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FDA APPROVES INFLUENZA VACCINES FOR UPCOMING FLU SEASON

August 3, 2006

The FDA has approved this year's seasonal influenza vaccines that include the new strains of virus judged likely to cause flu in the Northern Hemisphere in 20062007.

Each year influenza vaccine manufacturers submit information and samples to FDA of their virus strains being manufactured for the upcoming seasonal influenza season. Because different influenza virus strains may appear each year, one or more of the strains in the vaccine may need to be changed to protect against what public health experts think are the strains most likely to infect people that year. This season's approved formulation for the U.S. vaccine is identical to that recommended by both the World Health Organization and FDA's advisory committee. The formulation includes one strain that was used in last year's vaccine and two new strains. Seasonal flu vaccines do not protect against avian flu, which is caused by different viral strains.

Four vaccine manufacturers won approval to market their vaccines in the United States: Chiron Vaccines, GlaxoSmithKline, MedImmune and sanofi Pasteur. The manufacturers are projected to make approximately 100 million doses of vaccine.