First Vaccine Approved for Prevention of Dengue Disease

Global Incidence of Mosquito-Borne Disease Has Increased

The FDA has approved dengue tetravalent vaccine, live (Dengvaxia®, Sanofi Pasteur), for the prevention of dengue disease caused by all dengue virus serotypes (1 through 4) in people aged 9 through 16 years with previous dengue infection who live in endemic areas. Dengue disease is endemic in American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands.

Dengue is the world’s most common mosquito-borne viral disease and global incidence has increased in recent decades. The yellow-fever mosquito, Aedes aegypti, is the main carrier throughout most endemic areas. The Asian tiger mosquito, A. albopictus, is another major carrier of the virus.

More than one-third of the world’s population live in areas at risk for dengue fever, the leading cause of illness among people in tropical and subtropical locations. Around 400 million dengue virus infections occur annually. There are no specific drugs approved to treat the disease, and care is limited to symptom management.

The first infection with the virus typically causes no symptoms or a mild illness that can be mistaken for influenza or another infection. However, a second infection can lead to dengue hemorrhagic fever (DHF), which can be fatal. Each year, an estimated 500,000 cases of DHF cause around 20,000 deaths, mainly among children.

The vaccine’s safety and effectiveness were determined in three randomized, placebo-controlled studies with approximately 35,000 individuals in Puerto Rico, Latin America, and the Asia Pacific region. The vaccine was ≈ 76% effective in preventing symptomatic dengue disease in subjects aged 9 through 16 years who previously had laboratory-confirmed dengue disease.

The most commonly reported side effects were headache, muscle pain, joint pain, fatigue, injection-site pain, and low-grade fever. The frequency of side effects was similar among both dengue tetravalent vaccine and placebo recipients and typically decreased after each subsequent dose.

The FDA granted Dengvaxia priority review and tropical disease priority review designations.  

Source: FDA, May 1, 2019