The drug will be able to treat both adults and children from six months of age
GSK announced the expanded indication for Fluarix Tetra (Quadrivalent Influenza Vaccine) has been approved in Europe to include adults and now children from six months of age 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. Fluarix Tetra has also been approved to be concomitantly administered with pneumococcal polysaccharide vaccines in people aged 50 years and above.
Prior to this, the vaccine was approved for active immunisation against influenza A subtype viruses and type B viruses, in people three years of age and older.
Thomas Breuer, Chief Medical Officer, GSK Vaccines said, “Fluarix Tetra can help protect both healthy people and those who are more vulnerable from seasonal influenza and its complications. By expanding our indication for Fluarix Tetra in Europe, we can help ensure parents have the ability to help protect their children even earlier against the flu.”
With this approval, healthcare providers would be able to use the same dose of Fluarix Tetra (15 µg of haemagglutinin per virus strain in 0.5 mL) to cover all eligible people from six months of age and older.
The global disease burden associated with influenza in children under five years of age is substantial. Studies have shown that vaccinating children against influenza may induce herd immunity against influenza for adults aged 65 years and older. 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.