Press Release

Beyfortus real-world evidence published in The Lancet shows 82% reduction in infant RSV hospitalizations - Seite 2

Thomas Triomphe
Executive Vice President, Vaccines, Sanofi
“The scale and speed of impact seen after Beyfortus’ introduction demonstrates the strength of all-infant immunization strategies against RSV in babies. In Galicia, we saw an effectiveness of 82% in reducing RSV hospitalizations following the launch of Beyfortus, with more than 90% of eligible infants immunized. A growing body of evidence from these programs support policymakers, healthcare providers and parents who share our collective ambition to safeguard babies from RSV disease.”

NIRSE-GAL is a large, population-based, three-year follow-up study to evaluate the effectiveness of Beyfortus following its inclusion in the Galician immunization schedule. The study aims to measure the impact of Beyfortus on hospitalizations due to RSV, all-cause lower respiratory tract disease, severe lower respiratory tract disease caused by RSV, all-cause lower respiratory tract disease hospitalizations, and all-cause hospitalizations among infants born during the RSV season, infants under 6 months of age at the start of the season, and children aged 6-24 months who are vulnerable to severe RSV disease at the start of the season. The 2023-2024 immunization campaign ran from September 25, 2023 to March 31, 2024.¹

RWE from countries with Beyfortus all-infant immunization programs in 2023-24

In addition to this new effectiveness study, evidence of the high impact following Beyfortus’ introduction has been consistently shown in several other real-world studies.

• An interim analysis of 2023-24 surveillance data published in the US Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report (MMWR) shows a single dose of Beyfortus was 90% effective in preventing hospitalizations due to RSV in babies who were immunized below 8 months of age.²
  
  
• A recent draft recommendation from Haute Autorité de Santé in France reported, across six hospitals, an effectiveness of 83% against RSV-associated hospitalization in infants who received Beyfortus compared to those with no intervention.³  
  
  
• In Catalonia, Spain, a study pre-printed in The Lancet showed reductions of 87.6% and 90.1% in hospital and ICU admissions for RSV, respectively, among babies born before the start of the RSV season, who were eligible to receive Beyfortus, compared to those with no intervention.⁴
  
  
• A pooled analysis of data from three Spanish regions, including Valencia, Murcia, and Valladolid, showed an 84.4% effectiveness in preventing hospitalizations due to RSV in infants under 9 months of age versus infants who received no intervention. The results were published in Eurosurveillance.⁵