FDA Expands Indication for Fluarix Quadrivalent Flu Vaccine

Megan Brooks

January 12, 2018

The US Food and Drug Administration (FDA) has expanded the indication for the four-strain influenza vaccine Fluarix Quadrivalent (GlaxoSmithKline) to children as young as 6 months.

The FDA first approved Fluarix in 2012 for adults and children aged 3 years and older to help prevent disease caused by the seasonal influenza virus subtypes A and B contained in the vaccine. Fluarix is approved in more than 30 countries worldwide. "With this approval, providers will be able to use the same dose of Fluarix Quadrivalent (15 µg of hemagglutinin per virus strain in 0.5 mL) to cover all eligible persons from 6 months of age and up," GlaxoSmithKline said in a news release

Approval of the supplemental biologics license application for Fluarix in children as young as 6 months of age was based on one phase 3 study and two supportive studies in children aged 6 months through 35 months, the company said.

GlaxoSmithKline's other quadrivalent influenza vaccine (FluLaval) is also approved in the United States for adults and children aged 6 months and older. 

The Centers for Disease Control and Prevention (CDC) recommends that everyone aged 6 months and older get a seasonal influenza vaccine.

Last month, the CDC and global health partners released new estimates suggesting that between 291,000 and 646,000 people die each year globally from seasonal influenza-related respiratory illnesses.  The new estimates are higher than the previous estimate of 250,000 to 500,000 deaths annually.

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