Newly licensed U.S. manufacturing facility increased availability of Fluzone high-dose quadrivalent (influenza vaccine)

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On Jun. 17, 2021, the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research granted approval to Sanofi Pasteur for an additional influenza manufacturing facility located in Swiftwater, PA.

The newly completed facility expanded production and distribution of Sanofi’s Fluzone High-Dose Quadrivalent for the upcoming 2021-2022 influenza season in the U.S. and up to 200 additional manufacturing jobs. Fluzone High-Dose Quadrivalent is a vaccine indicated for prevention of influenza disease caused by influenza A and B strains contained in the vaccine. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older.1

Fluzone High-Dose Quadrivalent is the only vaccine approved by the U.S. FDA for superior flu protection in adults 65 years of age and older, compared to a standard-dose flu vaccine.1 With 4-strain protection, Fluzone High-Dose Quadrivalent builds on the legacy of the trivalent formulation, which was clinically proven to be 24.2% more effective at preventing flu than standard-dose Fluzone (Influenza Vaccine) in adults 65+.2 Based on data from Fluzone High-Dose (Influenza Vaccine), side effects were slightly more frequent after vaccination with Fluzone High-Dose compared to a standard-dose vaccine.

In addition, Fluzone High-Dose has demonstrated protection against influenza and its related complications including cardiorespiratory events, pneumonia and hospitalization.

he efficacy of trivalent formulation is relevant to Fluzone High-Dose Quadrivalent since both products are manufactured according to the same process and have overlapping compositions.

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Source: Sanofi Genzyme
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