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The Us Food and Drug Administration said Monday it approved Ixiaro, a vaccine designed to prevent Japanese encephalitis made by Intercell Biomedical Ltd of Livingston, Scotland.
“This vaccine offers protection for individuals who travel to or live in areas where outbreaks are known to occur,” Dr. Karen Midthun, acting director of the FDA’s Center for Biologics Evaluation and Research said.
Japanese encephalitis can be transmitted by the bite of mosquitoes infected with the Japanese encephalitis virus. Mild infection with the virus has as symptoms fever and headache, but it can evolve quickly into a severe infection in which patients can suffer high fever, neck stiffness, stupor, disorientation, coma, tremors, occasional convulsions (especially in infants) and spastic (but rarely flaccid) paralysis.
Japanese encephalitis results in up to 15,000 deaths each year and is considered a potential threat for travelers to Asia. These people have now the opportunity to immunize themselves against the illness by vaccination with Ixiaro. Clinical trials showed that the vaccine is highly immunogenic resulting in protecting antibody titers in 99 percent of subjects following two doses. The immune response was sustained six months.
The vaccine is indicated for active immunization against Japanese encephalitis virus for persons 17 years of age and older. The most common side effects observed in clinical trials with Ixiaro were headache and muscle ache. The most common local reactions were pain and tenderness.
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