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FDA approves vaccines for upcoming flu season

Pharmacy Regulation Resource, August 11, 2006

The Food and Drug Administration (FDA) has approved this year's seasonal influenza vaccines, which include the new strains of virus that health officials believe will cause flu in the Northern Hemisphere in 2006-2007.

Vaccine manufacturers submit information and samples each year to the FDA of the virus strains being made for the upcoming season. One or more of the strains may need to be changed to protect against the strains that public health experts believe are most likely to infect people this year.

This season's approved vaccine formulation matches the one recommend by the World Health Organization and the FDA's Advisory Committee. The formula 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 strains.

There are four vaccine manufacturers with approval to market their vaccines in the U.S.: Chiron Vaccines, Ltd.; GlaxoSmithKline Biologicals; MedImmune Vaccines, Inc.; and Sanofi Pasteur, Inc. They have projected the production of about 100 million doses of flu vaccine for 2006-2007 season, but the projections could change as manufacturing continues.