The US Food and Drug Administration (FDA) has granted approval to France-based Sanofi Pasteur for its Dengvaxia vaccine intended for the prevention of dengue disease in endemic regions, it was reported yesterday.

The product is said to be the first US FDA-approved vaccine to prevent dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people aged between 9 and 16 years who have laboratory-confirmed previous dengue infection and who live in endemic areas. It is a live and attenuated vaccine, which is administered as three separate injections. Initial dose will be followed by two additional shots at six and 12 months.

Dengvaxia vaccine's safety and effectiveness has been assessed in three randomised and placebo-controlled studies involving around 35,000 individuals in dengue-endemic areas such as Puerto Rico, Latin America and the Asia Pacific region.