GSK submits application to FDA for expanded indication of influenza vaccine
UK's GlaxoSmithKline (GSK) has submitted a supplemental biologics licence application (sBLA) to the US Food and Drug Administration (FDA) for expanded indication of its influenza vaccine, Fluarix Quadrivalent.
The vaccine currently has approval for active immunisation in individuals aged three and older against influenza A subtype viruses and type B viruses.
The sBLA includes an indication for children aged six months through to 35 months.
The approval will enable the firm to use the same dose of 15ug of haemagglutinin per virus strain in 0.5mL of the vaccine for all eligible people aged six months and older.
The application has been submitted based on a Phase III clinical trial that evaluated the efficacy of the drug in children aged six months through to 35 months, as well as two supportive studies.
The results from the trial were submitted to the European Society for Paediatric Infectious Diseases.
Seasonal influenza is a contagious respiratory illness caused by flu viruses such as influenza A and B.
The vaccine is currently approved in more than 30 other countries worldwide and was initially approved in the US in 2012 for the prevention of influenza disease in people aged three and older.
According to the US Centers for Disease Control and Prevention (CDC), an average of 20,000 children under the age of five are hospitalised due to influenza complications.
Image: GlaxoSmithKline facility. Photo: courtesy of Flickr.