FDA approves Dengvaxia for dengue prevention in people ages 9-16

The U.S. Food and Drug Administration approved Dengvaxia for the prevention of dengue disease caused by serotypes 1 – 4 of the virus in individuals 9 through 16 years of age living in endemic areas of the U.S. with a laboratory-documented prior infection. Dengvaxia is the first and only vaccine approved for protection against dengue in endemic areas of the U.S. Dengvaxia is also approved for use in several endemic countries in Latin America and Asia where reducing the human and economic burden of dengue is a public health priority. In December 2018, the European Commission granted marketing authorization for Dengvaxia to prevent dengue in individuals living in endemic areas with a documented prior infection. “Dengue is endemic and prone to outbreaks in several U.S. territories, including Puerto Rico, the U.S. Virgin Islands and American Samoa. Despite this public health threat, there is no treatment and there has been no previously approved vaccine available in these areas,” said David Greenberg, MD, Regional Medical Head North America, Sanofi Pasteur. “Today’s FDA approval of Dengvaxia allows us to bring a critical medical prevention tool to at-risk populations, helping combat and prevent dengue among children living in U.S. dengue endemic areas.”
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