FDA approves Fluarix seasonal influenza vaccine for children
The US Food and Drug Administration has approved the seasonal influenza vaccine Fluarix for children aged 3-17. The vaccine, which contains inactivated influenza A and B viruses, had previously been approved only for adults.
The US Food and Drug Administration has approved the seasonal influenza vaccine Fluarix for children aged 3-17. The vaccine, which contains inactivated influenza A and B viruses, had previously been approved only for adults.
The safety and effectiveness of Fluarix for use in children of this age group is documented in a US study comparing 2,115 children who received Fluarix with 1,210 children who were given Fluzone, a different influenza vaccine already licensed by the FDA for use in children aged 6 months and older. The results showed that children vaccinated with Fluarix and Fluzone produced similar amounts of antibodies in the blood at levels considered likely to be protective against seasonal influenza.
Four companies have now received approval by the FDA to manufacture seasonal influenza vaccine for use in children.
Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden, Germany.