Building its world-leading flu vaccine capacity, Sanofi scores FDA nod for $425M plant in PA

Three months after revealing a plan to build a €600 million flu vaccine plant in Toronto, Sanofi received good news about another flu shot factory in North America.

The FDA has approved Sanofi's newly completed plant in Swiftwater, Pennsylvania. The license will allow Sanofi to begin production of its Fluzone High-Dose vaccine for the 2021-22 flu season.

The opening of the new plant will require Sanofi to add up to 200 employees as it cranks out shots for the United States this year and for other countries in the future.

Fluzone High-Dose is a quadrivalent vaccine targeting four flu strains. High-dose vaccines have been gaining in popularity as they offer better protection for people 65 and older.  

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“We are experiencing fast-growing demand for our vaccine in the U.S. and globally, given 10 years of data demonstrating protection from flu and its related complications,” Elaine O’Hara, Sanofi’s head of commercial operations in North America, said in a statement.

Sanofi is the leading manufacturer of flu shots in the world, producing the shots from four other international sites—Pearl River (New York), Val-de-Reuil (France), Ocoyacac (Mexico) and Shenzhen (China). Last year, the company distributed more than 250 million flu vaccine doses.

The new facility is on a Swiftwater campus that spans more than 500 acres and includes more than 60 buildings in the Pocono Mountains. The site is the largest producer of flu shots in the U.S. It also manufactures vaccines for seven other diseases. 

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Sanofi’s vaccine business has soared during the pandemic, generating €2.5 billion in global sales, a 38% increase from 2019.

Meanwhile, Sanofi's Toronto plant, due for completion in 2026, is part of Sanofi’s “overall growth strategy of which vaccines will be a major contributor,” a company spokesman said upon the announcement in late March.