Sanofi announced today that it’s shipping Beyfortus injection doses to the U.S. to ensure availability ahead of respiratory syncytial virus (RSV) season.
The company shipped 50mg and 100mg injection doses of Beyfortus (nirsevimab-alip) to private healthcare providers and the Centers for Disease Control and Prevention for its Vaccines for Children program. Sanofi expects the U.S. market to have enough supply so every eligible baby born outside the season can access immunization at a regular checkup and those born during the season can access the therapeutic at birth.
Beyfortus is the first and only long-acting monoclonal antibody approved for preventing 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.
In collaboration with AstraZeneca, which leads Beyfortus development and manufacturing, Sanofi already produced and packaged doses on a new filling line. The company recently received FDA approval for this line and now has those doses ready to ship, expanding supply for the Northern Hemisphere for the RSV season (between November and March). Sanofi expects another filling line to provide doses and add more capacity.
The company says it took additional measures to ensure greater readiness for the RSV season with its Beyfortus Reservation Program. This provides critical insights into private healthcare provider demand and allows for prioritized fulfillment of requests placed through the program. Sanofi also plans to continue working with government agencies on this front.
“We’re proud to offer Beyfortus doses to help protect every eligible baby in the U.S. this RSV season,” said Thomas Grenier, Sanofi head of vaccines, North America. “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.”
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