FDA approves Fluarix for use in children, teens

ROCKVILLE, Md. The Food and Drug Administration announced the approval of GlaxoSmithKline’s Fluarix, a seasonal flu vaccine previously approved only for adults, for use in children and teenagers ages 3 years to 17 years. The agency said the approval was based on a clinical trial comparing Fluarix with Sanofi-Aventis’ Fluzone, a vaccine already approved for use in children, which found the two equally effective.

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

The vaccine does not protect against the A-H1N1 swine flu, the agency said.