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FDA licenses new Pennsylvania pharmaceutical facility to manufacture flu vaccine

On Thursday, the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research granted Sanofi Pasteur approval to use their manufacturing facility in Swiftwater, Penn. to make influenza vaccines.

Sanofi’s Swiftwater facility further expands production and distribution of Sanofi’s Fluzone High-Dose Quadrivalent for the upcoming 2021-2022 influenza season and will create up to 200 additional manufacturing jobs.

Sanofi said it had invested $425 million in the facility to create the vaccine for people 65 and older.

“We are experiencing fast-growing demand for our vaccine in the U.S. and globally, given the 10 years of data demonstrating protection from flu and its related complications,” said Elaine O’Hara, Head of North America Commercial Operations for Sanofi Pasteur. “Our new facility will complement our existing capacities to produce enough high-dose vaccine for all people 65 and older in as many countries as possible this flu season and beyond, supporting the needs of healthcare providers and patients.”

The Fluzone High-Dose Quadrivalent vaccine is indicated for preventing those 65 and older from getting sick due to the influenza A and B strains. It is the only vaccine approved by the FDA for superior flu protections in seniors and protects against four strains of the flu. The High-Dose Quadrivalent builds on the legacy of the trivalent formulation, which was proven to be 24.2 percent more effective than the standard dose of Fluzone.

Liz Carey

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