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FDA Expands Flu Vaccine Indication
Posted by: admin in Pharmacy Drugs on July 27th, 2010
WASHINGTON — The FDA has expanded approval of GlaxoSmithKline ’s seasonal flu vaccine (Fluarix) to children 3 to 17 years old.
Previously, the vaccine had been approved for adults only.
The expanded indication is based on efficacy data from a U.S. study comparing 2,115 children who received the vaccine with 1,210 children who received a different flu vaccine, Fluzone, for children 6 months and older.
The study found children 3 and older produced antibody levels considered protective against seasonal flu.
The Fluarix vaccine contains egg protein and should not be taken by anyone allergic to egg or egg products, the FDA said.
Common side effects of Fluarix include pain, redness, and swelling of injection site, irritability, loss of appetite, and drowsiness.
The FDA and other health organizations strongly recommend vaccination against seasonal flu, which kills 36,000 people annually and hospitalizes nearly 200,000. (See Early Vaccination for Seasonal Flu Recommended)
The flu is far more dangerous in children than colds, as infection can often lead to hospitalization. It is recommended children get vaccinated in the fall or winter before or during the flu season’s peak.
This drug is not designed to protect against pandemic H1N1 swine flu, which requires a separate vaccine.
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