GSK announced the submission of a
supplemental Biologics License Application (sBLA) to the U.S. Food and
Drug Administration for FLULAVAL
® QUADRIVALENT (Influenza
Vaccine). This vaccine is currently approved for active immunisation
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 FLULAVAL
® 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 one Phase III pivotal study and
three supportive clinical studies conducted in children six months
through 35 months of age.
FluLaval® Quadrivalent was first
approved in 2013 in the U.S. for the prevention of influenza disease in
people three years of age and older. In addition, it is also approved
in two other countries, Canada (as FluLaval® Tetra) and Mexico (as FluZactal® Tetra),
for the prevention of influenza disease caused by influenza virus types
A and B contained in the vaccine in people six months of age and older.
