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Recommendation for use of a long-acting monoclonal antibody to prevent respiratory syncytial virus infection in infants and young children.
Clin Exp Pediatr
September 2025
Department of Pediatrics, Korea University College of Medicine, Seoul, Korea.
Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory tract infections (LRTIs) in infants and young children. In April 2024, the Korea Ministry of Food and Drug Safety approved nirsevimab (Beyfortus), a long-acting monoclonal antibody, as a passive immunization to prevent RSV-associated LRTI among infants and young children. Nirsevimab was launched in Korea in February 2025.
View Article and Find Full Text PDFBefore the introduction of universal respiratory syncytial virus (RSV) immunization recommendations for infants, RSV was the leading cause of hospitalization among infants in the United States. Since 2023, CDC's Advisory Committee on Immunization Practices (ACIP) has recommended that all infants be protected against RSV-associated lower respiratory tract infection (LRTI) through either 1) maternal RSV vaccination during pregnancy (Abrysvo, Pfizer) or 2) administration of nirsevimab (Beyfortus, Sanofi and AstraZeneca), a long-acting RSV monoclonal antibody, to the infant. In June 2025, the Food and Drug Administration licensed clesrovimab (Enflonsia, Merck), a second long-acting RSV monoclonal antibody, for prevention of RSV-associated LRTI in infants.
View Article and Find Full Text PDFAnalysis of the economically justifiable price of nirsevimab to prevent respiratory syncytial virus infection in Korea.
Hum Vaccin Immunother
December 2025
Department of Regulatory Science, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
The current standard-of-care prophylaxis for respiratory syncytial virus (RSV) is primarily administered to high-risk infant populations. We conducted a cost-effectiveness analysis to determine the economically justifiable price of nirsevimab compared with the standard of care in preventing medically attended RSV-associated lower respiratory tract infections from all infants and palivizumab-eligible children <2 years in South Korea. A month-age-specific static decision-tree model was used from a societal perspective, with a primary time horizon of one RSV season and an extended time horizon of three years.
View Article and Find Full Text PDFEfficacy and Safety of Anti-Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab in Neonates: A Real-World Monocentric Study.
Vaccines (Basel)
August 2025
Department of Medicine, Surgery, and Dentistry, University of Salerno, 84081 Baronissi, Italy.
Background: RSV remains a leading cause of infant hospitalization worldwide, and the recently approved nirsevimab could represent an effective and safe prophylactic strategy to prevent severe infections in the general neonatal population.
Objectives: We conducted a retrospective observational monocentric pilot study in a mixed preterm/term birth cohort to add real-world evidence of the efficacy and safety of nirsevimab in preventing severe RSV infection.
Methods: We included a total of 2035 consecutive infants admitted to the Neonatal Unit, University Hospital "San Giovanni di Dio e Ruggi d'Aragona", Salerno, Italy, from November 2024 to April 2025.
The Number Needed to Immunize (NNI) to Assess the Benefit of a Prophylaxis Intervention with Monoclonal Antibodies Against RSV.
Vaccines (Basel)
July 2025
Dipartimento di Scienze della Salute, Università degli Studi di Firenze, 50134 Firenze, Italy.
Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections in infants and children, as well as hospitalizations for respiratory infections in the pediatric population, representing a significant public health concern. Nirsevimab, a long-acting anti-RSV monoclonal antibody, has recently been approved by the European Medicines Agency (EMA). The aim of this study is to assess the utility of certain parameters, such as the Number Needed to Immunize (NNI), in supporting decision-makers regarding the introduction of nirsevimab as a universal prophylactic measure.
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