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FDA Approves New Seasonal Influenza Vaccine for Paediatric Use ROCKVILLE, Md -- October 19, 2009 -- The US Food and Drug Administration (FDA) has approved use of a seasonal influenza vaccine (Fluarix) for children aged 3 to 17 years. The vaccine contains inactivated influenza A and B viruses. The safety and effectiveness of the vaccine for use in children aged 3 years and older was documented by a study comparing 2,115 children who received the new vaccine with 1,210 children who received a different influenza vaccine already licensed by the FDA for use in children aged 6 months and older (Fluzone). Study results showed that children aged 3 years and older who received both vaccinations produced similar amounts of antibodies in the blood at levels considered likely to be protective against seasonal influenza. The 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, MD, FDA’s Center for Biologics Evaluation and Research, Rockville, Maryland. “Children are very vulnerable to the influenza virus and are more likely to be hospitalised for associated problems.” Common adverse events experienced after administration of the new vaccine 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 the vaccine contains a small amount of egg protein, it should not be administered to anyone allergic to eggs or egg products. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version