Dengue vaccine

Dengue vaccine is a vaccine used for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 for individuals aged 9-16 years with laboratory-confirmed previous dengue infection and living in endemic areas. 

• Dengue vaccine is available under the following different brand names: Dengvaxia

Common side effects of the Dengue vaccine include:

• Headache,
• Injection site reactions (pain, redness, swelling),
• Feeling unwell (malaise),
• Weakness,
• Fever, and
• Muscle pain

Serious side effects of the Dengue vaccine include:

• Hives, 
• Rash, 
• Shaking, 
• Itching, 
• Nausea, 
• Flushing, 
• Dizziness, 
• Difficulty breathing, 
• Chest pain, 
• Fainting, 
• Throat closing, 
• Face swelling

Rare side effects of the Dengue vaccine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

Injectable, lyophilized vaccine antigen for reconstitution

• 4.5-6 log10 CCID-50 per vial
• CCID-50 = 50% cell culture infectious dose

Dengue Disease Prevention

Pediatric dosage

• Vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 for individuals aged 9-16 years with laboratory-confirmed previous dengue infection and living in endemic areas
• 3-dose series; aged 9-16 years: 0.5 mL Subcutaneous 3 doses administered 6 months apart

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Dengue vaccine has severe interactions with the following drug:
  • Onasemnogene abeparvovec
• Dengue vaccine has serious interactions with the following drugs:
  • Abrocitinib
  • Anifrolumab
  • Atoltivimab/maftivimab/odesivimab
  • Ciltacabtagene autoleucel
  • Cyclosporine
  • Elivaldogene autotemcel
  • Idecabtagene vicleucel
  • Ofatumumab sc
  • Ozanimod
  • Ponesimod
  • Satralizumab
  • Teplizumab
  • Tisagenlecleucel
  • Tralokinumab
  • Tuberculin purified protein derivative
  • Upadacitinib
  • Voclosporin
• Dengue vaccine has moderate interactions with at least 182 other drugs.
• Dengue vaccine has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

•  Hypersensitivity
•  Individuals with severe immunodeficiency or immunosuppression due to disease or therapy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dengue vaccine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dengue vaccine?”

Cautions

• May cause hypersensitivity reactions, including anaphylaxis; appropriate medical treatment and supervision must be available following administration
• Vaccination may not protect all individuals; continue personal protection measures against mosquito bites after vaccination
• Syncope can occur following or before vaccination as a psychogenic response to injection with a needle; prevent injury from falling and manage syncopal reactions

Uninfected individuals

• Evaluate individuals for prior dengue infection to avoid vaccinating individuals who have not been previously infected with the 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
• Administration to individuals not previously infected by the dengue virus is associated with an increased risk of severe dengue disease when the vaccinated individual is subsequently infected with any dengue virus serotype
• There is no FDA-cleared test available to determine previous dengue infection; available non-FDA-cleared tests may yield false-positive results owing to cross-reactivity with other flaviviruses

Drug interaction overview

• Data unavailable to establish the safety and immunogenicity of coadministration with recommended adolescent vaccines
• Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (greater than physiologic doses), may reduce the immune response to the dengue vaccine
• A dengue vaccine may cause temporary depression of tuberculin purified-protein derivative (PPD) test sensitivity, leading to false-negative results; perform tuberculin testing before immunization or at least 1-month following

Pregnancy and Lactation

• Available data on pregnant women are not sufficient to determine the effects of the dengue vaccine on pregnancy, embryo-fetal development, parturition, and postnatal development
• Pregnancy exposure registry: 1-800-VACCINE (1-800-822-2463)
• A limited number of inadvertent exposures during pregnancy were reported during clinical studies; isolated adverse pregnancy outcomes (.g, stillbirth, intrauterine death, spontaneous abortion, blighted ovum) observed for these exposed pregnancies, with similar frequency and nature in the vaccinated individuals compared with the control group, and with risk factors identified for all cases

Clinical considerations

• Pregnant women are at increased risk of complications associated with dengue infection compared with nonpregnant women
• Pregnant women with dengue may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery
• Vertical transmission of dengue virus from mothers with viremia at delivery to their infants reported

Fetal/neonatal adverse effects

• Vaccine viremia can occur 7-14 days after vaccination with a duration of below 7 days
• The potential for transmitting the vaccine virus from mother to infant is unknown

Lactation

• Human data are not available to assess the dengue vaccine impact on milk production, its presence in breast milk, or its effects on the breastfed child
• Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the vaccine and any potential adverse effects on the breastfed child from the dengue vaccine or the underlying maternal condition
• Vertical transmission of the dengue virus, including potentially through breastmilk, has been reported