Vaccine Safety & Efficacy Data

Key points

  • Dengvaxia is a dengue vaccine recommended for children 9 through 16 years old.
  • Dengvaxia is safe when used in individuals with laboratory evidence of past dengue virus infection living in areas where dengue is common.
  • It has an efficacy rate of about 80% against disease, hospitalization, and severe disease.
Healthcare provider applying a bandage to a pediatric patient's arm as a parent looks on.

Dengvaxia safety

When used in individuals with laboratory evidence of past dengue virus infection, the Dengvaxia dengue vaccine is very safe. The most frequently reported side effects are:

  • Headache
  • Injection site pain
  • Malaise
  • Asthenia
  • Myalgias

Precautions

Fainting (syncope) can occur after any medical procedure, including vaccination. Recent data suggest that syncope after any vaccination is more common in adolescents.

Children and adolescents should be seated or lying down during vaccination. Providers are encouraged to observe patients in seated or lying positions for 15 minutes after vaccination. This is to prevent any injuries that could occur from a fall during a syncopal event.

Dengvaxia 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 interval)
Virologically confirmed disease1
  • 82% (67%–90%)
Hospitalization2
  • 79% (69%–86%)
Severe disease2
  • 84% (63%–93%)

Duration of vaccine protection

Studies show that Dengvaxia protects against hospitalization and severe disease for at least 6 years after the last dose. Studies are ongoing to determine how long protection may last.

Special populations

Pregnancy

Pregnant people were not specifically enrolled and studied in the vaccine trials. Although no significant differences in adverse pregnancy outcomes between vaccinated and unvaccinated people were found, the number of pregnant people enrolled was too small to determine the effect of Dengvaxia on pregnancy.

Vaccine providers should consider the risk of dengue virus infection when making a vaccination recommendation for pregnant people. Pregnant people are at increased risk of dengue-related complications.

Lactation

No data are available to evaluate Dengvaxia and breastfeeding.

Vaccine providers should consider the developmental and health benefits of breastfeeding. They should also consider the risk of dengue virus infection to the breastfeeding person and infant.

Contraindications and precautions

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 people
  • Breastfeeding people
  • Persons with HIV infection
  • Persons with moderate or severe acute illness with or without fever
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Content Source:
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
  1. Hadinegoro SR, Arrendondo-García JL, Capeding MR, et al. Efficacy and long-term safety of a dengue vaccine in regions of endemic disease. N Engl J Med 2015;373:1195-1206.
  2. Sridhar S, Luedtke A, Langevin E, et al. Effect of dengue serostatus on dengue vaccine safety and efficacy. N Engl J Med 2018;379:327-340.