Abstract
Introduction: Respiratory syncytial virus (RSV) represents a major cause of pediatric hospitalizations. Nirsevimab, a monoclonal antibody administered as a single dose, has demonstrated significant efficacy in preventing lower respiratory tract infections associated with RSV. Evidence from clinical trials and national programs, particularly in Spain and France, indicates reductions of up to 70% in hospitalizations and protection against severe outcomes. These findings suggest that including nirsevimab in childhood immunization strategies may relieve hospital pressure and provide substantial health benefits for infants.Objectives: To evaluate the effectiveness of nirsevimab in preventing hospitalizations and severe admissions due to RSV in infants and newborns.Methodology: This is a narrative literature review encompassing studies from January 2018 to December 2025 on nirsevimab in infants and children under two years old. Searches were conducted in PubMed/MEDLINE, Embase, Scopus, Web of Science, Cochrane Library, and Google Scholar using English descriptors combined with Boolean operators. Included studies comprised clinical trials and observational studies reporting relevant efficacy and safety outcomes, published in English, Spanish, French, or Portuguese. Population, methodological, and clinical data were systematically extracted and narratively analyzed.Results and Discussion: Recent studies demonstrate that nirsevimab provides substantial protection against RSV-related hospitalizations in infants, with a relative risk reduction exceeding 85%, both in clinical trials and real-world settings. Meta-analyses confirm significant reductions in hospitalizations and ICU admissions, particularly in children up to 12 months, without altering the average length of stay. The Spanish experience shows overall effectiveness above 70%, reaching over 87% for hospitalizations and 90% for ICU admissions, reinforcing its public health impact and role in alleviating healthcare system burden.Conclusion: Nirsevimab represents a significant advancement in preventing RSV-related hospitalizations in infants, with consistent efficacy and favorable safety, although gaps remain regarding the duration of protection and socioeconomic impact.
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Copyright (c) 2025 Luiz Gustavo Rezende de Barros, Pedro Lucas Borges Souza, Yanna de Fátima Pereira Borges Costa, Maryanna Alves Correia , Thalisson Araújo Nunes , Mateus Modolo da Costa, Vitor Hugo Leonel e Silva , Jordana Magda da Silva e Castro, Maria Eduarda Silva Teixeira , Maria Clara Peres de Castelo Branco , Amanda Pereira Alves, Kelly Cristiene de Freitas Borges