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Six flu vaccines approved this year

Posted Monday, September 29, 2008

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The FDA has approved six vaccines for the 2008-2009 flu season. All are for use against influenza disease caused by influenza virus types A and B. They 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 influenza 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. The approval of flu vaccines is a part of FDA’s mission to promote the health of Americans throughout the 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.

According to Jesse Goodman, Director of FDA’s Center for Biologics Evaluation and
Research, yearly immunization is the most effective way to prevent influenza and decrease influenza-related complications.

Assuring the safety of influenza vaccine is one of the agency’s top priorities. So is ensuring that there’s enough vaccine for everyone who wants it—especially for people who are at risk of complications of influenza.

There are two kinds of influenza vaccines:
* The flu shot contains inactivated, or killed, influenza viruses.
* The nasal vaccine is 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.

Each year, according to CDC, an average of 5 to 20 percent of the U.S. population gets the flu. More than 200,000 people are hospitalized from flu complications. There are about 36,000 flu-related deaths each year.

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. For more information visit FDA’s Flu Information Web Site
www.fda.gov/oc/opacom/hottopics/flu.html.

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