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FDA Approves New Influenza Vaccine for Upcoming Flu Season

August 31, 2005 -- ROCKVILLE, MD -- The Food and Drug Administration (FDA) today approved Fluarix, an influenza vaccine for adults that contains inactivated virus. Fluarix is approved to immunize adults 18 years of age and older against influenza virus types A and B contained in the vaccine. Influenza is also commonly called the flu.

"FDA's approval of Fluarix is a big step toward providing an adequate supply of flu vaccine for the American public," said Mike Leavitt, Secretary of Health and Human Services (HHS). "Having more manufacturers of influenza vaccine licensed in the U.S., and having more vaccine dosages, is critical to public health and I applaud FDA for taking such quick action to obtain and evaluate the data needed to license Fluarix in time for this year"s influenza season."

The approval of Fluarix breaks new ground in that it is the first vaccine approved using FDA"s accelerated approval process. Accelerated approval allows products that treat serious or life-threatening illnesses to be approved based on successfully achieving an endpoint that is reasonably likely to predict ultimate clinical benefit, usually one that can be studied more rapidly than showing protection against disease. In this case, the manufacturer demonstrated that after vaccination with Fluarix adults made levels of protective antibodies in the blood that FDA believes are likely to be effective in preventing flu. GlaxoSmithKline, the manufacturer of Fluarix, will do further clinical studies as part of the accelerated approval process to verify the clinical benefit of the vaccine.

"Previous shortages highlighted the need for additional influenza vaccine manufacturers for the U.S. market," said FDA Commissioner Lester Crawford. "Accelerated approval has allowed us to evaluate and approve Fluarix in record time so that we can make available additional safe and effective flu vaccines. I commend our Center for Biologics for taking extraordinary steps to help us be better prepared for both the upcoming and future flu seasons."

This success required close cooperation among the FDA, the National Institutes of Health, and the product manufacturer," said Dr. Jesse Goodman, Director of FDA"s Center for Biologics Evaluation and Research. "The dedicated staff of this Center is doing everything possible to prepare for the upcoming flu season."

FDA based the accelerated approval of Fluarix on thorough evaluation of safety and effectiveness data from four clinical studies involving approximately 1,200 adults. Other data from post-marketing reports in other countries where Fluarix is already approved were also reviewed as part of FDA's safety assessment.

In the United States it is estimated that more than 200,000 people are hospitalized from flu complications, and about 36,000 people die from flu each year. Although no vaccine is 100% effective against preventing disease, vaccination is the best protection against influenza and can prevent many illnesses and deaths.

Fluarix is manufactured in Dresden, Germany by Sächsisches Serumwerk (SSW), a subsidiary of GlaxoSmithKline Biologicals, of Rixensart, Belgium. It will be distributed by GSK in Research Triangle Park, NC.

Source: The Food and Drug Administration

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