Takeda's Dengue Vaccine TAK-003 Demonstrates 80.2% Efficacy in Pivotal Phase 3 Trial

Compiled by Fan Dongdong

Although Sanofi has already established a leading position in this field, Takeda Pharmaceutical Company Limited has still invested significant time, effort, and financial resources into its dengue vaccine program. Recently, the Japanese pharmaceutical giant achieved a major breakthrough, with its dengue vaccine, TAK-003, demonstrating an efficacy rate of 80.2% in large-scale Phase 3 clinical trials.

In the TIDES study, researchers conducted a placebo-controlled trial of TAK-003 involving 20,000 participants aged 4 to 16 years in dengue-endemic countries across Latin America and Asia. In the trial, the number of participants in the TAK-003 group was twice that in the placebo group.

Researchers tracked 61 dengue cases in the vaccine group and 149 patients in the placebo group. The trial results, published in the New England Journal of Medicine, showed that the vaccine efficacy reached 80.2% among patients who received two doses of TAK-003.

Notably, the efficacy of TAK-003 varies across different dengue serotypes: it demonstrated an efficacy rate of 73.7% against dengue serotype 1, 97.7% against serotype 2, and 62.6% against serotype 3. In this study, researchers did not track a sufficient number of dengue serotype 4 cases; therefore, the specific efficacy of TAK-003 against this serotype remains undetermined for now. Takeda stated that these study results are expected to form the basis for regulatory submissions. Derek Wallace, Project Leader for Takeda’s Dengue Vaccine Program, noted that TAK-003 also showed significant efficacy in preventing dengue infection, with an overall efficacy rate of 74.9%.

As is well known, the world’s first dengue vaccine was Dengvaxia, developed by Sanofi. Launched in 2016, the vaccine faced a major setback in late 2017 when Sanofi announced that new analyses indicated it could potentially lead to infection in certain individuals. Subsequent clinical trials confirmed these findings, revealing serious safety concerns during its use and resulting in dozens of deaths worldwide.

A series of black swan events have derailed Sanofi’s 20-year development of its dengue vaccine, leaving the company facing numerous challenges regarding the safety of Dengvaxia and its rollout in the Philippines. In 2018, the company did not even disclose sales figures for the vaccine.

Nevertheless, Takeda remains confident in the development of its dengue vaccine. This week, Takeda invested €130 million to open a factory in Germany to meet global demand for its dengue products following their market launch.

Reference Source: Takeda's Dengue Vaccine 80% Effective in Large-Scale Phase 3 Trial