Dengvaxia FDA Approval History

Last updated by Judith Stewart, BPharm on July 27, 2020.

FDA Approved: Yes (First approved May 1, 2019)
Brand name: Dengvaxia
Generic name: dengue tetravalent vaccine, live
Dosage form: Injection
Company: Sanofi Pasteur, Inc.
Treatment for: Prevention of Dengue Disease

Dengvaxia (dengue tetravalent vaccine, live) is a vaccine indicated for the prevention of dengue caused by dengue virus serotypes 1, 2, 3 and 4 in people 9 years through 16 years of age living in endemic areas who have laboratory-confirmed previous dengue infection.

• Dengue disease is the most common mosquito-borne viral disease in the world. Endemic areas in the U.S. include the territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.
• The first infection with dengue virus typically results in either no symptoms or a mild illness that can be mistaken for the flu or another viral infection. A subsequent infection can lead to severe dengue, including dengue hemorrhagic fever (DHF), a more severe form of the disease that can be fatal.
• Dengvaxia 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. Health care professionals should therefore avoid vaccinating individuals who have not been previously infected by dengue virus.
• Dengvaxia is a 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.
• Commonly reported side effects include headache, muscle pain, joint pain, fatigue, injection site pain and low-grade fever.

Development Timeline for Dengvaxia

Further information

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