New Beyfortus data at IDWeek confirm real-world effectiveness against RSV in infants

Sanofi is set to reveal new data on Beyfortus (nirsevimab) at the Infectious Disease Society of America’s IDWeek 2024 annual meeting in Los Angeles, from October 16-19. The company aims to highlight the effectiveness of Beyfortus in protecting infants from respiratory syncytial virus (RSV) disease and hospitalization. Thomas Triomphe, Executive Vice President of Vaccines at Sanofi, emphasized that the data from various national immunization programs will underscore Beyfortus' proven efficacy and favorable safety profile. In its first year, Beyfortus has shown real-world effectiveness exceeding 80%. It provides protection in an appropriate dose for different infant needs, making it the only approved antibody for RSV protection in infants, regardless of their birth conditions or health status.

Sanofi is ensuring the availability of Beyfortus doses to meet global commitments for the 2024-2025 RSV season. A second manufacturing line has been approved in the US, Canada, and Europe, representing the bulk of supply for the upcoming season. A third filling line, approved by the European Medicines Agency (EMA) and under review by the US Food and Drug Administration (FDA), is expected to further boost the supply.

The IDWeek 2024 presentations include various studies and reviews on the impact of nirsevimab. On October 17, presentations will cover topics such as the systematic review of early real-world evidence on effectiveness, the implementation and uptake within Nemours Children’s Health Delaware, and a discussion on preventing RSV lower respiratory tract disease in infants. Another presentation will discuss the universal immunization strategy in Chile using nirsevimab during the 2024 winter season. On October 18, independent studies will be presented on the significant reduction in disease burden in Catalonia and preliminary results from the BONSAI study in Brazil. On October 19, AstraZeneca will present findings on how nirsevimab in patient samples does not interfere with RSV detection by commercial rapid antigen tests.

RSV is a highly contagious virus leading to serious respiratory illness in infants. It infects two out of three infants during their first year and nearly all children by their second birthday. RSV is the primary cause of lower respiratory tract diseases such as bronchiolitis and pneumonia in infants and a leading cause of hospitalization worldwide. In 2019, there were about 33 million cases of acute lower respiratory infections in children under five, leading to over 3 million hospitalizations. The direct medical costs associated with RSV were estimated at €4.82 billion globally in 2017.

Beyfortus, the first immunization designed for all infants, offers protection against RSV through their first season and for children up to 24 months who are vulnerable to severe RSV. As a long-acting antibody, Beyfortus provides immediate protection to infants without needing to activate the immune system. Its administration is timed to match the RSV season. Beyfortus has been approved in the European Union, the US, China, Japan, and other countries. Several regulatory agencies have granted special designations to expedite its development, including Breakthrough Therapy Designation and Priority Review designation in China, and Fast Track Designation in the US.

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