FDA OKs seasonal influenza vaccine Fluarix for pediatric use

The U.S. Food and Drug Administration approved use of the seasonal influenza vaccine Fluarix for children ages 3 to 17.

Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older. Fluarix is a seasonal influenza vaccine not intended to protect against the 2009 H1N1 influenza virus.

"This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” said Karen Midthun, M.D., 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.”

With this approval on Oct. 19, there are now four companies approved by the FDA to manufacture seasonal influenza vaccine for use in children.

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

Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden, Germany.