French multinational pharmaceutical company Sanofi has commenced the shipping of BEYFORTUS (nirsevimab-alip) to the US, targeting both private healthcare providers and the Centers for Disease Control and Prevention's Vaccines for Children programme, to protect babies against respiratory syncytial virus (RSV) disease.
The company is shipping 50mg and 100mg injection doses.
The strategic move is designed to ensure ample availability of the preventive treatment for babies ahead of the coming RSV season.
The single-dose long-acting antibody BEYFORTUS is engineered to prevent lower respiratory tract disease (LRTD) caused by RSV in infants up to five months old, and to cover the typical duration of the US RSV season from November to March.
It provides immediate protection without the need for immune system activation.
Sanofi North America head of vaccines Thomas Grenier stated: “This accomplishment aimed at equitable access was made possible through close partnership with the White House, Centers for Disease Control and Prevention, the US 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.”
The US market is expected to have a sufficient supply of the antibody, ensuring that every eligible baby can receive immunisation.
Infants born outside the RSV season can be vaccinated during regular check-ups, while those born during the season can access the vaccine at birth.
BEYFORTUS stands out as 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.
In partnership with AstraZeneca, which oversees the development and manufacturing of the antibody, Sanofi has prepared doses on a newly approved filling line.
This development increases the supply for the Northern Hemisphere 2024/2025 RSV season.
An additional filling line is expected to further boost production capacity as Sanofi and AstraZeneca build inventory to meet demand for the upcoming and future RSV seasons.
