The US Food and Drug Administration (FDA) has approved Fluzone, a high-dose inactivated influenza virus vaccine to prevent influenza virus subtypes A and B in people ages 65 years and older.
Fluzone High-Dose, manufactured by Sanofi Pasteur, was approved through the FDA's accelerated approval pathway, which is designed to make much-needed drugs available sooner.
Approval was based on clinical studies, in which 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 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," Midthun said.
As part of the accelerated approval process, Sanofi Pasteur will be required to conduct further studies to verify that Fluzone High-Dose will decrease seasonal influenza disease after vaccination.