FDA Approves Fluarix for Pediatric Use

November 2nd, 2009

The U.S. Food and Drug Administration (FDA) approved, Oct. 19, the use of the seasonal influenza vaccine Fluarix for children ages 3 to 17 years. This vaccine, which contains inactivated (killed) influenza A and B viruses, was previously approved for use in adults, ages 18 years and older.

Fluarix is a seasonal flu vaccine not intended to protect against the 2009 H1N1 flu virus.

“This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” said Karen Midthun, MD, acting director of the FDA’s Center for Biologics Evaluation and Research. “Children are very vulnerable to the influenza virus and are more likely to be hospitalized for associated problems.”

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. 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.

For more information, read the complete FDA press release.


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