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Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants in France

Assistance Publique - Hôpitaux de Paris · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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respiratory-syncytial-virusvaccine
Bronchiolitis is a viral lower respiratory tract infection, caused in 50 to 80% of cases by the respiratory syncytial virus (RSV). Although generally mild, RSV bronchiolitis remains the leading cause of infant hospitalizations for acute respiratory distress in Europe. In France, nearly 30% of children under two years of age are affected annually, representing approximately 480,000 cases. RSV bronchiolitis accounts for 2 to 3% of hospital admissions among infants under one year each winter. These situations place a significant burden on pediatric intensive care units and emergency departments, impacting the delivery of care for other pediatric patients and raising concerns among parent and families. Until September 2023, RSV lower respiratory tract infection prevention strategies in infants in France were limited to non-pharmacological barrier measures, with a monthly injection of the monoclonal antibody palivizumab (Synagis®) recommended among high-risk infants, particularly those born preterm before 35 weeks of gestation. At the end of 2023, a new monoclonal antibody, nirsevimab (Beyfortus®), indicated for passive immunization in the general infant population, received marketing authorization. Administered as a single dose to neonates (from birth) and infants during their first RSV season, nirsevimab demonstrated an estimated efficacy of 76% to 83% in preventing severe RSV bronchiolitis during the 2023-2024 epidemic in France. At the same time, the RSV vaccine Abrysvo® (Pfizer) became available in France since September 2024, following European marketing authorization in August 2023. Administered during the third trimester of pregnancy, this maternal immunization strategy aims to confer passive immunity to neonates (from birth up to six months of age) through transplacental transfer of RSV-specific maternal antibodies. For the 2024-2025 RSV season, the national prevention strategy for RSV-related respiratory infections in infants is based on general non-pharmac
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