Safety and Efficacy of Nirsevimab in a Universal Prevention Program of Respiratory Syncytial Virus Bronchiolitis in Newborns and Infants in the First Year of Life in the Valle d'Aosta Region, Italy, in the 2023-2024 Epidemic Season.

Respiratory syncytial virus (RSV) bronchiolitis remains a significant global health burden, particularly in newborns and infants during their first year of life. The quest for an effective preventive strategy against RSV has long been sought, and recent developments have shown promise in the form of nirsevimab, a monoclonal antibody specifically designed for RSV prophylaxis. Valle d'Aosta was the first Italian region to propose universal prophylaxis with nirsevimab for newborns and infants in their first epidemic season as early as 2023-2024. This study describes the effectiveness and safety of the universal prevention program of RSV bronchiolitis using the monoclonal antibody nirsevimab in children resident in Valle d'Aosta born during the 2023-2024 epidemic season. There were 556 neonates born from 1 May 2023 to 15 February 2024. The risk of hospitalization for RSV bronchiolitis in 2023-2024 was 3.2%, compared to 7% in the 2022-2023 epidemic season ( < 0.001). After the start of the prophylaxis campaign with nirsevimab, the risk of hospitalization was 8.3% in the sample of infants who did not adhere to the prophylaxis, while no child in the sample of those treated ( < 0.001) was hospitalized for bronchiolitis. Few mild transient side effects were reported. This study shows the efficacy and safety of universal prophylaxis with nirsevimab in neonates, making Valle d'Aosta the first Italian region to offer universal prophylaxis to newborns without risk factors for RSV complications. Future research could further explore its long-term impact and cost-effectiveness.