Takeda's QDENGA Confirms Long-Term Dengue Protection

Takeda has completed its seven-year Phase 3 TIDES trial of QDENGA confirming that the vaccine provides lasting and reliable protection against dengue.

The study, which also looked at the effects of a booster dose, showed that QDENGA maintains a strong benefit-risk profile, supporting its approved two-dose regimen. This simpler schedule could improve vaccination rates worldwide.

The results come as the world faces a sharp rise in dengue, with more than 14 million cases reported across over 100 countries in 2024. Climate change and rapid urbanization have fueled the outbreak, with Brazil among the hardest-hit nations.

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The inclusion of QDENGA in Brazil’s public vaccination program has already reduced symptomatic cases and dengue-related hospitalizations. After 4.5 years, two doses of QDENGA achieved 61.2% vaccine efficacy (VE) against virologically confirmed dengue and 84.1% VE in preventing hospitalizations. A booster dose increased protection to 74.3% and 90.6% respectively, with consistent results across all four dengue virus serotypes. No new safety issues were observed after the booster.

“QDENGA is the most comprehensively studied dengue vaccine, with more than 60,000 participants globally in the clinical program, and these long-term data highlight the durability of its safety and efficacy profile, across diverse populations worldwide," said Derek Wallace, M.D., president of the Global Vaccine Business Unit at Takeda.

Takeda continues to monitor QDENGA through real-world studies in Brazil and Southeast Asia. Since its first approval in 2022, the vaccine has been authorized in 41 countries, with 18.6 million doses distributed. The World Health Organization’s prequalification of QDENGA underscores its quality and importance in addressing the growing global dengue threat.