GSK's Influenza Vaccine Gets EU Nod for Expanded Indication

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Fluarix Tetra has been approved for use in children aged six months and above.

GSK announced that its quadrivalent influenza vaccine, Fluarix Tetra, has been approved in Europe for expanded indication to include children from six months of age. The vaccine was previously approved for active immunization against influenza A subtype viruses and type B viruses in people three years of age and older.

Healthcare providers would now be able to administer the same dose of Fluarix Tetra (15 µg of hemagglutinin per virus strain in 0.5 mL) to children from six months of age and older, for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine. Approval of the expanded indication was based on a Phase III pivotal efficacy study of Fluarix Tetra in children six months through 35 months of age and on two supportive studies.

Fluarix Tetra has also been approved to be concomitantly administered with pneumococcal polysaccharide vaccines in people aged 50 years and above.


Source: GSK