Sanofi Ships Beyfortus in US to Protect Infants Against RSV
Key Insights
Sanofi is shipping Beyfortus (nirsevimab-alip (search)) doses in the US to help protect infants against RSV (search), aiming for equitable access through partnerships with government agencies.
The FDA approved a new Beyfortus filling line, expanding manufacturing capacity to meet anticipated demand for the 2024/2025 RSV (search) season.
Beyfortus is the first and only long-acting monoclonal antibody approved for preventing RSV (search) lower respiratory tract disease in newborns and infants.
Sanofi has begun shipping doses of BEYFORTUS® (nirsevimab-alip (search)) in the US to combat Respiratory Syncytial Virus (search) (RSV (search)) in infants. The company is collaborating with healthcare providers and the CDC to ensure availability ahead of the RSV season. This initiative aims to provide every eligible baby with access to immunization, whether born during or outside the RSV season.
Manufacturing Expansion
A new BEYFORTUS filling line has been approved by the FDA, which will significantly expand manufacturing capacity. This expansion is crucial to meet the anticipated demand for the 2024/2025 RSV (search) season (November – March). AstraZeneca leads BEYFORTUS development and manufacturing, and Sanofi continues to work with them to build inventory for both current and future seasons.
Clinical Significance of Beyfortus
BEYFORTUS is the first and only long-acting monoclonal antibody approved for the prevention of RSV (search) lower respiratory tract disease (LRTD) in newborns and infants during their first RSV season, and for children up to 24 months who remain vulnerable through their second season. The single-dose antibody offers fast-acting protection without requiring activation of the immune system.
RSV Disease Burden
RSV (search) is a highly contagious virus, with two out of three infants contracting it during their first year. It is the most common cause of LRTD, including bronchiolitis and pneumonia, in infants. In the US, an estimated 590,000 RSV cases in babies under one require medical care annually, making it a leading cause of hospitalization in this age group.
Sanofi's Commitment
Thomas Grenier, Head of Vaccines, North America, Sanofi, stated, "We're proud to offer BEYFORTUS doses to help protect every eligible baby in the US this RSV (search) season... We look forward to BEYFORTUS offering its demonstrated real-world protection to as many infants as possible."
Sanofi has also launched the BEYFORTUS Reservation Program to gain insight into healthcare provider demand and prioritize fulfillment. The company continues to collaborate with government agencies to ensure readiness for the RSV (search) season.