[New therapies for old viruses: when everyone gets something wrong].

Abstract

The respiratory syncytial virus causes numerous respiratory infections in children, with particularly severe manifestations during the first months of life, especially in premature infants or those with pre-existing clinical conditions.In Italy, the introduction of nirsevimab, a monoclonal antibody that is more practical and potentially usable in a broader population compared to the previous palivizumab, has highlighted several critical issues in the management of the prevention system. Initially, the manufacturer proposed the drug under category C, making it fully paid by patients. Subsequently, the company began direct negotiations with regional authorities, which independently planned the administration of the drug at no cost to patients, adopting differing and inconsistent approaches to preventive immunoprophylaxis programmes.Difficulties worsened when a statement from the Italian Ministry of Health clarified that regions undergoing financial recovery plans could not guarantee the administration of nirsevimab, as the treatment was excluded from the essential levels of care. The public and media uproar surrounding this exclusion prompted institutions to find a rapid solution. A national agreement was reached, allocating funds for an immunization campaign covering approximately 75% of newborns, corresponding to the availability guaranteed by the manufacturer. Additionally, a solidarity distribution mechanism was introduced, allowing up to 20% of doses to be shared among regions to protect the most vulnerable individuals.Despite the campaign started with the onset of the epidemic season, challenges persist in organizing procurement processes and managing immunoprophylaxis operations, resulting in significant disparities in implementation across regions.The nirsevimab case underscores the urgency of a nationally coordinated and shared strategy among central institutions, regional authorities, and other stakeholders to ensure equity and effectiveness in prevention policies, especially in light of upcoming regional autonomies.