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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

May  1, 2019Approval  FDA Approves Dengvaxia (dengue vaccine) for the Prevention of Dengue Disease in Endemic Regions
Oct 30, 2018FDA Grants Priority Review for Sanofi's Dengue Vaccine Candidate

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.