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Vaccines Ready for Flu Season

Six new additions to approved list

September 29, 2008

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With the flu season approaching, the Food and Drug Administration (FDA) is announcing six vaccines have been approved for the 2008-2009 flu season. All are for use against influenza disease caused by influenza virus types A and B.

Commonly called "the flu," influenza is a virus-induced, contagious respiratory illness.

There are two kinds of influenza vaccines:

The flu shot, which contains inactivated, or killed, influenza viruses.

The nasal vaccine, known by the trade name of FluMist. It contains weakened, live viruses, and is sprayed into both nostrils.

Autumn is the best time to get vaccinated, although getting the vaccine in the winter months when flu season often peaks is also recommended. The six vaccines approved for this season are:

• Afluria, for adults 18 years of age and older

• Fluarix, for adults 18 years of age and older

• FluLaval, for adults 18 years of age and older

• Fluvirin, for people 4 years of age and older

• Fluzone, for people 6 months of age and older

• FluMist, for people ages 2 to 49

Manufacturers of the six vaccines project about 146 million doses will be available for this flu season, according to the U.S. Centers for Disease Control and Prevention.

"One of the biggest challenges in the fight against influenza is producing new vaccines every year," says 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."

Experts from FDA, CDC, the World Health Organization, and other institutions annually study virus samples and disease patterns collected worldwide in an effort to identify strains that may cause the most illness in the upcoming season.

Based on those forecasts and on the recommendations of its Advisory Committee, FDA each February decides on the three strains that manufacturers should include in their vaccines for the U.S. population. Each season's vaccines are modified to reflect the virus strains most likely to be circulating and cause the flu.

In an unusual occurrence, FDA changed all three strains for this year's influenza vaccine. Usually, only one or two strains are updated from year to year.

This year's vaccines include the following strains:

• an A/Brisbane/59/2007 (H1N1)-like virus

• an A/Brisbane/10/2007 (H3N2)-like virus

• a B/Florida/4/2006-like virus

The approach of flu season also serves to remind health care workers to get vaccinated against influenza. The U.S. Department of Health and Human Services (HHS) recently launched an initiative to help improve vaccination rates among health care personnel.

Flu shots should be considered a part of patient safety. Studies have shown that only about 4 in 10 health care professionals are vaccinated every year. Those that don't get vaccinated can cause influenza outbreaks in health care settings.

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