Posted by Michael Wonder on 02 May 2019
First FDA approved vaccine for the prevention of dengue disease in endemic regions
1 May 2019 - The U.S. FDA announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.
Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.
The safety and effectiveness of the vaccine was determined in three randomised, placebo-controlled studies involving approximately 35,000 individuals in dengue-endemic areas, including Puerto Rico, Latin America and the Asia Pacific region.
