Agriflu Seasonal Influenza Vaccine Gets FDA Approval

The FDA has approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

Agriflu, manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, was approved using the FDA’s accelerated approval pathway, which helps safe and effective medical products for serious or life-threatening diseases become available sooner. In this case, Novartis has demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.

The company said that Agriflu is administered as a single injection in the upper arm and is available in single dose, pre-filled syringes that do not contain preservatives.

Reportedly, 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 company also manufactures another licensed seasonal influenza vaccine, Fluvirin, for use in the US. Fluvirinis approved for people ages 4 years and older. Agriflu is not intended to protect against the 2009 H1N1 influenza.

Karen Midthun, acting director of the center for biologics evaluation and research at FDA, said: “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 United States for future influenza seasons.”