Sanofi shipping BEYFORTUS in US to help protect babies against RSV disease; new manufacturing line approved by FDA

Sanofi is shipping BEYFORTUS (nirsevimab-alip) 50mg and 100mg Injection doses in the US to private healthcare providers and to the Centers for Disease Control and Prevention for its Vaccines for Children program to help ensure the majority of doses are available ahead of RSV season. The US market is anticipated to have enough supply so that every eligible baby born outside of the season will have access to immunization at a regular checkup and those born during the season will have access 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, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Thomas Grenier
Head of Vaccines, North America, Sanofi
“We’re proud to offer BEYFORTUS doses to help protect every eligible baby in the US this RSV season. This accomplishment aimed at equitable access was made possible through close partnership with the White House, Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, and healthcare providers to make BEYFORTUS widely available. This upcoming season, we look forward to BEYFORTUS offering its demonstrated real-world protection to as many infants as possible.”

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 took additional measures to ensure greater readiness for this season by launching the BEYFORTUS Reservation Program, which provides critical insight on private healthcare provider demand and allows for prioritized fulfillment of requests placed through the program. The company also continues to collaborate with government agencies, including the White House’s Office of Pandemic Preparedness and Response Policy, to ensure readiness.