Vaccine Academy › Vaccine School › Travel
Content current as of October 12, 2026. AI-assisted draft; not yet reviewed by a licensed pharmacist. Current CDC schedules: immunization schedules.
- The disease and why it matters
- Video and figures
- Get CE credit
- Products available
- Who should get it
- Dosing and schedule, including catch-up
- Administration
- Storage and handling
- Contraindications and precautions
- Safety and adverse events
- Special populations
- Counseling pearls for the pharmacy counter
- Common patient questions
- References
The disease and why it matters
Dengue is endemic throughout the tropics and subtropics, occurs in more than 100 countries and destinations (including Puerto Rico, the U.S. Virgin Islands and U.S.-affiliated Pacific Islands), and burden continues to grow in sub-Saharan Africa, Latin America and Asia, with estimates of 390 million infections and 96 million symptomatic cases per year. [1]
Dengue is caused by one of four viruses spread through the bite of an infected mosquito; infection with one virus does not protect against the other three; most infected people have no symptoms or mild disease, a smaller number develop severe dengue (a medical emergency), and severe dengue can lead to death. [2]
During 2010 to 2021 a total of 7,528 travel-related dengue cases were reported in the United States, 3,135 patients required hospitalization and 19 died; travel-associated cases increased in 2019 and 2022 to 2024 with more than 1,400 cases each year. [1]
Video and figures
Video
Get CE credit
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Products available
Dengvaxia is a live tetravalent dengue vaccine (Sanofi Pasteur) for subcutaneous injection; CDC says that Qdenga is not available or recommended for use in the United States because, as of 2023, the manufacturer voluntarily withdrew its application to FDA, and that TV003, a single-dose dengue vaccine developed by the National Institutes of Health, has additional phase 3 results pending. [3] [1]
| Item | Statement |
|---|---|
| Manufacturer (FDA page) | Sanofi Pasteur, Inc. [4] |
| Indication | Prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4; approved for use in individuals 6 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas [3] |
| Presentation | Suspension for injection (0.5 mL) supplied as a lyophilized powder to be reconstituted with the supplied diluent (0.4% NaCl) [3] |
In 2024 the manufacturer announced that Dengvaxia will be discontinued because of a lack of demand in the global market; the FDA DENGVAXIA page is marked content current as of 08/08/2023 and the label posted on that page shows a placeholder revision date ("XX/2023"). [1] [4] [3]
Who should get it
CDC (Yellow Book 2026, dengue chapter)
As of April 23, 2025
There are currently no dengue vaccines recommended for travelers in the United States; Dengvaxia is recommended for children aged 9 through 16 years with laboratory-confirmed previous dengue virus infection who are living in areas of the United States where dengue is endemic (American Samoa, Puerto Rico, the U.S. Virgin Islands, and freely associated states including the Federated States of Micronesia, the Republic of the Marshall Islands and the Republic of Palau). [1]
FDA label (DENGVAXIA)
As of August 8, 2023
The label is approved for individuals 6 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas, a wider age range than CDC's 9 through 16 years; the label says its safety and effectiveness have not been established in individuals living in dengue nonendemic areas who travel to dengue endemic areas. [3] [1]
CDC VIS (January 31, 2025 edition)
As of January 31, 2025
The VIS says dengue vaccine is recommended for children 9 through 16 years old who have a laboratory-confirmed history of dengue infection and live in an area where dengue is common, and that it is NOT recommended for travelers. [2]
Because Dengvaxia can increase the risk for severe illness and hospitalization if a person who has not already been infected gets dengue after vaccination, CDC recommends serologic tests with acceptable performance (at least 75% sensitivity and at least 98% specificity) to test for evidence of previous infection; only people with laboratory-confirmed previous infection who live in endemic areas are eligible, and there is a low risk that some vaccinated people can still get dengue. [1]
The label says there is no FDA-cleared test available to determine a previous dengue infection, and that previous infection can be assessed through a medical record of a previous laboratory-confirmed dengue infection or through serological testing prior to vaccination. [3]
Dosing and schedule, including catch-up
Three 0.5 mL doses are given 6 months apart (month 0, 6 and 12); the VIS says the second dose should be given 6 months after the first and the third dose 6 months after the second. [3] [2]
The VIS says dengue vaccine may be given at the same time as other vaccines. [2]
Administration
- Reconstitute the lyophilized vaccine antigen with 0.6 mL withdrawn from the vial of saline diluent (0.4% NaCl) and swirl gently; withdraw 0.5 mL and administer subcutaneously immediately or store refrigerated at 2 to 8 °C (36 to 46 °F) and use within 30 minutes; do not administer by intramuscular injection. [3]
