Comment by the Advisory Committee on Vaccines of the Spanish Association of Paediatrics on Evidences in Paediatrics about nirsevimab

Bronchiolitis continues to be a major health problem in Spain, as it generates thousands of consultations in primary care every year, a backlog in paediatric hospitalisation and intensive care wards, and millions in costs to the National Health System. Most of those who require hospital admission are healthy infants, without any known risk factor. The very high incidence of the disease and the absence of a specific treatment means that paediatricians are impassive in the face of this annual epidemic, unable to offer our patients either a preventive or therapeutic option. In November 2022, the European Medicines Agency granted marketing authorisation for a monoclonal antibody specific against respiratory syncytial virus (RSV) F protein, following results from initial trials in more than 3,000 infants that demonstrated greater than 75% efficacy in preventing RSV hospitalisations. Preliminary results from the HARMONIE study, conducted in over 8000 individuals, were reported in May 2023, representing the first real-life experience with the use of nirsevimab and showing greater than 80% efficacy in preventing hospitalisations for bronchiolitis. This text presents the arguments of the Vaccine Advisory Committee of the Spanish Association of Paediatrics to support the recommendation made by this group for its routine use in newborns and infants under 6 months of age in Spain.