U.S. Food and Drug Administration announced 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.
Under the proprietary name of Dengvaxia manufactured by Sanofi Pasteur Inc. It will be supplied in a single dose, which contains one vial of lyophilized vaccine antigen and one vial of saline diluents. It needs to be stored at a temperature of 2°C to 8°C. It is live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots given six and twelve months later.
Each year, an estimated 400-million dengue virus infections occur globally according to the CDC. Of these, approximately 500,000 cases develop into DHF, which contributes to about 20,000 deaths, primarily among children.
The FDA granted this application Priority Review and a Tropical Disease Priority Review Voucher under a program intended to encourage the development of new drugs and biologics for the prevention and treatment of certain tropical diseases.
In a press release, Anna Abram, FDA deputy commissioner for policy, legislation, and international affairs said, “Dengue disease is the most common mosquito-borne viral disease in the world and global incidence has increased in recent decades”
The safety and effectiveness of the vaccine was determined in three randomized, placebo-controlled studies involving approximately 35,000 individuals in dengue-endemic areas, including Puerto Rico, Latin America and the Asia Pacific region.
Dengvaxia has already received its approval in Europe in Oct, 2018 and also approved in Latin America, Asia and 19 other countries.