On Aug. 16, 2013, GSK announced it had received approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research expanding the indication for FluLaval^® Quadrivalent (Influenza Vaccine) to include use in children 6 months and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in persons 3 years of age and older.

Before the approval of an expanded age indication for FluLaval^® Quadrivalent, providers who preferred prefilled syringes had to order and stock two separate influenza vaccines to be able to immunize all patients. With this approval, providers are now able to use the same dose of FluLaval^® Quadrivalent (15ug of hemagglutinin per virus strain in 0.5 mL) to vaccinate all recommended persons aged 6 months and older.

The supplemental Biologics License Application was based on one Phase III pivotal study and three supportive clinical studies conducted in children 6 months through 35 months of age.