FDA approves another seasonal flu vaccine for children under 17

A seasonal flu vaccine previously only approved for use in persons aged 18 and older has now been given the green light for use in children aged between three and 17, the FDA announced on Monday.

WASHINGTON - The FDA has approved a seasonal flu vaccine for use in children aged between 3 to 17 that had previously been used only for persons over 18. 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 FDA said in a news release on Monday. The approval adds to the number of companies approved by the FDA to manufacture seasonal flu vaccine for children. Fluarix is manufactured by GlaxoSmithKline of Dresden, Germany. Fluarix was approved for use after a study involving 2,115 children and was found to be safe and effective. Another vaccine, Fluzone, is already approved for use in children aged six months and older. Both vaccines produced similar amounts of antibodies considered likely to protect children who are more vulnerable to the effects of seasonal flu. The vaccine is not meant for use for the current Pandemic H1N1 virus also known as Swine Flu. "This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” said Karen Midthun, FDA's acting director for biological evaluations. “Children are very vulnerable to the influenza virus and are more likely to be hospitalized for associated problems," she said. Influenza is far more dangerous than the common cold for children, who often require medical care, especially if they are younger than 5 years, she said. " It is best to vaccinate children each fall, but vaccination also can occur in the winter months when influenza season often peaks," she said. Fluarix contains a small amount egg protein so it is not to be administered to children allergic to eggs or egg products.