Vaccine Safety & Efficacy Data
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, and 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 intervals) |
|---|---|
| Virologically confirmed disease1 | 82% (67%–90%) |
| Hospitalization2 | 79% (69%–86%) |
| Severe disease2 | 84% (63%–93%) |
Duration of vaccine protection
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.
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 recommendation for vaccination 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 as well as the risk of dengue virus infection to the breastfeeding person and infant.
References
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.
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.