High Dose Seasonal Flu Vaccine Approved

(December 25, 2009) - The Food and Drug Administration (FDA) has given the go ahead to a high dose version of the seasonal flu (Read about "Influenza") vaccine that is specifically targeted to people over 65. Fluzone High-Dose is an inactivated influenza virus vaccine 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.

Fluzone High-Dose was approved via the accelerated approval pathway. FDA's accelerated approval pathway helps medical products for serious or life-threatening diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response (Read about "The Immune System") 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.

"As people grow older, their immune systems typically become weaker," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research. "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."