Dengue Vaccination: Information for Health Care Providers

Dengue vaccine is recommended for adolescents who are:

• 9–16 years old
• Live in areas where dengue occurs frequently or continuously including:
  • American Samoa
  • Puerto Rico
  • U.S. Virgin Islands
  • Federated States of Micronesia
  • Republic of Marshall Islands
  • Republic of Palau
• Have laboratory-confirmed evidence of previous dengue infection including:
  • Positive dengue RT-PCR test result, or
  • Positive dengue NS1 antigen test result, or
  • Positive results on a pre-vaccination screening dengue virus IgG testing process meeting specific performance standards
  • For more information, see Laboratory Testing Requirements for Vaccination with Dengvaxia Dengue Vaccine.

Do not administer dengue vaccines to

• A person who lacks laboratory evidence of previous dengue infection
• A person who has ever had a severe allergic reaction (e.g., anaphylaxis) after a previous dose of this vaccine
• A person who has a severe allergy to any vaccine component (see the Dengvaxia package insert)
• A person with severe immunodeficiency or immunosuppression due to underlying disease or therapy, including persons with symptomatic HIV infection or CD4+ T-lymphocyte count of <200/mm³.
• A person who lacks laboratory evidence of a previous dengue infection

Healthcare providers should weigh the risks of vaccination against the risk for dengue for the following populations:

• Pregnant women
• Breastfeeding women
• Persons with HIV infection
• Persons with moderate or severe acute illness with or without fever

• Store lyophilized vaccine antigen and saline diluent in a refrigerator at 2°C to 8°C (36°F to 46°F).
• Do not freeze.
• Protect from light.
• Do not use after the expiration date shown on the vial labels of the lyophilized vaccine antigen and saline diluent.
• After reconstitution, administer Dengvaxia immediately or store refrigerated at 2°C to 8°C (36°F to 46°F) and use within 30 minutes.
• Discard reconstituted vaccine if not used within 30 minutes.

The package contains a vial of lyophilized vaccine antigen and a vial of saline diluent (0.4% NaCl).

• After removing the "flip-off" caps, cleanse the lyophilized vaccine antigen and diluent vial stoppers with a sterile alcohol swab. Do not remove the vial stoppers or metal seals holding them in place.
• To reconstitute Dengvaxia, use a sterile needle and syringe to withdraw 0.6 mL from the diluent vial and inject it into the vial of lyophilized vaccine antigen. Swirl the vial gently.
• Changing needles between withdrawing the vaccine from the vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated.
• After reconstitution, the suspension is colorless and may develop trace amounts of white to translucent endogenous proteinaceous particles.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy or contains particles other than trace amounts of white to translucent particles.
• Dengvaxia should not be mixed in the same syringe with other parenteral products.

See the Dengvaxia Package Insert for additional information and ingredient list.

Do not use dengue vaccine, lyophilized vaccine antigen, and saline diluent after the expiration date shown on the vial labels.

Prior to administration, visually inspect the vaccine for particulate matter and/or discoloration. Discard the vial if the solution is cloudy or contains particles other than trace amounts of white to translucent particles.

After reconstitution, administer Dengvaxia immediately or store refrigerated at 2°C to 8°C (36°F to 46°F) and use within 30 minutes. Discard reconstituted vaccine if not used within 30 minutes.

Administer Dengvaxia by the subcutaneous route. The preferred site for children and adolescents is into the fatty tissue overlying the triceps muscle (posterior upper arm) using the appropriate needle length for the age and size of the person receiving the vaccine. The correct needle size for subcutaneous injections is ⅝", 23–25 gauge.

• Dosage: 0.5 mL per dose
• Route: Subcutaneous

Administer the Dengvaxia vaccine to children aged 9 through 16 years old who have laboratory confirmation of a previous dengue virus infection. Each child requires 3 doses, each dose given 6 months apart (at 0, 6, and 12 months).

Do not predraw vaccine doses. There are no data on the stability of vaccines stored in syringes filled by healthcare professionals. Do not open vaccine vials until time of administration.

After reconstitution, Dengvaxia should be administered within 30 minutes. If not used within 30 minutes, discard the vaccine.

Trials have evaluated co-administration of Dengvaxia with other vaccines, including yellow fever, diphtheria, tetanus, acellular pertussis (DTaP), inactivated polio, Haemophilus influenzae types b and a, and measles, mumps, and rubella (MMR). No safety issues have been reported.

Vaccine providers should follow best practice guidance from the Advisory Committee on Immunization Practices, which states that injectable, live-attenuated vaccines not administered simultaneously should be separated by at least 4 weeks.