Sanofi Facility for Flu Vaccine Licensed by FDA

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Sanofi’s new Pennsylvania facility expands production of Fluzone High-Dose Quadrivalent flu vaccine.

FDA’s Center for Biologics Evaluation and Research has given approval to Sanofi Pasteur, the vaccines global business unit of Sanofi, for an additional influenza manufacturing facility located at its existing site in Swiftwater, Pa., the company announced in a June 17, 2021 press release. The newly completed facility further expands production and distribution of Sanofi's Fluzone High-Dose Quadrivalent for the upcoming 2021–2022 influenza season in the United States. The company invested $425 million to build the capacity, which will create up to 200 additional manufacturing jobs.

"We are experiencing fast-growing demand for our vaccine in the US 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, in the press release. "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 US approved the quadrivalent form of the high-dose vaccine in November 2019 for adults age 65 and older, and it replaces the trivalent form of the vaccine. Outside of the US, the vaccine has earned recommendations for use by the National Advisory Committee on Immunization (NACI) in Canada and a recommendation for priority use in older adults by Germany's Standing Committee on Vaccination (STIKO).


In March 2021, Sanofi announced that it would invest in a new vaccine manufacturing facility for Fluzone High-Dose Quadrivalent influenza vaccine at its existing site in Toronto, Canada; this facility is expected to become operational in 2026. The company is also building a facility for this vaccine in Val-de-Reuil, France.

Source: Sanofi