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INFLUENZA

New Flu Shot Approved For This Year's Season

POSTED: 9:33 am PDT August 31, 2005

The government is clearing the way for more flu vaccine to be available this year, following last year's unexpected shortage.

The Food and Drug Administration Wednesday approved Fluarix, a new flu shot made in Germany by a subsidiary of GlaxoSmithKline. Glaxo has supplied flu vaccine for other countries in the past.

Fluarix is approved for use in adults 18 and older.

"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," said Mike Leavitt, secretary of Health and Human Services.

Last year's shortage came about when British regulators shut down a U.S. supplier after they found contaminated vaccine. That company, Chiron Corp., said it has passed an inspection of its factory in Britain. That's a step toward regaining FDA approval to sell flu shots in the United States.

There are more steps ahead for the company, and there's no guarantee they will be completed by this fall.

"We are pleased that the Chiron Corporation has taken steps to address issues at their facility in Liverpool as they prepare for the upcoming flu season," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research. "However, additional work is needed to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season."

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