GSK has announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Fluarix Quadrivalent (Influenza Vaccine). This vaccine is currently approved for active immunization against influenza A subtype viruses and type B viruses, in persons three years of age and older. The submission seeks an expanded indication for children six months through 35 months of age. With this approval, providers would be able to use the same dose of Fluarix Quadrivalent (15 ug of hemagglutinin per virus strain in 0.5 mL) to cover all eligible persons from six months and up.

The sBLA application is based on a Phase III pivotal study of the efficacy of Fluarix Quadrivalent in children six months through 35 months of age and on two supportive studies. GSK has submitted the results of the pivotal study to the European Society for Paediatric Infectious Diseases for presentation at their annual meeting on May 23 - 27, 2017, in Madrid.

Seasonal influenza is a contagious respiratory illness, caused by flu viruses. There are two main types of flu viruses, A and B, that spread between people and can cause mild to severe illness. Most flu activity in the US occurs from October-May, and it usually peaks in January and February.

According to the US Centers for Disease Control and Prevention (CDC), the flu is more dangerous than the common cold for children. Severe flu complications are most common in children under the age of 2 years. Each year, many children get sick with seasonal influenza and some of those illnesses result in death. On average, 20,000 children under the age of 5 are hospitalized because of influenza complications. The CDC recommends that everyone aged 6 months and older get a seasonal flu vaccine.