FDA Approves Dengue Disease Vaccine For Use In U.S. Virgin Islands. The Vaccine, However, Has Limited Use.

The U.S. Food and Drug Administration (FDA) approved the vaccine Dengvaxia on Wednesday, May 1 for the prevention of dengue disease endemic in areas like the U.S. Virgin Islands, European Union and 19 other countries, the V.I. Department of Health has announced.

Dengue is a mosquito-borne virus that, according to the Centers for Disease Control and Prevention (CDC), globally infects approximately 400 million individuals annually. Of these cases, CDC estimates roughly 20,000 deaths occur each year with the large majority of these deaths being children. 

D.O.H. said it is very important to note that there are several serotypes of the dengue virus which include dengue types 1,2,3 and 4. Once you’ve had one type of dengue you are immune only to that type for life. This means you can get dengue up to four times. Those who have been infected before, and are infected with dengue a second, third or fourth time are at higher risk of severe dengue disease. 

The vaccine was tested for effectiveness in three studies where randomized, placebo controlled groups involving about 35,000 individuals in Puerto Rico, Latin America and the Asian Pacific region. The vaccine was determined to be 76 percent effective in preventing symptomatic laboratory-confirmed dengue disease in individuals 9 through 16 years of age who previously had laboratory-confirmed dengue disease.

The vaccine also has several limitations and D.O.H. said it was working to understand these limitations more, along with how the vaccine could potentially work in the territory’s population. For one, the vaccine can only be administered to children age 9-16, and only with previous laboratory evidence of a prior dengue infection. 

“We are excited that the first ever dengue vaccine has been FDA approved, and recognize this achievement in the dengue field. However, we are working diligently within the Department of Health to understand how the vaccine could work for us with its current limitations,” said D.O.H. Acting Commissioner Justa E. Encarnacion. 

The department also said it was working to better understand the appropriateness and expected impact the vaccine could have in reducing dengue in the Virgin Islands, and that it would share information as soon as it is available.