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FDA OK's pediatric seasonal flu vaccine
Tuesday, October 20, 2009 9:18 AM


The FDA said Fluarix, which contains inactivated influenza A and B viruses, had previously been approved for use in adults. The drug is a seasonal influenza vaccine and is not intended to protect against the 2009 H1N1 flu virus, officials said.

"The safety and effectiveness of Fluarix for use in children ages 3 years and older is documented by a U.S. study comparing 2,115 children who received Fluarix with 1,210 children who received Fluzone, a different influenza vaccine already licensed by the FDA for use in children ages 6 months and older," the FDA said. "Study results showed that children 3 years and older vaccinated with Fluarix and Fluzone produced similar amounts of antibodies in the blood at levels considered likely to be protective against seasonal influenza."

Because Fluarix contains a small amount of egg protein, it should not be administered to anyone allergic to eggs or egg products, officials said.

Fluarix is manufactured by GlaxoSmithKline (NYSE:GSK) Biologicals of Dresden, Germany.

(Source: UPI )


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