Sanofi, the global leader in influenza vaccines, announced today it has immediately adopted the influenza strains selected by the US Food and Drug Administration (FDA) for the upcoming 2025-26 flu season. The company had already initiated production to ensure robust vaccine supply will be available for the coming season.
The announcement comes as the United States battles one of its most severe influenza seasons in decades, with declining vaccination rates and flu-related hospitalizations reaching a 15-year high.
"The US is weathering one of its most severe flu seasons in decades, underscoring the need to protect people against seasonal influenza infection," said Thomas Grenier, Head of Vaccines, North America at Sanofi. "As the world leader in flu vaccines, Sanofi works relentlessly to ensure we are prepared, which is why our manufacturing does not miss a beat as we provide eligible Americans with a portfolio of immunizations to help protect against flu infection and the potentially serious complications it can cause."
Current Flu Season Severity Highlights Vaccination Importance
According to estimates from the US Centers for Disease Control and Prevention (CDC), the 2024-25 flu season has already resulted in approximately 40 million illnesses, 520,000 hospitalizations, and 22,000 deaths through the week ending March 1, 2025. These alarming statistics emphasize the critical importance of annual influenza vaccination.
Public health authorities nationwide continue to recommend that eligible individuals six months of age and older receive annual flu vaccination to help protect against influenza and its potentially serious complications.
Sanofi's 2025-26 Vaccine Portfolio
Sanofi plans to begin shipping its flu vaccines this summer to ensure health systems, hospitals, pharmacies, physician practices, nursing homes, and other healthcare facilities can begin administering vaccines at the onset of the next flu season.
The company's 2025-26 US influenza season portfolio will include:
- FLUZONE High-Dose: Specifically designed for adults 65 years of age and older
- FLUBLOK: Indicated for people 18 years of age and older
- FLUZONE: Approved for people 6 months of age and older
This comprehensive portfolio is supported by extensive clinical data and aims to provide protection across the lifespan, from young children through older adults who face higher risks from influenza complications.
Manufacturing and Distribution Strategy
The FDA-selected strains for the 2025-26 season match those already used in Sanofi's production process, allowing for seamless continuation of manufacturing. This strategic alignment helps ensure timely availability of vaccines before the start of the next flu season.
Sanofi's proactive approach to vaccine production reflects the company's commitment to public health preparedness, particularly important given the severity of recent influenza seasons and the ongoing challenges in maintaining adequate vaccination rates.
Clinical Significance and Public Health Impact
Influenza remains a significant public health concern, with seasonal epidemics causing substantial morbidity and mortality, particularly among vulnerable populations such as young children, elderly adults, pregnant women, and individuals with chronic health conditions.
Annual vaccination represents the most effective strategy for preventing influenza and its complications. However, vaccination rates have declined in recent years, contributing to increased disease burden.
Healthcare providers are encouraged to begin planning their vaccination campaigns for the 2025-26 season, with Sanofi's early production and distribution timeline facilitating these efforts.
As influenza viruses continue to evolve, the annual reformulation of vaccines based on surveillance data and strain selection by regulatory authorities remains essential to optimize vaccine effectiveness against circulating viruses.
