Sanofi Begins Early Global Distribution of Beyfortus to Strengthen RSV Protection for 2025–2026 Season

(IN BRIEF) Sanofi has launched early global shipments of Beyfortus (nirsevimab) in anticipation of the 2025–2026 RSV season, enabling healthcare providers to begin immunizations well before the typical onset of infections in November. In collaboration with AstraZeneca, Sanofi has significantly expanded manufacturing capacity and global supply chains to meet increasing demand. Beyfortus, the only RSV immunization designed for all infants, now offers season-long protection through six months in the EU and has been administered to over six million infants worldwide. It provides single-dose, rapid protection without relying on immune activation and can also help protect vulnerable children up to two years old. The proactive rollout reflects Sanofi’s ongoing commitment to advancing infant health and supporting public health goals globally.

(PRESS RELEASE) PARIS, 9-Jun-2025 — /EuropaWire/ — Sanofi has begun global shipments of Beyfortus (nirsevimab) ahead of schedule, with distribution starting in early Q3 to ensure healthcare providers are fully prepared for the 2025–2026 respiratory syncytial virus (RSV) season. Typically running from November through March, the RSV season poses significant risks to infants. With immunizations beginning in early fall, these advance shipments aim to provide confidence and readiness across medical facilities. Beyfortus remains the only RSV immunization designed for all infants, offering sustained, high-level protection validated by a robust set of real-world data.

Since the 2023 launch of Beyfortus, Sanofi, in partnership with AstraZeneca, has significantly scaled up its manufacturing capabilities—tripling production capacity and doubling its manufacturing sites. For the upcoming season, Sanofi has already produced as many doses as were distributed last year, with production ongoing. During the previous RSV season in the US, enough Beyfortus doses were available to immunize every infant, highlighting the companies’ dedication to making this vital preventive treatment accessible worldwide.

According to Thomas Triomphe, Executive Vice President of Vaccines at Sanofi, “Our third season delivering RSV protection represents a critical evolution in safeguarding infant health. With over 40 real-world studies covering 250,000 infants, Beyfortus has shown consistent effectiveness. We have expanded our global distribution infrastructure to meet growing demand and continue delivering a substantial public health benefit.”

For the 2025 season, European shipments will feature an updated label reflecting an extended duration of protection through six months, making Beyfortus even more effective for older infants vaccinated near the onset of the RSV season. With more than six million infants immunized globally and over 40 countries participating in Beyfortus distribution, the therapy continues to play a pivotal role in reducing the burden of RSV disease.

RSV remains one of the most contagious respiratory infections, affecting two-thirds of infants in their first year and nearly all by the age of two. It is the leading cause of lower respiratory tract illness and hospitalizations among infants, with most hospitalizations occurring in otherwise healthy, full-term babies.

Beyfortus differentiates itself with an extended half-life of 71 days, making it the longest-acting monoclonal antibody for RSV prevention in infants. It provides protection with just one dose, independent of the infant’s immune response. Approved in major markets including the US, EU, Japan, and China, Beyfortus is designed for all infants—regardless of when they are born, their health status, or gestational age—and may also be used to protect vulnerable children up to 24 months old through their second RSV season.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Sanofi Begins Early Global Distribution of Beyfortus to Strengthen RSV Protection for 2025–2026 Season

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