The US Food and Drug Administration (FDA) Wednesday authorised Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people aged 9-16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.

Dengue is endemic in the US territories of American Samoa, Guam, Puerto Rico and the US Virgin Islands.

The agency granted Dengvaxia's approval to Sanofi Pasteur (EPA:SAN).

The safety and effectiveness of the vaccine was tested 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. The vaccine was determined to be approximately 76% effective in preventing symptomatic, laboratory-confirmed dengue disease in individuals aged 9-16 who previously had laboratory-confirmed dengue disease.

Dengvaxia is a live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots given six and 12 months later. Dengvaxia has already been approved in 19 countries and the EU.