Effective government/industry collaboration bolsters flu vacc...( ated influenza vaccines such as Fluarix...),Health

To determine immune system response to the vaccine, researchers collected serum samples from the study participants both prior to vaccination and 21 days afterward. "The vaccine performed extremely well and very similarly to other influenza vaccines already licensed in the U.S.," notes Dr. Treanor. "It wasn't surprising considering Fluarix is widely used in Europe and has a long safety record there."

Because annual flu shots are generally recommended for adults ages 50 to 64 years old, the researchers analyzed separately the antibody levels of trial participants ages 18 to 49 and those ages 50 to 64 to compare immune responses. While the vaccine was found to produce an immune response in both groups, antibody response rates were higher in the younger study group, particularly those who had no history of flu vaccination within the previous three years.

"This trial provided confirmatory evidence of something we already suspected: that age has an effect on immune response," says Dr. Treanor.

The FDA granted Fluarix licensure under its accelerated approval regulations that allow products designed to treat serious or life-threatening illnesses to be approved based on clinical trial data demonstrating their ability to achieve a specific clinical endpoint that is likely to predict effectiveness--usually one that can be studied more rapidly than showing protection against disease. The Fluarix study demonstrated that after vaccination, study volunteers produced protective antibodies in the blood that the FDA assessed were highly likely to predict effectiveness in preventing flu.

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Contact: Kathy Stover
kstover@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
22-Dec-2005