Sanofi Ramps Up Early Global Distribution of Beyfortus to Meet Growing RSV Season Demand, Enhancing Protection for Infants Worldwide
In a proactive move to ensure readiness for the 2025-2026 respiratory syncytial virus (RSV) season, Sanofi has announced that shipments of Beyfortus® (nirsevimab) will begin in early Q3 2025. This early global distribution marks a strategic effort to give healthcare providers ample time to prepare for the upcoming RSV season, which typically begins in November and lasts through March. The advance availability of Beyfortus aims to strengthen immunization campaigns and expand access to this critical preventive option for infants across more than 40 countries.
Beyfortus, a long-acting monoclonal antibody developed in partnership with AstraZeneca, is the first and only RSV immunization designed to offer season-long protection for all infants—regardless of whether they are born healthy, preterm, or with underlying medical conditions. Since its launch in 2023, the product has quickly gained recognition for its high and sustained efficacy throughout the RSV season and is supported by a comprehensive body of real-world evidence involving hundreds of thousands of infants.
Strategic Expansion of Manufacturing and Supply Chain
Since introducing Beyfortus, Sanofi and AstraZeneca have significantly expanded manufacturing operations to meet growing global demand. In just two years, they have tripled production capacity and doubled the number of manufacturing sites dedicated to the antibody’s production. For the upcoming 2025-2026 RSV season, Sanofi reports that supply levels already equal the total number of doses distributed during the previous year, with production ongoing to meet anticipated increases in demand.
Last season, enough doses of Beyfortus were produced to cover every infant in the United States, a major milestone underscoring the partners’ commitment to equitable and timely access. The momentum continues as Sanofi enhances its global distribution network to ensure that healthcare providers can rely on consistent and early availability of the immunization in the months leading up to the RSV season.
Strong Clinical Foundation and Global Confidence
Now entering its third year on the market, Beyfortus is being hailed as a transformative innovation in infant healthcare. According to Thomas Triomphe, Executive Vice President of Vaccines at Sanofi, the product has been administered to over 250,000 infants in real-world settings, backed by more than 40 studies demonstrating its effectiveness in preventing RSV lower respiratory tract disease. He emphasized the importance of early and broad access to the immunization, noting that Sanofi’s advanced logistics infrastructure is crucial for meeting the accelerating global demand.
“Our third year of providing RSV protection marks a transformative era in infant health,” Triomphe stated. “Beyfortus has consistently proven itself as an effective RSV immunization. To meet growing demand, we have meticulously primed our global distribution network to ensure Beyfortus will continue to deliver significant public health impact.”
Label Expansion in Europe for Season-Long Protection
In the European Union, Sanofi has received regulatory approval to extend the duration of Beyfortus protection through six months following immunization. This label update means that older infants vaccinated just before the RSV season begins can remain protected throughout the full season. The extension reflects Sanofi’s efforts to maximize the product’s public health value by offering protection across a broader infant age range.
With over six million infants immunized worldwide to date, Beyfortus continues to be embraced by healthcare systems and parents seeking an effective solution against the threat of RSV. Millions more doses are expected to be administered globally during the 2025-2026 RSV season.
RSV: A Major Public Health Challenge for Infants
RSV remains one of the most pervasive and dangerous respiratory viruses affecting infants globally. It is estimated that two out of three infants are infected with RSV in their first year of life, and nearly all children will encounter the virus by the age of two. RSV is the leading cause of lower respiratory tract disease and a top reason for hospitalization among infants. Importantly, most RSV-related hospitalizations occur in healthy, full-term infants who previously showed no signs of underlying health conditions.
The burden of RSV on healthcare systems and families has prompted growing calls for a universal preventive strategy. Beyfortus answers that need by offering protection in a single intramuscular dose, timed to coincide with RSV season peaks. Unlike traditional vaccines, Beyfortus does not require activation of the infant’s immune system to be effective. Instead, the monoclonal antibody immediately delivers passive immunity, offering rapid protection without the need for multiple doses or a waiting period for an immune response to develop.
Extended Protection for Vulnerable Populations
In addition to its benefits for healthy newborns, Beyfortus has been designed to address the needs of children with heightened vulnerability to RSV. The antibody can be administered to children up to 24 months of age who remain at risk for severe RSV complications during their second RSV season, including those with chronic lung disease, congenital heart defects, or premature birth.
A unique feature of Beyfortus is its extended half-life of 71 days, making it the longest-acting monoclonal antibody available for RSV prevention. This pharmacokinetic profile enables season-long protection with a single dose, aligning with the standard length of the RSV season in most regions.
Global Regulatory and Market Recognition
The development and launch of Beyfortus have been expedited through a series of regulatory designations across key markets. The immunization has received fast-track, breakthrough, or priority review status in jurisdictions including the United States, the European Union, Japan, and China. These accelerated pathways were granted based on the compelling clinical need and the product’s potential to significantly reduce the burden of RSV on both individual and systemic levels.
This broad international endorsement has allowed Beyfortus to enter widespread use in a remarkably short time, helping countries implement national immunization strategies to reduce RSV-related hospitalizations and improve pediatric outcomes.
Building a Foundation for Equitable Infant Health
With preparations for the 2025-2026 RSV season well underway, Sanofi’s forward-thinking strategy for early shipment and expanded production of Beyfortus reflects a long-term vision for global infant health. The initiative ensures that healthcare systems can distribute doses on a timeline that supports pre-season immunizations, helping to mitigate the annual strain RSV places on hospitals and families alike.
By aligning scientific innovation with robust manufacturing and distribution capabilities, Sanofi and AstraZeneca are working to redefine how RSV is prevented in infants worldwide. Their shared mission is not only to meet current demand but to build a sustainable and equitable framework for RSV immunization in the years to come.
As the RSV season approaches, the early delivery of Beyfortus ensures that millions of infants—regardless of when or where they are born—will have access to effective protection against a virus that continues to pose a significant threat to pediatric health. With robust supply, evolving label indications, and unmatched real-world evidence, Beyfortus is positioned to remain a cornerstone of RSV prevention on a global scale.
