WASHINGTON, Nov 30, 2009 (UPI via COMTEX) -- The U.S. Food and Drug
Administration say it has approved another vaccine to prevent illness caused by
seasonal influenza virus subtypes A and B.
Agriflu, intended for people ages 18 years and older, is manufactured by
Novartis Vaccines and Diagnostics in Siena, Italy. It is administered as a
single injection in a person's 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 Dr. Karen Midthun, acting
director of the FDA's Center for Biologics Evaluation and Research.
The drug 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, the FDA said Novartis demonstrated the
vaccine induced levels of antibodies in the blood likely to be effective in
preventing seasonal influenza. But, 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 that are effective in preventing seasonal
influenza.
The FDA said Agriflu is not intended to protect against the H1N1 influenza
virus.
URL: www.upi.com
Copyright 2009 by United Press International