Agriflu Flu Vaccine Earns Approval

The FDA has approved Agriflu for people ages 18 and older to prevent disease caused by influenza virus subtypes A and B. 
Agriflu, manufactured by Novartis Vaccines and Diagnostics, 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 demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.

Agriflu is not intended to protect against the 2009 H1N1 influenza.

The vaccine is administered as a single injection in the upper arm and is available in single dose, prefilled syringes that do not contain preservatives.

"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," said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research.

Common side effects in clinical studies included pain, swelling and redness at the injection site, headache, muscle aches and malaise. People with severe or life-threatening allergies to chicken eggs or to any other substance in the vaccine should not be vaccinated.

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

More information is available on the FDA's Webpage on 2009–2010 seasonal flu vaccines at
www.fda.gov/ForConsumers/ConsumerUpdates/ucm100139.htm.

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