October 5, 2006 -- One More Flu Vaccine Is Approved

The Centers for Disease Control and Prevention (CDC) announced today that an additional flu vaccine has been approved for use this year, bringing to five the number of FDA-licensed vaccines in the United States for the upcoming flu season. The latest vaccine, called FluLaval, is approved only for persons 18 years of age and older and has not been tested for use in children or pregnant women. The CDC said the vaccine was approved after clinical studies involving 1,000 adults and reviews of data from Canada, where the vaccine has been in use since 2001. The CDC noted that FluLaval was approved using a new accelerated pathway that allows the agency to approve products for serious or life-threatening diseases based on early evidence of effectiveness. As part of the accelerated process, the manufacturer, in this case a Canadian subsidiary of GlaxoSmithKline, will conduct further studies after the vaccine becomes available. FluLaval is administered as a single injection in the upper arm. In its current formulation, the vaccine is packaged in a multi-dose vial with thimerosal, a mercury derivative, as a preservative.