Efficacy of nirsevimab for the prevention of RSV disease in infants: A systematic review, meta-analysis of randomized controlled trials, and global perspectives on recommendations and unmet needs
Respiratory syncytial virus (RSV) is a major cause of infant hospitalizations, with limited prophylactic options historically available. Nirsevimab, a long-acting monoclonal antibody, has emerged as a promising agent for preventing RSV. To evaluate the efficacy and safety of nirsevimab through a sys...
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| Veröffentlicht in: | Pediatrics and neonatology |
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Elsevier B.V
13.11.2025
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| Abstract | Respiratory syncytial virus (RSV) is a major cause of infant hospitalizations, with limited prophylactic options historically available. Nirsevimab, a long-acting monoclonal antibody, has emerged as a promising agent for preventing RSV.
To evaluate the efficacy and safety of nirsevimab through a systematic review and meta-analysis of randomized controlled trials (RCTs) and investigate current global recommendations.
Databases, including PubMed, Embase, and Cochrane CENTRAL, were searched from inception to January 31, 2025. Eligible RCTs assessing nirsevimab efficacy in RSV prevention were included. Outcomes encompassed RSV-related hospitalization, severe infection, and adverse events. Meta-analysis employed random-effects models.
Six RCTs (n = 12,086) were included. Nirsevimab significantly reduced RSV-related hospitalization (odds ratio [OR], 0.19; 95 % confidence interval [CI], 0.13–0.30) and severe RSV infection (OR, 0.23; 95 % CI, 0.12–0.44), with no increase in adverse events. Country-specific recommendations varied, ranging from seasonal to year-round strategies.
Nirsevimab exhibits excellent efficacy and safety in RSV prevention. Although most countries align administration with RSV seasonality, Taiwan distinctively endorses year-round prophylaxis. Customized immunization policies considering local epidemiology and seasonality may optimize protection and inform global RSV prevention strategies. |
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| AbstractList | Respiratory syncytial virus (RSV) is a major cause of infant hospitalizations, with limited prophylactic options historically available. Nirsevimab, a long-acting monoclonal antibody, has emerged as a promising agent for preventing RSV.
To evaluate the efficacy and safety of nirsevimab through a systematic review and meta-analysis of randomized controlled trials (RCTs) and investigate current global recommendations.
Databases, including PubMed, Embase, and Cochrane CENTRAL, were searched from inception to January 31, 2025. Eligible RCTs assessing nirsevimab efficacy in RSV prevention were included. Outcomes encompassed RSV-related hospitalization, severe infection, and adverse events. Meta-analysis employed random-effects models.
Six RCTs (n = 12,086) were included. Nirsevimab significantly reduced RSV-related hospitalization (odds ratio [OR], 0.19; 95 % confidence interval [CI], 0.13–0.30) and severe RSV infection (OR, 0.23; 95 % CI, 0.12–0.44), with no increase in adverse events. Country-specific recommendations varied, ranging from seasonal to year-round strategies.
