Dengvaxia FDA Approval History

Last updated by Judith Stewart, BPharm on July 24, 2023.

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 disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

• 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.
• Limitations of use:
  - Dengvaxia is not approved for use in individuals younger than 6 years of age. These individuals, regardless of previous infection by dengue virus, are at increased risk of severe and hospitalized dengue disease following vaccination with Dengvaxia and subsequent infection with any dengue virus serotype.
  - Dengvaxia is not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. Those not previously infected are at increased risk for severe dengue disease when vaccinated and subsequently infected with dengue virus. Previous dengue infection can be assessed through a medical record of a previous laboratory-confirmed dengue infection or through serological testing prior to vaccination.
  - The safety and effectiveness of Dengvaxia have not been established in individuals living in dengue nonendemic areas who travel to dengue endemic areas.
• 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.
• Common adverse reactions regardless of the dengue serostatus prior to vaccination in ages 9 through 16 years include headache, injection site pain, malaise, asthenia, and myalgia.
  Common adverse reactions regardless of the dengue serostatus prior to vaccination in ages 6 through 8 years include headache, injection site pain, malaise, asthenia, and myalgia.

^{Reference:
Dengvaxia. Prescribing information. Sanofi Pasteur, Inc. 2023 https://www.fda.gov/media/124379/download Accessed July 24, 2023}

Development timeline for Dengvaxia

Further information

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