Seasonal Influenza Vaccine Fluarix Approved for Kids

The FDA has approved the use of seasonal influenza vaccine Fluarix for children ages 3 to 17.
Previously, the vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults ages 18 and older.

The safety and effectiveness of Fluarix for children ages 3 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.

Fluarix does not 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, 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."

With today's approval, four companies now have FDA approval to make seasonal influenza vaccine for children.

Influenza is far more dangerous than the common cold for children, who often require medical care, especially if they are younger than 5. Vaccinating children each fall is best, but vaccination also can occur in the winter months when influenza season often peaks.

Common adverse events experienced after administration of Fluarix are typical of those for flu shots and include pain, redness and swelling at the injection site, as well as irritability, loss of appetite and drowsiness.

Because Fluarix contains a small amount of egg protein, anyone allergic to eggs or egg products shoud not receive it.

Fluarix is manufactured by GlaxoSmithKline Biologicals.

Contact:
Peper Long
301-796-4671
mary.long@fda.hhs.gov