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FDA approves Japanese encephalitis vaccine

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The FDA has approved a vaccine to prevent Japanese encephalitis (Ixiaro, Intercell Biomedical), making it the only vaccine available for JE in the United States.

“This vaccine offers protection for individuals who travel to or live in areas where outbreaks are known to occur,” Karen Midthun, MD, acting director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.

In Asia, JE affects about 30,000 to 50,000 people each year, resulting in 10,000 to 15,000 deaths. JE is rarely seen in the United States, with very few cases reported among civilians and military traveling from the United States to Asia. In patients who develop severe disease, JE usually starts as an influenza-like illness but can worsen, causing high fever, neck stiffness, brain damage, coma or death. The disease is transmitted via infected mosquitoes.

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.

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, the vaccine was more tolerable and had fewer side effects than JE-VAX, according to the press release.

Japanese encephalitis is a mosquito-borne infectious disease seen in rural areas of Cambodia, China, India, Japan, Korea, Malaysia, Myanmar, Nepal, Taiwan, Thailand and Vietnam. It is only rarely seen in urban areas. For that reason, the licensure of Japanese encephalitis vaccine will not be important for the majority of international travelers. It will have limited use for persons spending some weeks in rural Asia. Japanese encephalitis is one more infectious disease for which we now have methods for immunological control.

– Herbert L. DuPont, MD

Infectious Disease News Editorial Board member