FDA Approves Japanese Encephalitis Vaccine

The U.S. Food and Drug Administration (FDA) approved, March 30, a new vaccine to prevent Japanese encephalitis virus (JEV). IXIARO®, manufactured by Austrian drug maker Intercell AG, is the only vaccine for JEV in the United States.

Japanese encephalitis is a mosquito-transmitted virus prevailing in Asia. Mild infections can occur without apparent symptoms other than fever and headache, but an acute case can lead to paralysis, seizures, coma, and even death. In Asia, JEV strikes some 30,000 to 50,000 individuals a year, causing 10,000 to 15,000 deaths annually. Less than one case per year, however, occurs in U.S. civilians and military personnel traveling to and living in Asia.

The vaccine is intended for ages 17 years and older. Immunization consists of two 0.5 mL doses administered 28 days apart, to be completed at least one week prior to potential exposure.

The FDA approval pending indicator has been removed from the new CPT® code 90738 Japanese encephalitis virus vaccine, inactivated, for intramuscular use.

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