Sanofi has begun shipping doses of Beyfortus® (nirsevimab-alip) 50mg and 100mg Injection in the United States to private healthcare providers and the Centers for Disease Control and Prevention (CDC). This initiative aims to ensure that the majority of doses are available ahead of the respiratory syncytial virus (RSV) season. The U.S. market anticipates having sufficient supply to provide immunization access to every eligible baby born outside the RSV season during regular checkups and to those born during the season at birth.
Beyfortus is the first and only long-acting monoclonal antibody approved for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. It is also approved for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Addressing RSV in Infants
RSV is a highly contagious virus, with two out of three infants contracting it during their first year of life. By their second birthday, almost all children have been infected. While most cases result in mild, cold-like symptoms, RSV is the most common cause of LRTD, including bronchiolitis and pneumonia, in infants. RSV LRTD is the leading cause of hospitalization in babies under one year old, with most hospitalizations occurring in healthy, term infants. Annually, an estimated 590,000 RSV cases in babies under one require medical care in the U.S.
Beyfortus: A Long-Acting Antibody for RSV Prevention
Beyfortus is administered as a single dose and is designed to help prevent RSV LRTD in infants through five months, which aligns with the typical RSV season in the U.S. For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose is recommended post-surgery once the child is stable. An additional dose is also indicated for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season, regardless of body weight.
As a long-acting antibody, Beyfortus offers fast-acting protection to help prevent lower respiratory tract disease caused by RSV without requiring activation of the immune system. Its administration can be timed to coincide with the RSV season.
Manufacturing and Supply Expansion
In collaboration with AstraZeneca, which leads BEYFORTUS development and manufacturing, doses have already been produced and packaged on a new filling line for BEYFORTUS. With the recent FDA approval of this filling line, these doses are now ready to ship, expanding supply for the Northern Hemisphere ahead of the 2024/2025 RSV season (November – March). Another filling line is expected to provide doses for the 2024/2025 season, adding additional production capacity. Sanofi continues to work with AstraZeneca to build inventory for this and future seasons.
Sanofi also launched the BEYFORTUS Reservation Program to gain insight into private healthcare provider demand and prioritize fulfillment of requests. The company continues to collaborate with government agencies, including the White House’s Office of Pandemic Preparedness and Response Policy, to ensure readiness.
Expert Commentary
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 season... This upcoming season, we look forward to BEYFORTUS offering its demonstrated real-world protection to as many infants as possible."
