FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use

SILVER SPRING, Md., Oct. 19 /PRNewswire-USNewswire/ -- The U.S. Food and Drug
Administration today 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.

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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.

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 today's approval, there are now four companies approved by the FDA to
manufacture seasonal influenza vaccine for use in children.

Influenza is far more dangerous than the common cold for children, who often
require medical care, especially if they are younger than 5 years. It is best
to vaccinate children each fall, 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, it should not be
administered to anyone allergic to eggs or egg products.

Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden, Germany.

For more information:

FDA Web site on Influenza Virus Vaccine Safety and Availability
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm110288.htm

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Peper Long of FDA, +1-301-796-4671, mary.long@fda.hhs.gov