About Dengue Vaccine
Sanofi-Pasteur will stop manufacturing its dengue vaccine for children. The manufacturer is discontinuing the vaccine citing a lack of demand in the global market to continue production of this vaccine. CDC, in collaboration with the Puerto Rico Department of Health, will continue alerting health professionals about the discontinuation of Dengvaxia and the use of this vaccine as recommended by the Advisory Committee on Immunization Practices (ACIP). Dengvaxia is safe and effective when administered as recommended. There are two other dengue vaccines either approved or in late stages of development. However, they are not currently available in the United States. People can continue to protect themselves and their families from dengue by preventing mosquito bites and controlling mosquitoes in and around their homes.
Currently, one dengue vaccine is licensed and available in dengue-endemic areas of the United States. Learn about the composition, type, and effectiveness of this vaccine, as well as view the package insert, below.
Type and Composition of Dengvaxia Vaccine
The Dengvaxia vaccine is a tetravalent, live-attenuated dengue vaccine. It was constructed using recombinant DNA technology and replaces several genetic sequences in a yellow fever vaccine virus genome with the homologous sequences from the four dengue virus serotypes, DENV-1–4.
Sanofi Pasteur supplies Dengvaxia as a vial of lyophilized vaccine antigen, which must be reconstituted at the time of use with 0.6 milliliter (mL) from the accompanying vial of diluent (0.4% sodium chloride). After reconstitution, Dengvaxia is a clear, colorless suspension (trace amounts of white to translucent proteinaceous particles may be present).
After reconstitution, each 0.5-mL dose of Dengvaxia contains 4.5 – 6.0 log10 CCID50 of each of the chimeric yellow fever dengue (CYD) virus serotypes 1, 2, 3, and 4. Each 0.5 mL dose is formulated to contain 2 mg sodium chloride and the following ingredients as stabilizers: 0.56 mg essential amino acids (including L-phenylalanine), 0.2 mg non-essential amino acids, 2.5 mg L-arginine hydrochloride, 18.75 mg sucrose, 13.75 mg D-trehalose dihydrate, 9.38 mg D-sorbitol, 0.18 mg trometamol, and 0.63 mg urea.
Each of the four CYD viruses (CYD-1, CYD-2, CYD-3, and CYD-4) in Dengvaxia was constructed using recombinant DNA technology by replacing the sequences encoding the pre-membrane (prM) and envelop (E) proteins in the yellow fever (YF) 17D204 vaccine virus genome with those encoding for the homologous sequences of dengue virus serotypes 1, 2, 3, and 4, respectively. Each CYD virus is cultured separately in Vero cells (African Green Monkey kidney) under serum-free conditions, harvested from the supernatant of the Vero cells and purified by membrane chromatography and ultrafiltration. The purified and concentrated harvest of each CYD virus is then diluted in a stabilizer solution to produce the four monovalent drug substances. The final bulk product is a mixture of the four monovalent drug substances diluted in the stabilizer solution. The final bulk product is sterilized by filtration at 0.22µm, filled into vials and freeze-dried.
Dengvaxia does not contain preservative.
The vial stoppers for the Lyophilized Vaccine Antigen and the Diluent vials of Dengvaxia are not made with natural rubber latex.
Vaccine Efficacy
Among children 9–16 years old with previous dengue virus infection, Dengvaxia has an efficacy of about 80% against the outcomes of symptomatic virologically confirmed dengue, hospitalization for dengue, and severe dengue.
| Outcome | Vaccine Efficacy (95% confidence intervals) |
|---|---|
| Virologically confirmed disease1 | 82% (67%–90%) |
| Hospitalization2 | 79% (69%–86%) |
| Severe disease2 | 84% (63%–93%) |
Recent studies have shown that Dengvaxia provides protection against hospitalization and severe disease for at least 6 years after the last dose of the series. Studies are ongoing to determine how long protection may last.
Dengvaxia should only be administered to children and adolescents 9–16 years old with laboratory-confirmed previous dengue virus infection and living in an area where dengue is endemic (occurs frequently or continuously). For more information, visit Laboratory Testing Requirements for Vaccination with Dengvaxia Dengue Vaccine.
Package Insert
Consult the Dengvaxia package insert for proper storage and handling details, shelf life, and reconstitution instructions.