FDA Approval for Sanofi’s New Influenza Vaccine Production Plant in Swiftwater, PA

The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research has granted approval to Sanofi Pasteur, the vaccines global business unit of Sanofi, for an additional influenza manufacturing facility located in Swiftwater, PA.

Up to 200 new jobs in the new plant

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 and will create up to 200 additional manufacturing jobs. Commercialization activities for the U.S. market are underway, with plans to support other countries in the future.

“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.”

Getting the flu shot, very important, especially in the COVID-19 pandemic

Getting a flu vaccine is very important, especially since the coronavirus pandemic is still underway, and the combined force of the two viruses could prove deadly. Last season, 

Illinois health officials have once again made it clear just how important it was to get a flu shot before winter. Even though vaccines for COVID-19 have been made available, we still do not know for sure how the pandemic will evolve this fall, so getting the flu vaccine, as well as the COVID one, is extremely important, especially for those categories who are at high risk. So, Sanofi being approved to expand their manufacturing facilities is good news, because it means more flu shots are going to be available for the 2021-2022 influenza season. 

Good news for Sanofi, after COVID-19 vaccine set-back

The FDA approval of their new vaccine factory is beneficial to Sanofi, after having experienced a major setback in its goal of quickly producing a Covid-19 vaccine. The issue pushed the release of Sanofi Pasteur’s vaccine back from the first few months of 2021 into the second half of the year, pending approval.

However, the company has had positive results with the PD-1 inhibitor Libtayo® (cemiplimab) monotherapy developed with Regeneron, and used in patients with recurrent or metastatic cervical cancer. The overall survival (OS) benefit from the Phase 3 trial investigating Libtayo®  compared to chemotherapy was announced on March 15th, giving hope to otherwise terminal patients.

About Fluzone High-Dose Quadrivalent

Fluzone High-Dose Quadrivalent is a vaccine indicated for the 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.

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. 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 over 65. 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.

Sanofi is 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.

Outside of the U.S., Sanofi’s High-Dose influenza vaccine has also earned recommendations for use over standard-dose influenza vaccine in individual adults 65 years and older by the National Advisory Committee on Immunization (NACI) in Canada, along with a recommendation for priority use in older adults by Germany’s Standing Committee on Vaccination (STIKO). As the largest manufacturer of influenza vaccines in the world, Sanofi has been continuously investing to expand manufacturing capabilities and it has distributed more than 250 million doses of influenza vaccines globally in 2020. 

Sanofi’s efforts towards influenza prevention

As the leading manufacturer of influenza vaccines, Sanofi is committed to researching, developing, and manufacturing vaccines proved to help protect people against influenza and its related complications.

This new vaccine manufacturing facility further demonstrates Sanofi’s overall growth strategy, with vaccines contributing as a key growth driver through differentiated products, market expansion, and new launches. It builds upon recent investments in France, Canada, and Singapore to strengthen the company’s leadership and capacity to advance the research of new vaccines and produce them on a massive scale.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Important safety precautions

Anyone who has had a previous influenza vaccine or severe allergic reaction to any of the Fluzone High-Dose Quadrivalent’s components, including eggs or egg products,  should not be given this shot.

Tell your health care provider if you have ever had Guillain-Barré syndrome (severe muscle weakness) after previous influenza vaccination.

If Fluzone High-Dose Quadrivalent is given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected.

For Fluzone High-Dose Quadrivalent, in adults 65 years of age and older, the most common side effects were pain, redness, and/or swelling where you got the shot; muscle ache, headache, and general discomfort.