FDA Approves Six 2008-2009 Flu Vaccines

The U.S. Food and Drug Administration yesterday announced it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season.

The six vaccines and their manufacturers are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone. Approval information and specific indications can be found at www.fda.gov/cber/flu/flu2008.htm.

This season's vaccines contain three strains of the influenza virus that disease experts expect to be the most likely cause of the flu in the United States. Each season's vaccines are modified to reflect the virus strains most likely to be circulating. The closer the match between the circulating strains and the strains in the vaccines, the better the protection.

FDA says there is always a possibility of a less-than-optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. Even if the vaccines and the circulating strains are not an exact match, they will provide some protection and may reduce the severity of the illness or prevent flu-related complications. "One of the biggest challenges in the fight against influenza is producing new vaccines every year," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "There is no other instance where new vaccines must be made every year. The approval of flu vaccines is a part of FDA's mission to promote the health of Americans throughout the year."

FDA changed all three strains for this year's influenza vaccine--an unusual occurrence, as usually only one or two strains are updated from year to year. A list of the strains included in the 2008-2009 vaccine can be found at www.fda.gov/cber/flu/flu2008.htm.

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