Takeda has secured approval from the Drug Controller General of India (DCGI) for Qdenga, making it the first vaccine authorized in the country to help protect against dengue, the mosquito-borne viral disease.
The approval covers all four dengue virus serotypes and allows the vaccine to be administered to children and adults between the ages of four and 60, as reported early on Monday by Reuters and a slew of other publications.
Clinical data from a late-stage trial showed that Qdenga provided protection against confirmed dengue infections of just over 80% one year after participants received their second dose. The vaccine has already been approved in dozens of countries worldwide.
Cases of dengue reported in the country shot up by 11 times in the past 20 years, as per Takeda data.
Takeda achieved the first global go-ahead for Qdenga in Indonesia during 2022 after many years of development. The vaccine is built on a live-attenuated dengue serotype 2 virus, which serves as the genetic backbone for protection against all four dengue virus serotypes.
The company had initially planned to introduce Qdenga to the U.S. travel vaccine market. However, those plans changed somewhere in the middle of 2023 when Takeda withdrew its FDA application after the agency requested additional data that had not been generated during the Phase 3 TIDES study.
Beyond India, Qdenga has also received regulatory approvals in countries including Argentina, Brazil, the United Kingdom, Thailand, and several other markets across Europe and Asia.
To support broader access in dengue-endemic regions, Takeda partnered with Indian drugmaker Biological E in early 2024 to manufacture multi-dose vials of Qdenga, with the companies aiming to expand availability before moving into the 2030s.
Qdenga’s clinical development program included as many as 19 Phase 1, 2, and 3 studies involving more than 28,000 participants from both dengue-endemic and non-endemic regions. The centerpiece of the program was the pivotal Phase 3 TIDES (DEN-301) trial, which enrolled over 20,000 people participating from eight countries.
One year after the second dose, the vaccine demonstrated efficacy of about 80% against virologically confirmed dengue. By 18 months, protection against dengue-related hospitalizations exceeded 90%. Follow-up data collected over four years showed that Qdenga reduced the risk of hospitalization by more than 84%, while its safety profile and protective effect remained consistent for as long as seven years across all four dengue virus serotypes.
Additional support for the approval came from the Phase 3 DEN-302 study, which was conducted in India among participants aged four to 60 years. The trial confirmed the vaccine’s safety, tolerability, and ability to generate an immune response in children, adolescents, and adults. Continued pharmacovigilance efforts and real-world evidence have further reinforced those findings.
The World Health Organization (WHO) has also endorsed Qdenga, confirming that it meets international standards for quality, safety, and efficacy. That recognition makes the vaccine eligible for procurement through global organizations such as PAHO and UNICEF, helping expand access in countries where dengue remains a major public health concern.
Qdenga has achieved a historic milestone by becoming the first dengue vaccine to receive regulatory approval in India. The approval represents a significant advancement in the country’s fight against dengue, a mosquito-borne disease that affects millions of people across tropical and subtropical regions. The launch of Qdenga is expected to strengthen preventive healthcare strategies and reduce the burden of severe dengue infections.
Why Qdenga’s Approval Is Significant
The approval of Qdenga marks a breakthrough in dengue prevention. As the first vaccine authorized for use in India against the disease, Qdenga offers healthcare providers an additional tool to protect individuals living in high-risk areas. The decision also highlights growing confidence in vaccine innovation for infectious diseases.
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