Dengvaxia is a live attenuated tetravalent chimeric vaccine made using recombinant DNA technology by replacing the PrM (pre-membrane) and E (envelope) structural genes of yellow fever attenuated 17D strain vaccine with those from the four dengue serotypes.
Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4.
Dengvaxia is indicated for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.
It is administered as a Subcutaneous Injection.
Dengvaxia Dosage is currently given as a three-dose series 6 months apart (at month 0, 6, and 12).
Dengvaxia is approved for use in several endemic countries in Latin America and Asia, where reducing the human and economic burden of dengue is critical.
Limitation of Use
Dengvaxia is not 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 the 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.
Blood testing detects the dengue virus or antibodies produced in response to dengue infection.
There are several different types of blood tests that can indicate a dengue infection:
- Molecular tests for dengue virus (PCR)—detect the presence of the virus itself; these tests can diagnose dengue fever up to 7 days after the onset of symptoms and can be used to determine which of the 4 different serotypes of dengue virus is causing the infection.
- Antibody tests, IgM and IgG—detect antibodies produced by the immune system when a person has been exposed to the virus; these tests are most effective when performed at least 4 days after exposure.
- Complete blood count (CBC)—to look for low platelet count typical of the later stages of the illness and to detect the decrease in hemoglobin, hematocrit, and red blood cell (RBC) count (evidence of anemia) that would occur with blood loss associated with severe dengue fever
- Basic metabolic panel (BMP) – to monitor kidney function and look for evidence of dehydration
However, there is no FDA cleared test available to determine a previous dengue infection. Available non-FDA cleared tests may yield false-positive results (e.g., due to cross-reactivity with other flaviviruses).
May 1, 2019: The US Food and Drug Administration (FDA) approved the use of Dengvaxia for children ages 9-16 and is considered a significant medical advance in the prevention of dengue, which is considered an unmet medical need by the FDA.
The European Commission has granted marketing authorization for Dengvaxia, Sanofi’s dengue vaccine. The marketing authorization follows the October 18, 2018, recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to approve the use of the dengue vaccine in European endemic areas.
Dengvaxia will be available in Europe to prevent dengue disease in individuals 9-45 years of age with a documented prior dengue infection and who are living in endemic areas.
“In some of the European overseas territories where dengue recurs regularly, people who have had a dengue infection previously are at risk of being infected with the virus again,” explains Dr. Su-Peing Ng, Global Medical Head at Sanofi Pasteur, the vaccine unit of Sanofi. “As the second infection with dengue tends to be more severe than the first, it is important to be able to offer these people a vaccine that could help protect them against subsequent dengue infections.”