FDA Approves Sanofi Pasteur’s Fluzone

The FDA has approved Sanofi Pasteur’s Fluzone High-Dose, an inactivated influenza virus vaccine for people aged 65 years and older, to prevent disease caused by influenza virus subtypes A and B.

Fluzone High-Dose is formulated so that each 0.5ml dose contains a total of 180mcg of influenza virus hemagglutinin (HA), which is made up of 60mcg of each of the three influenza virus strains.

Fluzone High-Dose was approved via the accelerated approval pathway. FDA’s accelerated approval pathway helps safe and effective medical products for serious or life-threatening diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone in individuals 65 and older.

As part of the accelerated approval process, the manufacturer is required to conduct further studies to verify that the Fluzone High-Dose will decrease seasonal influenza disease after vaccination.

Karen Midthun, acting director of the Center for Biologics Evaluation and Research at FDA, said: “As people grow older, their immune systems typically become weaker. This is the first influenza vaccine that uses a higher dose to induce a stronger immune response that is intended to better protect the elderly against seasonal influenza.”