Dengvaxia Approval History

Reviewed by J.Stewart BPharm Last updated on May 7, 2019.

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 History and FDA Approval Process for Dengvaxia

Date	Article
May  1, 2019	FDA Approves Dengvaxia (dengue vaccine) for the Prevention of Dengue Disease in Endemic Regions
Oct 30, 2018	FDA Grants Priority Review for Sanofi's Dengue Vaccine Candidate
Sep  7, 2016	Takeda Initiates Global Phase 3 Clinical Trial (TIDES) of Dengue Vaccine Candidate (TAK-003)
Aug  5, 2013	SIGA Selects Lead Candidate for Dengue Antiviral Program
Dec  7, 2011	Inviragen Presents Safety and Immune Response Data from a Phase 1 Study of its Two-Dose Dengue Vaccine, DENVax
Dec 21, 2010	NanoViricides Announces That The Company Has Been Invited To Present at Dengue Research Meeting Sponsored by the National Institutes of Health
Jun 21, 2010	Anti-Dengue Nanoviricides Achieve Significant Protection in Initial In Vivo Studies on Dengue Hemorrhagic Fever
Jul 27, 2009	Inovio Biomedical Universal Dengue DNA Vaccine Demonstrates Strong Immune Responses Against All Four Serotypes
Oct 20, 2008	NanoViricides, Inc. Participated In WHO Meeting On Dengue Therapeutics
Nov  6, 2007	Sanofi Pasteur Presents Positive Results of Tetravalent Dengue Candidate Vaccine

Further information

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