India Approves First Anti-Dengue Vaccine QDENGA by Takeda Biopharmaceuticals
Takeda Biopharmaceuticals has received approval from India's drug regulator for its dengue vaccine, QDENGA, making it the first of its kind in the country. This vaccine is designed to protect individuals aged 4 to 60 against dengue, regardless of prior infection. With dengue remaining a major public health issue in India, the approval of QDENGA is a significant advancement in combating this disease. The vaccine has shown efficacy against all four dengue virus serotypes and has been distributed widely across 43 countries. The clinical trials supporting its approval demonstrate promising results in preventing dengue infections and hospitalizations, highlighting its potential impact on public health.
| Jul 20, 2026, 15:32 IST
Approval of QDENGA Vaccine in India
On Monday, Takeda Biopharmaceuticals announced that India's drug regulatory authority has granted market authorization for its anti-dengue vaccine, QDENGA. This marks the first dengue vaccine to receive approval for use in the country. According to a statement from Takeda Biopharmaceuticals India, the Drug Controller General of India (DCGI) has authorized QDENGA for individuals aged 4 to 60 years to prevent dengue fever, in accordance with the New Drugs and Clinical Trials (NDCT) Rules, 2019. The company highlighted that QDENGA is the first dengue vaccine to be approved in India and can be administered to individuals regardless of whether they have previously contracted dengue, eliminating the need for prior testing.
Dengue's Impact on Public Health
Dengue continues to pose a significant public health challenge in India, with thousands of cases reported annually. As per data from the National Vector Borne Disease Control Program, there were 6,927 reported cases and 10 fatalities by February this year. The disease is prevalent across most regions of the country, contributing to nearly one-third of global dengue cases.
Efficacy and Global Reach of QDENGA
The vaccine is effective against all four serotypes of the dengue virus. Mahendra Nayak, Head of Intercontinental Markets at Takeda, stated that new data from seven years of research indicates that QDENGA consistently provides protection against dengue infections and hospitalizations across all four serotypes, marking a significant achievement for communities and health systems. Since its launch in 2022, QDENGA has received approval in 43 countries and over 32 million doses have been distributed worldwide. Dengue remains a year-round public health concern with no specific treatment available, and its severe form, dengue hemorrhagic fever, can be fatal.
Clinical Trials and Results
The approval is based on results from Takeda's global clinical development program, which involved over 28,000 participants from dengue-affected and non-affected areas across 19 Phase I, II, and III clinical trials. A key Phase III trial, TIDES (DEN-301), assessed the long-term safety and efficacy of the vaccine in more than 20,000 individuals across eight countries. Twelve months after the second dose, the study achieved its primary endpoint, demonstrating an overall efficacy of 80.2% against confirmed dengue. Eighteen months later, it showed a 90.4% efficacy in preventing hospitalizations due to dengue, a crucial secondary endpoint. After 4.5 years, the two doses of QDENGA demonstrated an 84.1% efficacy in preventing hospitalizations due to dengue, maintaining consistent protection against all four serotypes for seven years.