The dengue vaccine Dengvaxia has been approved by the U.S. Food and Drug Administration for use in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands, but it’s use is limited to people aged 9 to 16.

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The vaccine has already been approved in 19 countries and the European Union.

Dengvaxia is not approved for use in people not previously infected by dengue virus. In these people, Dengvaxia acts like a first dengue infection and a subsequent infection can result in severe dengue disease, according to the FDA.

Dengue disease is the most common mosquito-borne viral disease in the world. About 400 million dengue infections occur worldwide each year, leading to about 20,000 deaths, primarily among children, according to the U.S. Centers for Disease Control and Prevention.

Dengue cases are rare in the continental U.S., but the disease is regularly found in American Samoa, Puerto Rico, Guam, the U.S. Virgin Islands, as well as Latin America, Southeast Asia and the Pacific islands, the FDA said.

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