Dengvaxia is said to be the first FDA-approved vaccine to prevent dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people aged between nine and 16 years who have laboratory-confirmed previous dengue infection and who live in endemic areas.
Dengvaxia 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.
Dengue is endemic in the US territories of American Samoa, Guam and Puerto Rico, as well as the US Virgin Islands.
FDA policy, legislation and international affairs deputy commissioner Anna Abram said: “Dengue disease is the most common mosquito-borne viral disease in the world and global incidence has increased in recent decades.”
As per the estimation of Centers for Disease Control and Prevention (CDC), more than one-third of the world’s population is living in areas at risk for infection by dengue virus that may result in dengue fever, which is a major cause of illness among people in the tropics and subtropics.
Dengvaxia vaccine’s safety and effectiveness has been evaluated in three randomized and placebo-controlled studies involving around 35,000 individuals in dengue-endemic areas such as Puerto Rico, Latin America and the Asia Pacific region.
The vaccine was proved to be around 76% effective in preventing symptomatic, laboratory-confirmed dengue disease in in individuals nine through 16 years of age who previously had laboratory-confirmed dengue disease, said FDA.
Earlier, Dengvaxia vaccine secured approval in countries and the European Union.
Dengvaxia has not received approval for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown.
FDA’s Center for Biologics Evaluation and Research director Dr Peter Marks said: “Infection by one type of dengue virus usually provides immunity against that specific serotype, but a subsequent infection by any of the other three serotypes of the virus increases the risk of developing severe dengue disease, which may lead to hospitalization or even death.”