Dengvaxia (dengue tetravalent vaccine, live)

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. Dengvaxia is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

Limitations of use

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 non-endemic areas who travel to dengue endemic areas.

Warnings and precautions

Increased Risk of Severe Dengue Disease Following Dengvaxia in Persons not Previously Infected with Dengue Virus

In unvaccinated individuals, first dengue infections rarely cause severe dengue, while second dengue infections with a different serotype are associated with an increased risk of severe dengue.

Dengvaxia administration to individuals not previously infected by dengue virus is associated with an increased risk of severe dengue disease when the vaccinated individual is subsequently infected with any dengue virus serotype. Therefore, healthcare professionals must evaluate individuals for prior dengue infection to avoid vaccinating individuals who have not been previously infected by dengue virus.

Previous infection by dengue virus can be evaluated through a medical record of previous laboratory-confirmed dengue infection or through serotesting prior to vaccination. 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).

Other Side Effects

Nonserious adverse reactions were

• injection site pain,
• hematoma,
• pruritus and
• anesthesia.

Nonserious systemic adverse reactions were

• malaise,
• abdominal pain,
• vomiting,
• dyspnea,
• generalized erythema,
• vertigo,
• asthma crisis and
• urticaria.

Dengvaxia is a suspension for injection (supplied as a lyophilized powder to be reconstituted with the supplied diluent, 0.4% NaCl). A single dose, after reconstitution, is 0.5 mL.

Concomitant Administration with Other Vaccines

Data are not available to establish the safety and immunogenicity of concomitant administration of Dengvaxia with recommended adolescent vaccines.

Immunosuppressive Treatments

Immunosuppressive therapies may reduce the immune response to Dengvaxia, including

• irradiation,
• antimetabolites,
• alkylating agents,
• cytotoxic drugs and
• corticosteroids (used in greater than physiologic doses).

Drug/Laboratory Test Interactions

Dengvaxia may cause temporary depression of tuberculin purified protein derivative (PPD) test sensitivity, leading to false negative results. Tuberculin testing should be performed before Dengvaxia is administered or at least 1 month following vaccination with Dengvaxia.

No specific studies of Dengvaxia have been performed among pregnant women. A limited number of cases of inadvertent exposure during pregnancy were reported during clinical studies. Isolated adverse pregnancy outcomes (e.g., stillbirth, intrauterine death, spontaneous abortion, blighted ovum) have been observed for these exposed pregnancies, with similar frequency and nature in the vaccinated individuals compared to the control group, and with risk factors identified for all cases. Available data in pregnant women are not sufficient to determine the effects of Dengvaxia on pregnancy, embryo-fetal development, parturition and post-natal development.

Human data are not available to assess the impact of Dengvaxia on milk production, its presence in breast milk, or its effects on the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dengvaxia and any potential adverse effects on the breastfed child from Dengvaxia or from the underlying maternal condition. For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine. A lactation study in which female mice were administered a single dose of Dengvaxia on day 14 of lactation did not show the presence of Dengvaxia in breast milk.