a leading cause of hospitalization in early infancy, with the greatest burden occurring in the first months of life. Following the COVID-19 pandemic, many countries experienced intensified RSV circulation. Nirsevimab, a long-acting monoclonal antibody providing season-long protection after a single dose, was introduced in Italy for the 2024-2025 RSV season and recommended for infants born during the period of RSV circulation. We evaluated the population-level impact of this seasonal nirsevimab strategy on RSV-related hospitalizations among young infants.
Methods:
We conducted a population-based observational study using regional hospital discharge records from Emilia-Romagna, Northern Italy, spanning January 2017 to April 2025. Analyses were restricted to RSV seasons (October-March) and infants aged ≤180 days. RSV-related hospitalizations were identified using ICD-9-CM codes. Hospitalization rates were calculated per 100,000 person-days. Incidence rate ratios (IRRs) were estimated using negative binomial regression models adjusted for season, age group, and sex, with clustering at the hospital level. The post-nirsevimab season (2024-2025) was compared with the immediate pre-nirsevimab season (2023-2024) and a pre-COVID reference season (2018-2019).
Results:
A total of 551 RSV hospitalizations occurred in the pre-COVID season, 753 in the pre-nirsevimab season, and 252 in the post-nirsevimab season. The post-nirsevimab season was associated with a substantial reduction in RSV-related hospitalization rates compared with both the pre-COVID season (IRR 0.52; 95% CI 0.41-0.66) and the pre-nirsevimab season (IRR 0.36; 95% CI 0.29-0.44). Reductions were observed consistently across epidemic months and were most pronounced during the first three to four months of life.
Conclusions:
Seasonal administration of nirsevimab to infants born during the RSV circulation period was associated with a marked and sustained reduction in RSV-related hospitalizations in early infancy. These findings support the effectiveness of targeted, seasonally timed infant immunoprophylaxis as a population-level RSV prevention strategy.
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