Nirsevimab exhibits excellent efficacy and safety in RSV prevention. Although most countries align administration with RSV seasonality, Taiwan distinctively endorses year-round prophylaxis. Customized immunization policies considering local epidemiology and seasonality may optimize protection and inform global RSV prevention strategies. Respiratory syncytial virus (RSV) is a major cause of infant hospitalizations, with limited prophylactic options historically available. Nirsevimab, a long-acting monoclonal antibody, has emerged as a promising agent for preventing RSV. To evaluate the efficacy and safety of nirsevimab through a systematic review and meta-analysis of randomized controlled trials (RCTs) and investigate current global recommendations. Databases, including PubMed, Embase, and CENTRAL, were searched from inception to January 31, 2025. Eligible RCTs assessing nirsevimab efficacy in RSV prevention were included. Outcomes encompassed RSV-related hospitalization, severe infection, and adverse events. Meta-analysis employed random-effects models. Six RCTs (n = 12,086) were included. Nirsevimab significantly reduced RSV-related hospitalization (odds ratio [OR], 0.19; 95% confidence interval [CI], 0.13–0.30) and severe RSV infection (OR, 0.23; 95% CI, 0.12–0.44), with no increase in adverse events. Country-specific recommendations varied, ranging from seasonal to year-round strategies. Nirsevimab exhibits excellent efficacy and safety in RSV prevention. Although most countries align administration with RSV seasonality, Taiwan distinctively endorses year-round prophylaxis. Customized immunization policies considering local epidemiology and seasonality may optimize protection and inform global RSV prevention strategies. AbstractBackgroundRespiratory syncytial virus (RSV) is a major cause of infant hospitalizations, with limited prophylactic options historically available. Nirsevimab, a long-acting monoclonal antibody, has emerged as a promising agent for preventing RSV. ObjectiveTo evaluate the efficacy and safety of nirsevimab through a systematic review and meta-analysis of randomized controlled trials (RCTs) and investigate current global recommendations. MethodsDatabases, including PubMed, Embase, and CENTRAL, were searched from inception to January 31, 2025. Eligible RCTs assessing nirsevimab efficacy in RSV prevention were included. Outcomes encompassed RSV-related hospitalization, severe infection, and adverse events. Meta-analysis employed random-effects models. ResultsSix RCTs (n = 12,086) were included. Nirsevimab significantly reduced RSV-related hospitalization (odds ratio [OR], 0.19; 95% confidence interval [CI], 0.13–0.30) and severe RSV infection (OR, 0.23; 95% CI, 0.12–0.44), with no increase in adverse events. Country-specific recommendations varied, ranging from seasonal to year-round strategies. ConclusionNirsevimab exhibits excellent efficacy and safety in RSV prevention. Although most countries align administration with RSV seasonality, Taiwan distinctively endorses year-round prophylaxis. Customized immunization policies considering local epidemiology and seasonality may optimize protection and inform global RSV prevention strategies. Respiratory syncytial virus (RSV) is a major cause of infant hospitalizations, with limited prophylactic options historically available. Nirsevimab, a long-acting monoclonal antibody, has emerged as a promising agent for preventing RSV.BACKGROUNDRespiratory syncytial virus (RSV) is a major cause of infant hospitalizations, with limited prophylactic options historically available. Nirsevimab, a long-acting monoclonal antibody, has emerged as a promising agent for preventing RSV.To evaluate the efficacy and safety of nirsevimab through a systematic review and meta-analysis of randomized controlled trials (RCTs) and investigate current global recommendations.OBJECTIVETo evaluate the efficacy and safety of nirsevimab through a systematic review and meta-analysis of randomized controlled trials (RCTs) and investigate current global recommendations.Databases, including PubMed, Embase, and Cochrane CENTRAL, were searched from inception to January 31, 2025. Eligible RCTs assessing nirsevimab efficacy in RSV prevention were included. Outcomes encompassed RSV-related hospitalization, severe infection, and adverse events. Meta-analysis