French pharmaceutical giant Sanofi has begun global shipments of Beyfortus (nirsevimab) ahead of the 2025-2026 respiratory syncytial virus (RSV) season to support healthcare providers and ensure access for all eligible infants.
RSV season typically begins in November, and the early Q3 2025 shipments are intended to align with fall immunizations. The monoclonal antibody is currently the only RSV immunization designed to protect all infants with a single-dose, long-acting formula.
Since its 2023 launch, demand for Beyfortus has steadily increased. To support the growing need, Sanofi and partner AstraZeneca have tripled production capacity and doubled the number of manufacturing sites. For the upcoming season, the companies have already matched last year’s total global dose output, with production still ongoing.
“To meet growing demand since launch, we have meticulously primed our global distribution network to ensure Beyfortus will continue to deliver significant public health impact and offer high, sustained efficacy for infants regardless of underlying health conditions or the timing of when they are born,” Thomas Triomphe, executive vice president for vaccines at Sanofi, said in a statement.
The EU label for Beyfortus was recently updated to extend protection through six months post-administration, allowing season-long coverage even for infants immunized just before the RSV season. To date, more than six million babies have received the antibody worldwide. Sanofi anticipates millions more will be immunized in over 40 countries this season.
RSV remains a leading cause of lower respiratory tract infections and hospitalizations in infants globally. Beyfortus, with a half-life of 71 days, offers sustained protection without requiring immune activation. It is indicated for infants regardless of birth timing, gestational age, or health status, and is approved in major markets including the U.S., EU, Japan, and China.