New Flu Vaccine Approved for Adults

The FDA has approved a new influenza vaccine, FluLaval, for adults 18 and older. FluLaval's manufacturer, GlaxoSmithKline, says it will begin shipping the vaccine immediately.

The vaccine has been available in Canada since 2001. It was approved in the U.S. under a fast-track review. During this process, the FDA reviewed data from randomized, controlled trials comprising over 1600 participants. The studies showed that FluLaval is safe and stimulates an immune response, according to the manufacturer; there have been no controlled trials showing that use of the vaccine decreases influenza disease.

An inactivated virus vaccine, FluLaval is packaged in a multi-dose vial with the preservative thimerosal. It should not be given to anyone with known hypersensitivity reactions to egg or chicken proteins, or with a history of life-threatening reaction to any flu vaccine, or with an acute evolving neurologic disorder.

The approval means there are now five vaccines licensed for use in the U.S.; according to the CDC there will be a total of some 115 million doses available for the upcoming influenza season.