India approves first dengue vaccine QDENGA for people aged 4-60 years

The Drug Controller General of India (DCGI) has approved Takeda Biopharmaceuticals India's dengue vaccine, QDENGA, for the prevention of dengue in individuals aged 4–60 years under the New Drugs and Clinical Trials (NDCT) Rules, 2019.

QDENGA is the first dengue vaccine approved in India and can be used in individuals regardless of previous dengue exposure, without the need for pre-vaccination testing.

This approval marks an important step in strengthening dengue prevention efforts in India, where the disease remains a significant public health challenge.

Dengue is a mosquito-borne viral disease that poses a significant global public health threat, with prevalence in over 125 countries.

India accounts for nearly one-third of the global dengue burden. In 2025, reported cases exceeded 113,000, but modelling analyses suggest the dengue burden in India appears to be higher than reported, likely representing tens of millions of infections each year.

QDENGA is a tetravalent, live-attenuated vaccine designed to provide protection against all four dengue virus serotypes. The vaccine is administered subcutaneously as a 0.5 mL two-dose regimen, with doses given three months apart.

QDENGA is recommended by the WHO for use in dengue-endemic settings and supports its introduction into public immunisation programmes in areas with high transmission, without the need for pre-vaccination screening. The vaccine has also received WHO pre-qualification, confirming it meets global standards for quality, safety, and efficacy, and enabling eligibility for procurement through international agencies such as UNICEF and PAHO to support wider access.

QDENGA has been approved in 43 countries across Asia, Latin America, and Europe, including India, with more than 32 million doses distributed globally through public and private programmes. It is included in Brazil’s National Immunisation Programme and is available through public programmes in Argentina, Colombia, and Indonesia.

Dr. Mahender Nayak, Head of Intercontinental Markets, said, "The latest seven-year



data for QDENGA show continued protection against dengue infection and hospitalisation across all four serotypes, an important milestone for communities and health systems. Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India.”

The approval in India is based on results from Takeda’s global clinical development program, involving 19 Phase 1, 2, and 3 clinical trials with over 28,000 participants in both endemic and non-endemic regions. This included the pivotal Phase III TIDES (DEN-301) trial, which evaluated the vaccine in over 20,000 participants across eight countries over an extended period to assess both the long-term safety and efficacy of QDENGA.

At 12 months following the second dose, the study met its primary endpoint, demonstrating an overall vaccine efficacy of 80.2% against virologically confirmed dengue (VCD). At 18 months, the study also demonstrated 90.4% efficacy against dengue-related hospitalisation, meeting a key secondary endpoint of the study.

After 4.5 years, two doses of QDENGA provided 84.1% vaccine efficacy in preventing dengue-related hospitalisations. Notably, the vaccine has also shown sustained safety and efficacy for up to seven years across all four dengue virus serotypes.

This approval is also supported by data from a Phase III clinical trial (DEN-302) conducted in Indian participants, which evaluated the safety and immunogenicity of the vaccine in individuals aged 4–60 years. The study demonstrated that QDENGA was well tolerated, safe, and immunogenic in healthy adults, adolescents, and children.

These clinical outcomes are further supported by real-world evidence generation and ongoing pharma-covigilance to deepen understanding of the vaccine’s safety and impact.

Following approval by the DCGI, Takeda will continue to collaborate with Indian regulatory authorities, public health stakeholders, and healthcare providers to support the planning, delivery, and availability of QDENGA in India.