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Post-licensure safety of nirsevimab from the Canadian National Vaccine Safety (CANVAS) network [PDF]

Human Vaccines & Immunotherapeutics
Although clinical trials have shown that nirsevimab is safe, post-licensure safety data from routine clinical settings are lacking. This study describes parent-reported health events occurring within seven days of nirsevimab administration.
Marina Viñeta Paramo, Marilou Kiely, Louis Valiquette, Matthew P. Muller, Allison McGeer, Jennifer E. Isenor, Manish Sadarangani, James D. Kellner, Otto G. Vanderkooi, Kimberly Marty, Pascal M. Lavoie, Julie A. Bettinger   +11 more
doaj   +2 more sources

Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants

New England Journal of Medicine, 2023
The safety of the monoclonal antibody nirsevimab and the effect of nirsevimab on hospitalizations for respiratory syncytial virus (RSV)-associated lower respiratory tract infection when administered in healthy infants are unclear.In a pragmatic trial, we randomly assigned, in a 1:1 ratio, infants who were 12 months of age or younger, had been born at a
Simon B Drysdale, Katrina Cathie, Pierre Tissières   +2 more
exaly   +6 more sources

Real-world impact of nirsevimab on RSV hospitalizations in children under 2 years of age: retrospective monocentric study in a large German tertiary pedatric center [PDF]

Molecular and Cellular Pediatrics
Background Respiratory syncytial virus (RSV) infection is a leading cause of hospitalization among infants and young children. Broad immunization with the monoclonal antibody nirsevimab represents a promising preventive strategy. However, real-world data
Moritz Bauer, Anke Wendt, Marcus A. Mall, Horst von Bernuth, Stephanie Thee   +4 more
doaj   +2 more sources

Cost-Effectiveness Analysis of Clesrovimab for Respiratory Syncytial Virus in Infants in the United States [PDF]

Vaccines
Background/Objectives: Respiratory syncytial virus (RSV) causes a significant hospitalization burden in infants. The objective of this study was to evaluate the cost-effectiveness of introducing clesrovimab, a recently approved long-acting monoclonal ...
Klodeta Kura, John C. Lang, Dawei Wang, Yoonyoung Choi, Michelle G. Goveia, Anushua Sinha, Yao-Hsuan Chen, Elamin H. Elbasha   +7 more
doaj   +2 more sources

Cost-Effectiveness of Alternative Immunization Strategies to Protect Infants Against Respiratory Syncytial Virus in Germany: A Decision Modeling Study [PDF]

Infectious Diseases and Therapy
Introduction Germany’s Standing Committee on Vaccination (STIKO) recommends the use of monoclonal antibody nirsevimab for infants in their first respiratory syncytial virus (RSV) season; however, incorporating RSVpreF maternal vaccination may protect ...
Caroline Lade, Erin Quinn, Lea J. Bayer, Amy W. Law, Christof von Eiff, Julia Schiffner-Rohe, Mark Atwood, Bennet Huebbe, Ahuva Averin   +8 more
doaj   +2 more sources

Cost-Effectiveness of Nirsevimab and Clesrovimab in Preventing Respiratory Syncytial Virus Lower Respiratory Tract Disease in Infants in the United States: A Modeling Study [PDF]

Infectious Diseases and Therapy
Introduction Respiratory syncytial virus (RSV) is the leading cause of infant hospitalizations in the United States, with a significant seasonal impact on healthcare resources. Long-acting monoclonal antibodies (mAbs), nirsevimab and clesrovimab, provide
Benjamin Yarnoff, Matthieu Beuvelet, Samira Soudani, Maureen P. Neary, Erin N. Hodges, Ayman Chit, Maribel Tribaldos, Veronica Gabriel, Robert Musci, Jeroen Geurtsen, Leonard R. Krilov   +10 more
doaj   +2 more sources

Comprehensive Summary of Safety Data on Nirsevimab in Infants and Children from All Pivotal Randomized Clinical Trials

Pathogens
Background: Nirsevimab is approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season and in children aged ≤24 months who remain vulnerable to severe RSV
Vaishali S Mankad, Amanda Leach, Yue Chang   +2 more
exaly   +3 more sources

Impact of Seasonal Nirsevimab Administration in Infants Born During the RSV Circulation Period on RSV-Related Hospitalizations: A Population-Based Study from Emilia-Romagna, Northern Italy [PDF]

Vaccines
Background: Respiratory syncytial virus (RSV) is a leading cause of hospitalization in early infancy, with the greatest burden occurring in the first months of life. Following the COVID-19 pandemic, many countries experienced intensified RSV circulation.
Susanna Esposito, Matteo Puntoni, Giuseppe Maglietta, Alessandro De Fanti, Chiara Ghizzi, Giacomo Biasucci, Federico Marchetti, Melodie Olivia Aricò, Gianluca Vergine, Marcello Stella, Battista Guidi, Agnese Suppiej, Francesca Alberghi, Emanuele Filice, Maria Elena Capra, Enrico Valletta, Andrea Miceli, Cristina Malaventura, Beatrice Rita Campana, Valentina Fainardi, Caterina Caminiti   +20 more
doaj   +2 more sources

Evaluating the Effectiveness of Nirsevimab in Reducing Pediatric RSV Hospitalizations in Spain

Vaccines
Background/Objectives: Respiratory syncytial virus (RSV) is a major cause of hospitalization in infants. Nirsevimab has demonstrated to be a promising tool for preventing severe RSV disease.
Sara Jimeno Ruiz, Adrian Peláez, Silvina Natalini Martinez   +2 more
exaly   +3 more sources

Systematic Review: Efficacy, Safety Profile, and Cost-Effectiveness of Nirsevimab Versus Palivizumab for RSV Prevention in Children Under 24 Months [PDF]

Children
Background: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infections (LRTI) in infants and young children, with significant morbidity, hospitalizations, and healthcare costs.
Andreea Văduva, Alexandru Dinulescu, Anca Cristina Drăgănescu, Sorin Claudiu Man, Doina Anca Pleșca   +4 more
doaj   +2 more sources