Effectiveness and safety of the tetravalent TAK-003 dengue vaccine: a systematic review.

In Argentina, the dengue virus has experienced an increase in recent years. This study aims to conduct a systematic review to evaluate the effectiveness and safety of the TAK-003 tetravalent dengue vaccine in this context. A systematic review of randomized controlled trials comparing the effectiveness and safety of the vaccine with placebo in the general population was conducted. The search was carried out in Epistemonikos, and two researchers independently assessed the studies. Risk of bias was evaluated using the Cochrane Rob 2 tool. A meta-analysis of the results was performed, and the certainty of evidence was assessed using the GRADE methodology. We concluded, with high certainty of evidence, that the tetravalent dengue vaccine reduces severe infections (RR 0.17, 95% CI 0.12 to 0.24) and infections by the dengue virus (RR 0.40, 95% CI 0.36 to 0.45) in a population ≤17 years. The vaccine may not increase the risk of serious adverse events, although it is important to note the low certainty of evidence (RR 1.04, 95% CI: 0.69-1.55). The use of the tetravalent dengue vaccine decreases the risk of severe and non-severe dengue infections in this population. However, there is low certainty of evidence regarding the vaccine's safety. The decision to vaccinate should consider the magnitude of benefits relative to the risk of infection.