FDA Approves First Dengue Vaccine in the US

The FDA has approved Dengvaxia, the first vaccine approved in the US for the prevention of dengue disease caused by all 4 serotypes of dengue virus in patients aged 9 through 16 years with laboratory-confirmed previous dengue infection.

The vaccine is already approved in 19 other countries and in the European Union.

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The live, attenuated vaccine is administered as 3 injections given at 6-month intervals.

The safety and efficacy of Dengvaxia were examined in 3 randomized, placebo-controlled studies involving approximately 35,000 individuals in dengue-endemic areas. Overall, the researchers found that the vaccine was approximately 76% effective in preventing dengue disease.

The most common side effects reported with Dengvaxia were headache, muscle pain, joint pain, fatigue, injection site pain, and low-grade fever.

The vaccine is not approved for individuals without previous infection with dengue virus, as in these individuals, the vaccine “appears to act like a first dengue infection— without actually infecting the person with wild-type dengue virus–such that a subsequent infection can result in severe dengue disease.”

—Michael Potts

Reference:

First FDA-approved vaccine for the prevention of dengue disease in endemic regions [press release]. May 1, 2019. https://www.fda.gov/news-events/press-announcements/first-fda-approved-vaccine-prevention-dengue-disease-endemic-regions.