FDA licenses Sanofi Pasteur's new flu vaccine manufacturing facility

May 7 2009

Sanofi Pasteur announced today that the U.S. Food and Drug Administration (FDA) has licensed its new influenza vaccine manufacturing facility.

This new facility, located in Swiftwater, Pennsylvania, will incorporate the latest technology in egg-based vaccine production as part of the company's commitment to produce the largest number of doses of vaccine in the shortest time frame to address the threat of seasonal and pandemic influenza.

The licensure of this facility today is for production of the company's seasonal trivalent influenza vaccine, Fluzone(R), Influenza Virus Vaccine, and augments the current Fluzone vaccine production capacity in the U.S. Sanofi Pasteur invested in the construction of this new $150 million, 140,000 square-foot (13,000 square-meter) vaccine facility as part of its commitment to support public health and to protect individuals against both seasonal and pandemic influenza. The new facility will produce 100 million doses when operating at full capacity.

In total, Sanofi Pasteur will have a capacity of approximately 150 million doses of trivalent seasonal influenza vaccine per year in the U.S. - 50 million doses from the existing facility and 100 million doses from the new facility when it is operating at full capacity. Production of Fluzone vaccine for the 2009-2010 season is already underway in the new facility.

"Sanofi Pasteur is assessing its capabilities to support public health efforts should the WHO and national health authorities request that influenza vaccine manufacturers start supplying vaccine to protect against the new influenza A (H1N1) virus," said Wayne Pisano, President and CEO of sanofi pasteur. "With the licensure of this new influenza vaccine production facility, Sanofi Pasteur now has additional flexibility to produce seasonal influenza vaccine and to respond to requests from public health authorities to develop an A (H1N1) vaccine."

As the world's leading influenza vaccine manufacturer, Sanofi Pasteur produces approximately 40 percent of the influenza vaccines distributed worldwide and in the U.S. produced more than 45 percent of the influenza vaccines distributed for the 2008-2009 influenza season.

Influenza is a highly-contagious respiratory illness with severe health implications that, at times, can lead to death. Influenza viruses spread in respiratory droplets caused by coughing and sneezing. They usually spread from person to person, though sometimes people become infected by touching something with influenza virus on it and then touching their eyes, nose or mouth. Globally, seasonal influenza causes between three and five million cases of severe illness and 250,000 to 500,000 deaths every year. In the U.S. on average each year, one out of five Americans suffers from seasonal influenza, approximately 226,000 are hospitalized, and 36,000 die from seasonal influenza and its complications. The best way to prevent influenza is to get an influenza vaccination.

In the U.S., the Centers for Disease Control and Prevention (CDC) recommends that health-care providers begin offering seasonal influenza vaccine as soon as vaccine becomes available in late August or September, and to continue immunization efforts throughout the season. Health-care providers are urged to continue immunization efforts until the end of influenza season. Approximately 250 million people, or four out of five residents of the U.S., are recommended to receive influenza vaccine annually. The CDC recommends an annual influenza immunization for anyone who wishes to reduce their risk of contracting influenza; children 6 months through 18 years of age; adults 50 years of age and older; pregnant women; and anyone with chronic health conditions, such as asthma, chronic obstructive pulmonary disease (COPD), heart disease, and diabetes. The CDC also recommends annual immunization for caregivers and household contacts of these high-risk groups; such as relatives and health-care providers.

At present there is not yet an influenza vaccine available to prevent influenza caused by the new influenza A (H1N1) virus. Sanofi Pasteur is working closely with the World Health Organization and the CDC to prepare for the development and production of a vaccine that would help prevent against this new influenza A (H1N1) virus. If public health authorities deem it necessary, due to worsening pandemic threat, Sanofi Pasteur is ready to produce a new influenza A (H1N1) vaccine candidate.

Fluzone vaccine is given to persons 6 months of age and older for active immunization against influenza virus types A and B contained in the vaccine. A Fluzone vaccine formulation (trade name: Fluzone, Influenza Virus Vaccine, No Preservative) that does not contain a preservative at any stage in the manufacturing process was introduced in 2004-2005. It is the first FDA-licensed injectable influenza vaccine to be manufactured in this way.

http://www.sanofipasteur.us/ and http://www.fluzone.com