- Discard reconstituted vaccine if not used within 30 minutes; do not remove the vial stoppers or metal seals holding them in place; changing needles between withdrawing and injecting is not necessary unless the needle has been damaged or contaminated. [3]
Storage and handling
- Store the lyophilized vaccine antigen and saline diluent in a refrigerator at 2 to 8 °C (36 to 46 °F); do not freeze; protect from light; do not use after the expiration date. [3]
Contraindications and precautions
| Source | Statement |
|---|---|
| Dengvaxia label | A history of severe allergic reaction to a previous dose or to any component; immunocompromised individuals. [3] |
| Younger than 6 years | Not approved; regardless of previous infection, an increased risk of severe and hospitalized dengue can occur after vaccination and subsequent infection with any dengue virus serotype. [3] |
| Not previously infected or unknown | Not approved; those not previously infected are at increased risk for severe dengue disease when vaccinated and subsequently infected. [3] |
Safety and adverse events
Most frequently reported adverse reactions regardless of serostatus in ages 9 through 16 years were headache (40%), injection-site pain (32%), malaise (25%), asthenia (25%) and myalgia (29%); in ages 6 through 8 years headache (27%), injection-site pain (28%), malaise (19%), asthenia (13%) and myalgia (15%). [3]
The most common adverse reactions occur within 14 days following administration (headache, injection-site pain, malaise, asthenia and myalgia), and individuals should seek medical care if they develop signs and symptoms of dengue fever, especially severe dengue warning signs (high fever, severe abdominal pain or tenderness, persistent vomiting, mucosal bleeding, somnolence and hyperactivity). [3]
Special populations
Pregnancy and lactation: the label says no specific studies have been performed among pregnant women and that a pregnancy exposure registry exists; human data are not available to assess its presence in breast milk or effects on the breastfed child. [3]
Age: not approved for individuals younger than 6 years because clinical studies strongly suggest it would be unsafe; safety and effectiveness have not been established in adults 65 years of age and older. [3]
Travelers: non-vaccine prevention is the main protection; no specific medication is available to prevent dengue, risk increases with duration of travel and disease incidence at the destination (for example local epidemics or the rainy season), and travelers going to the tropics for any length of time should take steps to prevent mosquito bites. [1]
Counseling pearls for the pharmacy counter
- Dengue vaccine can help protect against dengue in people who have had dengue in the past; it is not recommended for travelers. [2]
- To receive the vaccine a child must have had dengue in the past, confirmed by blood testing, because the vaccine could increase the risk of severe dengue and hospitalization in children who have not had dengue before and are infected after vaccination. [2]
- Three doses are needed, 6 months apart; seek medical care for signs of dengue, especially warning signs of severe dengue. [2] [3]
Common patient questions
Should a traveler going to Thailand receive Dengvaxia?
No. CDC says there are currently no dengue vaccines recommended for travelers in the United States, and the VIS says dengue vaccine is NOT recommended for travelers. [1] [2]
A 12-year-old in Puerto Rico had dengue 2 years ago per a lab record. Eligible?
CDC says Dengvaxia is recommended for children 9 through 16 years with laboratory-confirmed previous dengue infection living in endemic U.S. areas such as Puerto Rico; evidence of previous infection must be a laboratory-confirmed record or acceptable serologic testing. [1] [3]
Can an 8-year-old with confirmed prior dengue be vaccinated?
The label includes ages 6 through 16 years, but CDC's recommendation is for ages 9 through 16 years; the two sources differ. [3] [1]
Can Dengvaxia be given intramuscularly?
No. It is administered subcutaneously and must not be given by intramuscular injection. [3]
Is Dengvaxia still being manufactured?
The Yellow Book says that in 2024 the manufacturer announced that Dengvaxia will be discontinued due to a lack of demand in the global market. [1]
References
- Centers for Disease Control and Prevention. Dengue. In: CDC Yellow Book: Health Information for International Travel, 2026 edition. Page dated April 23, 2025. Accessed October 12, 2026. https://www.cdc.gov/yellow-book/hcp/travel-associated-infections-diseases/dengue.html. Accessed October 12, 2026.
- Centers for Disease Control and Prevention. Dengue vaccine: what you need to know. Vaccine Information Statement, January 31, 2025. Accessed October 12, 2026. https://www.cdc.gov/vaccines/hcp/current-vis/dengue.html. Accessed October 12, 2026.
- DENGVAXIA (dengue tetravalent vaccine, live), suspension for subcutaneous injection: prescribing information as posted on FDA's product page (revision date shown as a placeholder, "XX/2023"). Sanofi Pasteur Inc. U.S. Food and Drug Administration. Accessed October 12, 2026. https://www.fda.gov/media/124379/download?attachment. Accessed October 12, 2026.
- U.S. Food and Drug Administration. DENGVAXIA product page (content current as of 08/08/2023). Accessed October 12, 2026. https://www.fda.gov/vaccines-blood-biologics/dengvaxia. Accessed October 12, 2026.
For professional education. Check current labeling and guidance before acting. Not medical advice.
