FDA Approves Sanofi's High Dose Flu Vaccine for People Older Than 65

January 15, 2010

The US Food and Drug Administration has approved Sanofi Pasteur's Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older, to prevent disease caused by influenza virus subtypes A and B.

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

People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.

In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone in individuals 65 and older.

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

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

Other currently licensed seasonal influenza vaccines for adults are formulated to contain a total of 45 µg of influenza virus hemagglutinin (15 µg HA from each of the three influenza strains per dose). Sanofi Pasteur also manufactures Fluzone, a seasonal vaccine for the US approved for use in individuals ages six months and older.

Fluzone High-Dose is administered as a single injection in the upper arm and is available in single dose prefilled syringes without preservative.