FDA Approves 2008-2009 Flu Vaccines

The U.S. Food and Drug Administration (FDA) today announced that 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 http://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.

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and what virus strains 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."

The 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 http://www.fda.gov/cber/flu/flu2008.htm. Of note, two of the three strains recommended for the U.S. this year are now in use for the Southern Hemisphere's 2008 influenza season, which is currently underway.

Each year, experts from the FDA, World Health Organization, U.S. Centers for Disease Control and Prevention (CDC), and other institutions study virus samples and patterns collected throughout the year from around the world 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, the FDA each February decides on the three strains that manufacturers should include in their vaccines for the U.S. population. The FDA makes this decision early in the year so that manufacturers have enough time to produce the new vaccines.

Vaccination remains the cornerstone of preventing influenza, a contagious respiratory illness caused by influenza viruses. According to the CDC, every year an average of 5 to 20 percent of the U.S. population gets the flu, more than 200,000 are hospitalized from flu complications and there are about 36,000 flu-related deaths. Some individuals—the elderly, young children, and people with chronic medical conditions —are at higher risk for flu-related complications. Vaccination of these groups and of health care personnel is critical.

"Currently, only 40 percent of health care workers in the United States are vaccinated against influenza," said Department of Health and Human Services' Assistant Secretary of Health Joxel Garcia, M.D., M.B.A.

"Increasing the number of vaccinated health care personnel can be a strong front in the annual battle against the flu," said Garcia. "Health care workers can set an example for the patients they serve as well as decrease the likelihood of contracting and transmitting the virus."

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FDA News