IXIARO

IXIARO - vaccine to prevent Japanese encephalitis

The U.S. Food and Drug Administration approved IXIARO on March 30, 2009, a vaccine to prevent Japanese encephalitis (JE) which is caused by a mosquito-transmitted virus found mainly in Asia. IXIARO will be the only vaccine for JE available in the United States.

Clinical studies were conducted in more than 800 healthy men and women in the United States and Europe. Participants received either IXIARO or JE-VAX, another U.S.-licensed vaccine that is no longer being manufactured. The studies found that IXIARO produced sufficient levels of antibodies in the blood to protect against JE. IXIARO requires two doses instead of JE-VAX's three.

The vaccine was well tolerated and the most commonly reported adverse events were headache, muscle pain and pain, swelling, and tenderness at the injection site. Overall, it was more tolerable and had fewer side effects than the comparator, JE-VAX.

IXIARO is manufactured by Intercell Biomedical, Livingston, U.K.

Visit : http://www.fda.gov/bbs/topics/NEWS/2009/NEW01981.html