(dailyRx)

The FDA has approved Fluzone High-Dose, an inactivated influenza virus vaccine for people age 65 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'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, Sanofi Pasteur, is required to conduct further studies to verify that Fluzone High-Dose decreases seasonal influenza disease after vaccination. Sanofi Pasteur also makes Fluzone, a seasonal approved for use in individuals ages 6 months and older.

"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."

Fluzone High-Dose is formulated so each 0.5 mL dose contains a total of 180 mcg of influenza virus hemagglutinin (HA), which 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 mcg of influenza virus hemagglutinin (15 mcg HA from each of the three influenza strains per dose).

Because of the higher HA content, nonserious adverse events were more frequent after vaccination with Fluzone High-Dose compared with Fluzone, as expected. Common adverse 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.

Contact:
Shelly Burgess
301-796-4651
shelly.burgess@fda.hhs.gov