Nirsevimab in the New Era of RSV Prevention: Current Evidence, Emerging Challenges, and Future Perspectives.
- 1Neonatal Department, National and Kapodistrian University of Athens, Aretaieio Hospital, 11528 Athens, Greece.
- 2Department of Microbiology, Saint Savvas Oncology Hospital, 11522 Athens, Greece.
Abstract
Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infection (LRTI) and hospitalization in infants and young children worldwide, with the highest disease burden occurring in otherwise healthy term infants during the first 6 months of life. The recent introduction of long-acting monoclonal antibodies and maternal RSV vaccination has fundamentally changed preventive strategies against severe RSV disease. Evidence from randomized clinical trials and large real-world studies consistently demonstrates that a single dose of Nirsevimab provides season-long protection against RSV-associated LRTI and reduces hospitalization rate across diverse infant populations, while maintaining an excellent safety profile. Emerging data also support its effectiveness in routine clinical practice, although important uncertainties remain regarding long-term epidemiological effects, viral evolution, resistance, comparative effectiveness with maternal immunization, and optimal implementation across different healthcare settings. Current evidence supports Nirsevimab as a major advance in infant RSV prevention. However, continued surveillance, comparative effectiveness studies, and equitable global implementation will be essential to maximize its long-term public health impact. This narrative review summarizes current evidence on Nirsevimab, with emphasis on its clinical efficacy, safety, real-world effectiveness, resistance, implementation challenges, cost-effectiveness, and its role alongside maternal RSV vaccination.
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BibTeX
@article{vasou2026nirsevimab,
title = {{Nirsevimab in the New Era of RSV Prevention: Current Evidence, Emerging Challenges, and Future Perspectives.}},
author = {Marina Vasou and Rozeta Sokou and Georgios Kafalidis and Andreas G Tsantes and Rafaela Anna Moutsopoulou and Fotios Grigoropoulos and Eleni Katsianou and Nikoleta-Aikaterini Xixi and Elli-Panagiota Magklara and Konstantina Leontari and Zoi Iliodromiti and Theodora Boutsikou and Nicoletta Iacovidou},
journal = {Medicina (Kaunas, Lithuania)},
year = {2026},
month = sep,
doi = {10.3390/medicina62101858},
url = {https://europepmc.org/article/MED/42942389},
note = {CC BY},
}
RIS
TY - JOUR
TI - Nirsevimab in the New Era of RSV Prevention: Current Evidence, Emerging Challenges, and Future Perspectives.
AU - Marina Vasou
AU - Rozeta Sokou
AU - Georgios Kafalidis
AU - Andreas G Tsantes
AU - Rafaela Anna Moutsopoulou
AU - Fotios Grigoropoulos
AU - Eleni Katsianou
AU - Nikoleta-Aikaterini Xixi
AU - Elli-Panagiota Magklara
AU - Konstantina Leontari
AU - Zoi Iliodromiti
AU - Theodora Boutsikou
AU - Nicoletta Iacovidou
PY - 2026
DA - 2026/09/25
JO - Medicina (Kaunas, Lithuania)
DO - 10.3390/medicina62101858
UR - https://europepmc.org/article/MED/42942389
AB - Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infection (LRTI) and hospitalization in infants and young children worldwide, with the highest disease burden occurring in otherwise healthy term infants during the first 6 months of life. The recent introduction of long-acting monoclonal antibodies and maternal RSV vaccination has fundamentally changed preventive strategies against severe RSV disease. Evidence from randomized clinical trials and large real-world studies consistently demonstrates that a single dose of Nirsevimab provides season-long protection against RSV-associated LRTI and reduces hospitalization rate across diverse infant populations, while maintaining an excellent safety profile. Emerging data also support its effectiveness in routine clinical practice, although important uncertainties remain regarding long-term epidemiological effects, viral evolution, resistance, comparative effectiveness with maternal immunization, and optimal implementation across different healthcare settings. Current evidence supports Nirsevimab as a major advance in infant RSV prevention. However, continued surveillance, comparative effectiveness studies, and equitable global implementation will be essential to maximize its long-term public health impact. This narrative review summarizes current evidence on Nirsevimab, with emphasis on its clinical efficacy, safety, real-world effectiveness, resistance, implementation challenges, cost-effectiveness, and its role alongside maternal RSV vaccination.
SN - 1010-660X
SN - 1648-9144
ER -