BEYFORTUS RSV Prevention Doses Distributed Nationwide to Protect Vulnerable Infants

Sanofi has begun shipping BEYFORTUS (nirsevimab-alip) 50mg and 100mg injection doses across the U.S. to both private healthcare providers and the Centers for Disease Control and Prevention (CDC). This shipment is part of the Vaccines for Children (VFC) program, aimed at ensuring widespread availability of BEYFORTUS doses ahead of the respiratory syncytial virus (RSV) season, which typically peaks between November and March. BEYFORTUS, developed in collaboration with AstraZeneca, is the first and only long-acting monoclonal antibody approved for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants entering their first RSV season, as well as in vulnerable children up to 24 months old.

The US market is expected to have an adequate supply, ensuring that babies born outside of the RSV season can receive BEYFORTUS during regular checkups, while those born during the season can be immunized at birth. According to Thomas Grenier, Head of Vaccines, North America at Sanofi, this achievement is the result of collaboration with federal agencies, including the White House and the U.S. FDA, to ensure equitable access.

Sanofi has taken proactive steps to meet demand for the upcoming RSV season by implementing a new filling line for BEYFORTUS doses, which recently received FDA approval. Another filling line is expected to further boost supply for the 2024/2025 season. To better manage distribution, the company also launched the BEYFORTUS Reservation Program, which allows private healthcare providers to request doses and receive priority access.

RSV is a highly contagious virus that causes respiratory infections in infants, leading to serious complications such as bronchiolitis and pneumonia. Each year in the U.S., around 590,000 cases of RSV in babies under one year of age require medical attention. BEYFORTUS is designed to offer fast-acting protection against RSV, lasting for the typical five-month RSV season. It has been approved in several countries, including the U.S the EU, China, and Japan, and has received special regulatory designations for expedited development due to its critical role in pediatric healthcare. 

As RSV season approaches, BEYFORTUS is set to play a crucial role in reducing hospitalizations and protecting infants from severe RSV-related illness.