GlaxoSmithKline Seeks FDA Approval for Flu Vaccine

The company's Fluarix could become the fourth flu vaccine available for the U.S. market.
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GlaxoSmithKline

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said Wednesday that it has sought federal government approval for its flu vaccine.

If the Food and Drug Administration approves the product promptly, the company's Fluarix would become the fourth flu vaccine available for the U.S. market for the upcoming flu season.

In recent years, the U.S. flu vaccine market has been characterized by uncertain demand and even more uncertain supply. Last October,

Chiron

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, which had been expected to provide about half of the U.S. supply, said problems at a plant in Great Britain would prevent it from supplying any vaccine during the U.S. flu season.

Chiron has since received clearance from British regulators to resume production, but the FDA still needs to give its approval before endorsing the company's vaccine for the upcoming season. The FDA is supposed to conduct its review between mid-June and mid-July.

Chiron has predicted that it could provide 25 million to 30 million doses for the U.S. market, down from the roughly 50 million doses federal health officials had expected for the 2004-2005 season.

GlaxoSmithKline, which sells Fluarix in more than 75 countries, provided a small amount of flu vaccine to the U.S. on an emergency basis during the previous flu season.

"Right now a limited number of companies supply injectable flu vaccine to the entire nation, making the system vulnerable when there are problems with supply as we saw last flu season," said Christopher Viehbacher, GlaxoSmithKline's president of U.S. Pharmaceuticals, in a prepared statement Wednesday.

"We're happy to be once again working closely with the Department of Health and Human Services and the FDA to help fill this void in public health, and with FDA approval, we're committed to making Fluarix available before the next flu season," he added.

The company didn't say how much vaccine it would make. It provided 1.2 million doses last year. Recently, Standard & Poor's said the company could make as much as 10 million doses for the upcoming flu season.

The biggest provider for the U.S. will still be

Sanofi-Aventis

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, which could deliver up to 60 million doses.

MedImmune

(MEDI)

, developer of the nasal spray FluMist, is expected to make about 3 million doses.