Sanofi ships BEYFORTUS to US for infant RSV prevention

Sanofi, a French multinational pharmaceutical company, has started the distribution of BEYFORTUS (nirsevimab-alip) to the United States. This initiative targets both private healthcare providers and the Centers for Disease Control and Prevention’s Vaccines for Children program, aiming to protect infants from respiratory syncytial virus (RSV) disease. Sanofi is providing 50mg and 100mg injection doses of the antibody.

This strategic move is intended to ensure that there is sufficient availability of the preventive treatment for infants before the upcoming RSV season. BEYFORTUS is a single-dose, long-acting antibody specifically designed to prevent lower respiratory tract disease (LRTD) caused by RSV in infants up to five months old. The protection it offers is immediate and does not require activation of the immune system, covering the typical US RSV season from November to March.

Thomas Grenier, head of vaccines for Sanofi North America, highlighted the collaborative efforts with the White House, Centers for Disease Control and Prevention, the US Food and Drug Administration, and healthcare providers. He emphasized that such partnerships were crucial in making BEYFORTUS widely accessible. Grenier expressed optimism that the antibody would provide significant real-world protection to a large number of infants during the upcoming season.

The US market is expected to have an ample supply of the antibody, ensuring that every eligible infant can receive immunization. Infants born outside the RSV season will be able to get vaccinated during routine check-ups, while those born during the season can receive the vaccine at birth.

BEYFORTUS is unique as it is the first and only long-acting monoclonal antibody approved for preventing RSV LRTD in newborns and infants during their first RSV season. It is also available for children up to 24 months who are at risk of severe disease in their second season of RSV.

Sanofi has collaborated with AstraZeneca, which manages the development and manufacturing of the antibody. The companies have prepared doses using a newly approved filling line, thereby boosting the supply for the Northern Hemisphere’s 2024/2025 RSV season. Additionally, a new filling line is expected to further increase production capacity, enabling both companies to build sufficient inventory to meet the demands of future RSV seasons. This effort underscores Sanofi and AstraZeneca’s commitment to providing critical protection against RSV to infants, ensuring that preventive measures are in place well ahead of the season.

The proactive steps taken by Sanofi and AstraZeneca aim to safeguard the health of infants by making BEYFORTUS widely available and ensuring that the supply meets the demand. These measures are critical to managing and mitigating the impact of RSV among infants, particularly during their most vulnerable months.