ROCKVILLE, Md. -- Afluria was approved today by the FDA as the sixth seasonal influenza vaccine on the U.S. market. Manufactured by Australia's CSL Limited, the company will produce about two million doses for this year's flu season.
ROCKVILLE, Md., Sept. 28 -- Afluria was approved today by the FDA as the sixth seasonal influenza vaccine on the U.S. market.
Manufactured by Australia's CSL Limited, with a U.S. headquarters in King of Prussia, Pa., the company is expected to contribute about two million doses for this year's flu season.
With Afluria counted, an FDA official said about 134 million doses of six vaccines from five different manufacturers should be available for this fall's flu season.
The new approval leaves the U.S. "much better prepared and positioned" to deal with emergencies, such as the 2004 manufacturing failure that left only 63 million doses available, according to Jesse Goodman, M.D., director of the FDA's Center for Biologics Evaluation and Research.
"If problems occur with one manufacturer, we now have a diversity of others to count on," he said at a news conference.
Afluria is an inactivated trivalent vaccine intended to protect adults 18 and older from influenza types A and B. It was given accelerated approval on the basis of tests showing that it produced an antibody response deemed likely to prevent the flu.
Although the company is a new player in the U.S. market, it is "definitely not a new player globally," said Norman Baylor, Ph.D., director of the office of vaccines research and review. Afluria is licensed in 22 other countries, Dr. Baylor said.
Also available in the U.S. are Fluzone, Fluvirin, FluMist, Fluarix, and FluLaval.