GSK receives FDA approval for expanded indication for FluLaval Quadrivalent (influenza vaccine) for infants 6 months and older

GSK

18 November 2016 - GSK announced today it has received approval from the US 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 immunisation 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 pre-filled syringes had to order and stock two separate influenza vaccines to be able to immunise 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.

Read GSK press release

Michael Wonder

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Michael Wonder

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Outcome , US , Vaccine , Paediatrics