Takeda Pharmaceutical Company Limited recently announced that the results from the primary endpoint analysis of the ongoing pivotal Phase 3Tetravalent Immunization against Dengue Efficacy Study (TIDES)trial of its dengue vaccine candidate (TAK-003) were published in theNew England Journal of Medicine.

Takeda has said that its dengue vaccine candidate demonstrated protection against virologically-confirmed dengue (VCD), the trial primary endpoint, in children ages four to 16 years.

“The results of this first analysis are very encouraging, indicating that the vaccine could potentially provide important public health benefits against dengue fever and hospitalization,” said Humberto Reynales, Lead author of theNew England Journal of Medicinepaper. “It will be important to further analyze the trial results over time in order to assess the long-term efficacy and safety of the vaccine. If longer follow-up data confirm this initial observation, we are looking at a significant step forward in the global fight against dengue.”

“According to the World Health Organization, dengue represents one of the ten biggest global health threats, and it is critical that we have access to a safe and effective vaccine candidate that can reduce the devastating impact dengue fever has in endemic regions,” said In-Kyu Yoon, M.D., Senior Advisor, International Vaccine Institute. “Historically, vaccine development against dengue has been challenging, especially for people who haven’t previously been exposed to dengue, and these results demonstrate protection from dengue fever, including among many participants without prior dengue.”

“We are excited to share this long-anticipated data from our TIDES trial, which is evaluating the performance of our dengue vaccine candidate in a diverse set of countries across Asia and Latin America, and in a study population that intentionally includes a large proportion of children who had never been exposed to dengue,” said Rajeev Venkayya, President of the Global Vaccine Business Unit at Takeda. “While more data is needed to fully understand the safety and efficacy profile of TAK-003, these findings strongly suggest that it could help address the massive global burden of dengue in all populations. We look forward to sharing more data in the coming weeks, and engaging health authorities and the scientific, public health and medical communities on these findings, priorities for future evidence generation, and ways we can work together to maximize the reach and impact of this vaccine upon licensure.”

While more data is needed to fully understand the safety and efficacy profile of TAK-003, these findings strongly suggest that it could help address the massive global burden of dengue in all populations.