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  1. Article
  2. Source: Campus Sanofi
  3. 7 Nov 2025

RWE data on Nirsevimab and RSV preF vaccine

Author: Sanofi

Editorial Team

Real‑world evidence (RWE) provides valuable insights into the effectiveness, safety, and use of RSV preventive strategies beyond clinical trials. This data support informed decision‑making and optimize the implementation of RSV prevention strategies in real‑world settings

First head-to-head comparison of Nirsevimab vs RSVpreF Vaccine for RSV Related Hospitalization in Newborns in France

Published on: 22nd DECEMBER 2025

Research design and methods:

  • Population based cohort study

Study Population:

  • A total of 42,560 infants were included in the study

Comparison of the public health impact of RSV disease prevention options for infants: 
a static decision model of the US birth cohort

Published on: 25 November 2025

Research design and methods:

  • Using a static decision-analytic model estimated the public health impact  in terms of RSV-related outcomes and costs in a US birth cohort during their first RSV season compared to the pre-2023 SoP of:

Long-acting mAb

It is indicated for prevention of Respiratory Syncytial Virus (RSV) 

lower respiratory tract disease in neonates and infants during their first RSV season.

Maternal vaccination

RSVpreF is a bivalent prefusion-stabilized viral surface protein vaccine4

Licensed for use in pregnancy for passive immunization 
of infants4

 

Results:

 NirsevimabNirsevimab
MA RSV health events364,20476,915
RSV related hospitalization32,4049,649
Emergency room visits88,64717,228
Primary care visits243,1050,029
Primary care visits$1.29 billion $345 million

Conclusion:

“All options are expected to reduce the impact of RSV disease, but giving Nirsevimab to all infants was predicted to prevent the most illnesses, hospitalizations, and costs.”

Results:

Number need to immunize to:                                                 

 

Avert one RS case

Avert one* hospitalization

Avert one ICU

Avert one MV

Avert one ER visit

Avert one primary care visit

Avert one death

nirsevimab - all infants

9

91

324

1,365

34

13

58,668

RSVpref - preterm&term - infants†

 

 

 

 

 

 

 

Seasonal

19

149

498

1,867

84

29

141,639

Year-round

23

222

785

3,233

96

35

174,159

          *Hospitalization here includes cases that resulted in an ICU admission or MV case.

          †Results provided for preterm and term infants only, without accounting for palivizumab eligible infants protection.

      Abbreviations: ER, emergency room; ICU, intensive care unit; MV, mechanical ventilation; RSV, respiratory syncytial virus; SoP, standard of practice.

Conclusion:

“Consistent with the estimated greater benefits with the Nirsevimab strategy, the NNI to avoid an RSV-LRTD-related event was consistently lower compared to the alternative prophylactic options”

Rapid scientific advice on protecting infants against respiratory syncytial virus disease for the European 2025/26 winter season 

Published on: November 2025

 

European Centre for Disease Prevention and Control Publication assessed the different immunization interventions to mitigate the impact of RSV disease in infants published on November 2025

MAb (nirsevimab) vs Maternal Immunization comparison:

Aspect

Nirsevimab (mAb)

Maternal Immunization

Efficacy

76–86% against RSV hospitalization,

 Real-world impact up to 95% reduction

~74% against severe RSV; ~54–78% against hospitalization

Duration of Protection

~5–6 months (covers RSV season)

Up to 6 months post-birth

Babies born out of season will NOT be protected as they enter the RSV season.

Safety

Strong profile; no major concerns

Generally safe; ongoing monitoring for preterm birth risk

Coverage & Uptake

High (>80% in pilots; Spain 90%)

Lower (France 27%, UK 55%)

MAT-BH-2600004/V1/January2026  

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