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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
May 6, 2009

Media Inquiries:
Peper Long, 301-796-4540
Consumer Inquiries:
888-INFO-FDA


FDA Approves New Influenza Vaccine Production Facility

The U.S. Food and Drug Administration (FDA) today announced that it has approved a new manufacturing facility used to produce influenza virus vaccines.  The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain.

As part of its overall pandemic influenza preparedness efforts, the FDA meets with vaccine manufacturers to guide the efficient establishment of influenza vaccine facilities that comply with agency requirements. The agency promptly reviews applications and manufacturing supplements that could increase both the number of manufacturers and the overall supply of vaccine.

The facility, located in the United States, is owned and operated by sanofi pasteur, which manufactures Fluzone Influenza Virus Vaccine. This new facility will greatly increase sanofi pasteur's production capability.

"This approval represents an important step towards increasing the availability of influenza vaccines," said Karen Midthun, M.D., the FDA's acting director of the Center for Biologics Evaluation and Research.

"Increased manufacturing capacity for influenza vaccine is critical to our preparedness for an influenza pandemic," said Jesse Goodman, M.D., M.P.H., the FDA's acting chief scientist and deputy commissioner for scientific and medical programs. "This action also enhances the ability to produce and provide vaccines to protect the public from seasonal influenza, still estimated to cause more than 30,000 deaths per year. Thanks to strategic investments by the federal government and proactive efforts and engagement by the FDA and the vaccine industry, our nation's preparedness has come a long way over the last five years."

The FDA has interacted with the company throughout the regulatory process to help ensure compliance with applicable requirements.

The bulk manufacturing facility will be used for the production of Fluzone, sanofi pasteur's egg-based influenza vaccine. 

Sanofi Pasteur is located in Swiftwater, Pa.

Information on the FDA's response to the new 2009 H1N1 influenza virus may be found on the FDA's Web site.

Information on seasonal influenza vaccine may be found on the FDA's Web site at http://www.fda.gov/cber/flu/flu.htm.

The FDA's Pandemic Influenza Preparedness Strategic Plan may be found on the FDA's Web site at http://www.fda.gov/oc/op/pandemic/strategicplanupdate03_08.html.

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