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 at fda/h1n1flu/default.htm.

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"They are expanding the mandate, but not expanding the pie," Paul Zeitz, executive director of the Global AIDS Alliance, said. He added, "To me, [Obama's proposal] is a betrayal of trust" (New York Times, 5/6). Christine Lubinski, director of the Center for Global Health Policy, said the proposal is "worse than we had feared," adding that Obama has "overlooked the growing threat of tuberculosis."

Irish musician Bono released a statement from his advocacy group ONE, praising the increase in funding. "The question is no longer whether we can fight these diseases in the poorest countries, it is how much do we want to do? The president is answering 'a lot'" (AP/Google, 5/6).

A transcript of the White House briefing is available online.

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