GSK's Influenza Vaccine Receives FDA Approval for Expanded Indication

GlaxoSmithKline announced it received approval from the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research to expand the indication for Fluarix Quadrivalent (influenza vaccine) to include use in those 6 months and older.

Before the expanded indication, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses in those 3 years and older.

“The flu vaccine is the one vaccine that people of almost all ages — from 6-month old infants to older adults — should receive annually,” Patrick Desbiens, senior vice president, US Vaccines, said in a statement. “We can now offer 2 flu vaccines that enable providers to use the same vaccine dose to help protect all recommended persons aged 6 months and older against this potentially serious illness.”

The supplemental biologics license application submitted in March 2017, was based on a phase III pivotal study of the efficacy of Fluarix Quadrivalent in children 6 through 35 months of age and 2 supportive studies.

First approved in 2012 for the prevention of influenza in those 3 years of age and older, providers can now use Fluarix Quadrivalent 15 ug of hemagglutinin per virus strain in 0.5 mL to cover all eligible persons from 6 months of age and older.

Fluarix Quadrivalent is indicated for active immunization in the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

The most common solicited adverse effect reaction in adults was pain, while the most common systemic adverse effects in adults were muscle aches, headaches and fatigue.

In children aged 6 through 35 months, the most common solicited adverse effects were pain and redness, and the most common systemic adverse reactions were irritability, loss of appetite and drowsiness.

Common solicited adverse effects in children 3—17 years of age included pain, redness and swelling. In those 3–5 years of age, the most common systemic adverse effects included drowsiness, irritability and loss of appetite.

Children aged 6—17 years old reported fatigue, muscle aches, headache, arthralgia and gastrointestinal symptoms as the most common systemic adverse effects.

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