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Seasonal Flu Vaccine Approved for Children

Fluarix sanctioned for kids aged 3 to 17

Please note: This article was published more than one year ago. The facts and conclusions presented may have since changed and may no longer be accurate. And "More information" links may no longer work. Questions about personal health should always be referred to a physician or other health care professional.

TUESDAY, Oct. 20, 2009 (HealthDay News) -- GlaxoSmithKline's seasonal flu vaccine, Fluarix, has been approved by the U.S. Food and Drug Administration for children aged 3 to 17, the agency said in a news release.

The vaccine had been approved for adults 18 and older.

Fluarix contains killed influenza A and B viruses. With the approval, Glaxo is now the fourth company licensed in the United States to produce a vaccine for children against seasonal flu. Fluarix will not protect against the H1N1 swine flu virus, the agency warned.

The vaccine's safety and effectiveness were evaluated in a clinical study of more than 3,300 children that compared Fluarix with Fluzone, an FDA-approved seasonal flu vaccine for children 6 months and older. The two vaccines were about equal in triggering production of blood antibodies that would protect children from seasonal flu, the FDA said.

Common adverse reactions to Fluarix -- including injection-site pain and redness, irritability, loss of appetite and drowsiness -- are typical of many flu shots, the agency said.

More information

Learn more about this approval from the FDA.


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