Multi-model assessment of the impact of newborn RSV immunisation on hospitalisation burden in the EU/EEA
Respiratory Syncytial Virus (RSV) is a major cause of respiratory infections across the EU/EEA, representing a recurrent source of pressure on healthcare systems. The burden of disease is particularly high in older adults, people with underlying comorbidities, and young children, resulting in increased demand for hospital care, especially for paediatric admissions. Depending on the country, RSV-related hospitalisations have been estimated to account for 7% to 52% of all paediatric respiratory hospitalisations, representing approximately 250 000 hospital admissions per year in the EU/EEA. Newborns have the highest per-capita rate of RSV-related hospitalisations, making immunisation strategies targeting infants in early life a central strategy to reduce hospital burden and ease healthcare demand.
RSV passive immunisation options for infants have been available since 1999, when palivizumab, a monoclonal antibody with a half-life of approximately 20 days, received authorisation from the European Commission (EC). Due to its short half-life, palivizumab requires up to five monthly injections throughout the RSV season and provides only seasonal protection. Its use has been restricted to at-risk infants, such as those born prematurely, with bronchopulmonary dysplasia, congenital heart disease, or severe immunodeficiency.
In October 2022, a new extended half-life monoclonal antibody, nirsevimab (Beyfortus, AstraZeneca/Sanofi), was authorised in the EU for children up to the age of 24 months. This product provides passive immunisation to protect neonates and infants who are vulnerable to severe RSV. In June 2026, the EC approved another monoclonal antibody, clesrovimab (Enflonsia, MSD) in newborns and infants during their first RSV season. In June 2023, a maternal RSV vaccine (Abrysvo, Pfizer) was also authorised in the EU. Vaccination of pregnant individuals between 24 and 36 weeks of gestation with this product has been shown to significantly reduce severe RSV-related respiratory infections in their infants during the first six months of life.
With the recent EU authorisation of the first RSV immunisation products intended for general population implementation, several EU/EEA countries have started or will soon begin the decision-making process on whether and how to introduce them into national programmes. Decisions on changing national immunisation programmes require consideration of multiple factors, such as the disease burden and epidemiology, the efficacy, effectiveness, cost-effectiveness and safety of new interventions, impact of the vaccine as estimated through transmission modelling and health economic/cost-effectiveness evaluations, ease of implementation, population acceptance, and national health priorities.
Multi-model assessment of the impact of newborn RSV immunisation on hospitalisation burden in the EU/EEA
English (979.8 KB - PDF)Supplementary material for ‘Multi-model assessment of the impact of newborn RSV immunisation on hospitalisation burden in the EU/EEA’
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