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Sanofi secures FDA approval for additional flu vaccine manufacturing plant

18 Jun 2021

Commercialisation activities for the US market are already underway for Fluzone High-Dose Quadrivalent

Sanofi's vaccines business, Sanofi Pasteur, has received the go-ahead from the US Food and Drug Administration's Center for Biologics Evaluation and Research for its new $425 million manufacturing facility in Swiftwater, PA.

With the approval, Sanofi has already started production of its Fluzone High-Dose Quadrivalent vaccine — a vaccine designed to offer people 65 years of age and older, protection against four flu viruses — ahead of the 2021–2022 influenza season in the US.

The company's Head of North America Operations, Elain O'Hara, said there is a "fast-growing demand" for the vaccine, given the ten years of data supporting its protection from flu.

According to prescribing information, Fluzone High-Dose Quadrivalent is the only FDA-approved vaccine for superior flu protection in adults 65 years of age and older compared with a standard-dose flu vaccine.

In a statement, the company says it plans to "support other countries in the near future", a sentiment echoed by O'Hara who said the company's combined capacity will produce enough high-dose vaccine for "all people 65 and older in as many countries as possible this flu season and beyond".

The expanded facility will also create up to 200 additional manufacturing jobs.

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