Seasonal Flu Vaccine OK'd for Kids

(October 20, 2009) - A flu vaccine (Read about "Influenza") that had only been available for people over 18 has now been approved for children as young as 3. The U.S. Food and Drug Administration t(FDA) approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.

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 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 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 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, there are now four companies approved by FDA to manufacture seasonal influenza vaccine for use in children.

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, it should not be administered to anyone allergic (Read about "Allergies") to eggs or egg products.