FDA approves Agriflu
SILVER SPRING, Md. Another flu vaccine has been approved by the Food and Drug Administration.
The FDA announced the approval of Agriflu for adults ages 18 years and older to prevent disease caused by influenza virus subtypes A and B. It is not intended, however, to protect against the 2009 H1N1 influenza.
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 demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.
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.
"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, M.D., 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 company also manufactures another licensed seasonal influenza vaccine, Fluvirin, for use in the United States. Fluvirin is approved for people ages 4 years and older.