GSK’s Children’s Flu Vaccine Approved in US

19 October 2009 (Last Updated October 19th, 2009 18:30)

The US Food and Drug Administration (FDA) has approved the use of GlaxoSmithKline's (GSK) Fluarix, a seasonal flu vaccine for children aged three to 17 years. The vaccine, which contains inactivated influenza A and B viruses, had previously only been approved for use in adults aged 18 ye

The US Food and Drug Administration (FDA) has approved the use of GlaxoSmithKline's (GSK) Fluarix, a seasonal flu vaccine for children aged three to 17 years.

The vaccine, which contains inactivated influenza A and B viruses, had previously only been approved for use in adults aged 18 years and older.

FDA Centre for Biologics Evaluation and Research acting director Karen Midthun said that an additional seasonal influenza vaccine would help protect children against influenza.

"Children are very vulnerable to the influenza virus and are more likely to be hospitalised for associated problems," said Midthun.

The safety and effectiveness of Fluarix for use in children was documented by a US study, which compared 2,115 children who received Fluarix with 1,210 children who received Fluzone, a separate licensed flu vaccine for children.

Fluarix is a seasonal influenza vaccine not intended to protect against the 2009 H1N1 influenza virus.