Modeling the Public Health Impact of Nirsevimab and Maternal Vaccination With RSVpreF Against Infant Respiratory Syncytial Virus Infection in Germany
Author(s)
Moritz Wick, MSc1, Matthieu Beuvelet, PharmD2, Oliver Damm, DrPH1.
1Sanofi-Aventis Deutschland GmbH, Berlin, Germany, 2Sanofi Vaccines, Lyon, France.
1Sanofi-Aventis Deutschland GmbH, Berlin, Germany, 2Sanofi Vaccines, Lyon, France.
OBJECTIVES: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection (LRTI) in infants worldwide. This study aims to estimate the public health impact of nirsevimab, an extended half-life monoclonal antibody targeting the RSV prefusion F protein, and the bivalent RSV prefusion F protein-based vaccine (RSVpreF) administered during pregnancy in Germany.
METHODS: A static, population-based decision-analytic model was developed to follow monthly German birth cohorts through their first RSV season. The model compared two prevention strategies: (1) an "all-infant" approach with Nirsevimab, with catch-up immunization for pre-RSV season births in October and immediate post-birth administration for in-season births; and (2) year-round maternal vaccination with RSVpreF at 32-36 weeks’ gestation. Both interventions were compared against the pre-2024 standard of care (SoC) in Germany: (3) palivizumab for high-risk infants (<29 weeks of gestational age (wGA), bronchopulmonary dysplasia, or hemodynamically significant congenital heart disease) and no prophylaxis for otherwise healthy infants born preterm (≥29 wGA) and at term. Coverage rates of immunization with nirsevimab and maternal immunization with RSVpreF were standardized at 80% across all newborns and pregnant women, respectively.
RESULTS: The model estimated that nirsevimab could prevent approximately 82,000 medically attended RSV-LRTI cases annually, comprising 8,600 hospitalizations (63% reduction compared with the previous SoC) and 73,400 outpatient cases (59% reduction). In comparison, year-round maternal vaccination with RSVpreF, at the same coverage rate, was projected to prevent 29,900 medically attended cases, including 4,000 hospitalizations (29% reduction) and 25,900 outpatient cases (21% reduction). When stratified by monthly birth cohort, nirsevimab was associated with a consistently greater reduction in medically attended RSV-LRTI cases compared to maternal vaccination, assuming equal coverage levels.
CONCLUSIONS: Our study suggests a higher public health impact for an all-infants immunization strategy with nirsevimab than for year-round maternal vaccination with RSVpreF when compared with the previous SoC in Germany.
METHODS: A static, population-based decision-analytic model was developed to follow monthly German birth cohorts through their first RSV season. The model compared two prevention strategies: (1) an "all-infant" approach with Nirsevimab, with catch-up immunization for pre-RSV season births in October and immediate post-birth administration for in-season births; and (2) year-round maternal vaccination with RSVpreF at 32-36 weeks’ gestation. Both interventions were compared against the pre-2024 standard of care (SoC) in Germany: (3) palivizumab for high-risk infants (<29 weeks of gestational age (wGA), bronchopulmonary dysplasia, or hemodynamically significant congenital heart disease) and no prophylaxis for otherwise healthy infants born preterm (≥29 wGA) and at term. Coverage rates of immunization with nirsevimab and maternal immunization with RSVpreF were standardized at 80% across all newborns and pregnant women, respectively.
RESULTS: The model estimated that nirsevimab could prevent approximately 82,000 medically attended RSV-LRTI cases annually, comprising 8,600 hospitalizations (63% reduction compared with the previous SoC) and 73,400 outpatient cases (59% reduction). In comparison, year-round maternal vaccination with RSVpreF, at the same coverage rate, was projected to prevent 29,900 medically attended cases, including 4,000 hospitalizations (29% reduction) and 25,900 outpatient cases (21% reduction). When stratified by monthly birth cohort, nirsevimab was associated with a consistently greater reduction in medically attended RSV-LRTI cases compared to maternal vaccination, assuming equal coverage levels.
CONCLUSIONS: Our study suggests a higher public health impact for an all-infants immunization strategy with nirsevimab than for year-round maternal vaccination with RSVpreF when compared with the previous SoC in Germany.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EPH163
Topic
Epidemiology & Public Health, Health Technology Assessment
Topic Subcategory
Public Health
Disease
Pediatrics, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory), Vaccines