November 28, 2009 | Health & Medicine

FDA Approves Agriflu Seasonal Vaccine

The U.S. Food and Drug Administration cleared Agriflu on Friday to prevent disease caused by the influenza virus subtypes A and B. The vaccine is only approved for people aged 18 and over.

Agriflu was approved using the FDA’s accelerated approval pathway, which helps make medical products for dangerous or life-threatening illnesses become available sooner. Novartis Vaccines and Diagnostics, the makers of Agriflu, demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing the seasonal flu.

Agriflu is administered with a single injection in the upper arm. It is available in single-dose, pre-filled syringes that do not contain preservatives. Common side effects in clinical studies included pain, swelling and redness at the injection site, along with headache and muscle aches. People with severe allergies to chicken eggs should not be vaccinated with Agriflu.

Novartis will conduct further studies on Agriflu as a condition of the accelerated approval. The company also manufactures another licensed seasonal influenza vaccine, Fluvirin, for use in the United States.

AUTHOR: Annette Hulbert