FDA approves a high dose flu influenza vaccine intended for seniors

SILVER SPRING, Md. — The U.S. Food and Drug Administration approved 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.

Fluzone High-Dose was approved via the accelerated approval pathway, the FDA announced Dec. 23. Its accelerated approval pathway helps products for serious or life-threatening diseases become available sooner. The manufacturer is required to conduct further studies to verify that the Fluzone High-Dose will decrease seasonal influenza disease after vaccination.

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

"As people grow older, their immune systems typically become weaker," said Karen Midthun, 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."

People with hypersensitivity to egg proteins or life-threatening reactions after previous administration of any influenza vaccine should not be vaccinated with Fluzone High-Dose.

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