FDA Approves Agriflu Seasonal Influenza Vaccine

November 30, 2009

The US Food and Drug Administration has approved Agriflu, a new seasonal flu vaccine manufactured by Novartis Vaccines and Diagnostics (Siena, Italy), for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

The US Food and Drug Administration has approved Agriflu, a new seasonal flu vaccine manufactured by Novartis Vaccines and Diagnostics (Siena, Italy), for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

Agriflu was approved using the FDA’s accelerated approval pathway, which helps safe and effective medical products for life-threatening diseases become available sooner. Novartis demonstrated that Agriflu induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.

The approval of the new seasonal influenza vaccine, Agriflu, is an important step in adding to the production capacity to enhance the supply of vaccine for the US for future influenza seasons,” said Karen Midthun, acting director of the FDA’s Center for Biologics Evaluation and Research.

As part of the accelerated approval process, Novartis is required to conduct further studies to verify that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza.

The FDA approved six other vaccines before the flu season began this year. The six vaccine brand names and manufacturers include Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Limited; Fluzone, Sanofi Pasteur Inc.; and FluMist, MedImmune Vaccines Inc.