December 28, 2009
The Food and Drug Administration (FDA) has approved Fluzone High-Dose to protect people ages 65 years and older against flu virus subtypes A and B. Fluzone High-Dose is an inactivated influenza virus vaccine.
Older people 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, which 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.
"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."
As expected, because it has a higher influenza virus hemagglutinin (HA) content, non-serious adverse events were more frequent after vaccination with Fluzone High-Dose compared with Fluzone. Events experienced during clinical studies included pain, redness and swelling at the injection site and headache, muscle aches, fever and malaise. The rate of serious adverse events was comparable between Fluzone High-Dose and Fluzone.
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, which is manufactured by Sanofi Pasteur Inc., is administered as a single injection in the upper arm and is available in single dose pre-filled syringes without preservative.
