New Flu Vaccine Approved

FDA Approves New Influenza Vaccine for Upcoming Flu Season

The Food and Drug Administration (FDA) today approved Fluarix, an influenza vaccine for adults that contains inactivated virus. Fluarix is approved to immunize adults 18 years of age and older against influenza virus types A and B contained in the vaccine. Influenza is also commonly called the flu.

"FDA"s approval of Fluarix is a big step toward providing an adequate supply of flu vaccine for the American public," said Mike Leavitt, Secretary of Health and Human Services (HHS). "Having more manufacturers of influenza vaccine licensed in the U.S., and having more vaccine dosages, is critical to public health and I applaud FDA for taking such quick action to obtain and evaluate the data needed to license Fluarix in time for this year"s influenza season."

The approval of Fluarix breaks new ground in that it is the first vaccine approved using FDA"s accelerated approval process. Accelerated approval allows products that treat serious or life-threatening illnesses to be approved based on successfully achieving an endpoint that is reasonably likely to predict ultimate clinical benefit, usually one that can be studied more rapidly than showing protection against disease. In this case, the manufacturer demonstrated that after vaccination with Fluarix adults made levels of protective antibodies in the blood that FDA believes are likely to be effective in preventing flu. GlaxoSmithKline, the manufacturer of Fluarix, will do further clinical studies as part of the accelerated approval process to verify the clinical benefit of the vaccine.