employed random-effects models.METHODSDatabases, including PubMed, Embase, and Cochrane CENTRAL, were searched from inception to January 31, 2025. Eligible RCTs assessing nirsevimab efficacy in RSV prevention were included. Outcomes encompassed RSV-related hospitalization, severe infection, and adverse events. Meta-analysis employed random-effects models.Six RCTs (n = 12,086) were included. Nirsevimab significantly reduced RSV-related hospitalization (odds ratio [OR], 0.19; 95 % confidence interval [CI], 0.13-0.30) and severe RSV infection (OR, 0.23; 95 % CI, 0.12-0.44), with no increase in adverse events. Country-specific recommendations varied, ranging from seasonal to year-round strategies.RESULTSSix RCTs (n = 12,086) were included. Nirsevimab significantly reduced RSV-related hospitalization (odds ratio [OR], 0.19; 95 % confidence interval [CI], 0.13-0.30) and severe RSV infection (OR, 0.23; 95 % CI, 0.12-0.44), with no increase in adverse events. Country-specific recommendations varied, ranging from seasonal to year-round strategies.Nirsevimab exhibits excellent efficacy and safety in RSV prevention. Although most countries align administration with RSV seasonality, Taiwan distinctively endorses year-round prophylaxis. Customized immunization policies considering local epidemiology and seasonality may optimize protection and inform global RSV prevention strategies.CONCLUSIONNirsevimab exhibits excellent efficacy and safety in RSV prevention. Although most countries align administration with RSV seasonality, Taiwan distinctively endorses year-round prophylaxis. Customized immunization policies considering local epidemiology and seasonality may optimize protection and inform global RSV prevention strategies. |
| Author | Tai, Yu-Lin Huang, Ya-Ning Chi, Hsin Lien, Hsin-Chweng Chiu, Nan-Chang Weng, Shun-Long Lin, Chien-Yu Liu, Tzu-Yu Lien, Chi-Hone Yeung, Chun-Yan |
| Author_xml | – sequence: 1 givenname: Hsin-Chweng surname: Lien fullname: Lien, Hsin-Chweng organization: Hsinchu Municipal MacKay Children's Hospital, Hsinchu City, Taiwan – sequence: 2 givenname: Chi-Hone surname: Lien fullname: Lien, Chi-Hone organization: Hsinchu Municipal MacKay Children's Hospital, Hsinchu City, Taiwan – sequence: 3 givenname: Tzu-Yu surname: Liu fullname: Liu, Tzu-Yu organization: Hsinchu Municipal MacKay Children's Hospital, Hsinchu City, Taiwan – sequence: 4 givenname: Shun-Long surname: Weng fullname: Weng, Shun-Long organization: Hsinchu Municipal MacKay Children's Hospital, Hsinchu City, Taiwan – sequence: 5 givenname: Yu-Lin orcidid: 0000-0002-0433-1072 surname: Tai fullname: Tai, Yu-Lin organization: Hsinchu Municipal MacKay Children's Hospital, Hsinchu City, Taiwan – sequence: 6 givenname: Ya-Ning surname: Huang fullname: Huang, Ya-Ning organization: Hsinchu Municipal MacKay Children's Hospital, Hsinchu City, Taiwan – sequence: 7 givenname: Hsin orcidid: 0000-0002-2385-344X surname: Chi fullname: Chi, Hsin organization: MacKay Medical College, New Taipei City, Taiwan – sequence: 8 givenname: Nan-Chang surname: Chiu fullname: Chiu, Nan-Chang organization: MacKay Medical College, New Taipei City, Taiwan – sequence: 9 givenname: Chun-Yan surname: Yeung fullname: Yeung, Chun-Yan organization: Hsinchu Municipal MacKay Children's Hospital, Hsinchu City, Taiwan – sequence: 10 givenname: Chien-Yu orcidid: 0000-0003-4630-8724 surname: Lin fullname: Lin, Chien-Yu email: mmhped.lin@gmail.com organization: Hsinchu Municipal MacKay Children's Hospital, Hsinchu City, Taiwan |
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| Copyright | 2025 Taiwan Pediatric Association Taiwan Pediatric Association Copyright © 2025 Taiwan Pediatric Association. Published by Elsevier B.V. All rights reserved. |
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| Keywords | Beyfortus Respiratory syncytial virus RSV Seasonality Passive immunity Monoclonal antibody Traveller Nirsevimab passive immunity monoclonal antibody respiratory syncytial virus traveller seasonality nirsevimab |
| Language | English |
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| Title | Efficacy of nirsevimab for the prevention of RSV disease in infants: A systematic review, meta-analysis of randomized controlled trials, and global perspectives on recommendations and unmet needs |
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