Flu vaccine expanded for use in young children.
GlaxoSmithKline announced it has received approval from the FDA Center for Biologics Evaluation and Research expanding the indication for Fluarix Quadrivalent (Influenza Vaccine) to include use in persons 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.
The supplemental Biologics License Application was based on a Phase III pivotal study of the efficacy of Fluarix Quadrivalent in children 6 months through 35 months of age and on two supportive studies. It is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
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