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 to 60 years under the New Drugs and Clinical Trials (NDCT) Rules, 2019.
QDENGA is the first dengue vaccine approved in India and can be administered to individuals regardless of their previous exposure to dengue, without the need for pre-vaccination testing.
The approval marks a significant milestone in strengthening dengue prevention efforts in India, where the disease continues to pose a major public health challenge.
Dengue is a mosquito-borne viral disease that represents a serious global public health threat, with transmission reported in more than 125 countries worldwide.
India accounts for nearly one-third of the global dengue burden. Although more than 113,000 dengue cases were officially reported in 2025, modelling analyses suggest the actual burden is significantly higher, likely amounting to tens of millions of infections annually.
QDENGA is a tetravalent, live-attenuated vaccine designed to provide protection against all four dengue virus serotypes. It is administered as a 0.5 mL subcutaneous injection in a two-dose regimen, with the second dose given three months after the first.
The vaccine is recommended by the World Health Organization (WHO) for use in dengue-endemic areas and supports its introduction into public immunisation programmes in regions with high transmission, without requiring pre-vaccination screening. QDENGA has also received WHO prequalification, confirming that it meets international standards for quality, safety, and efficacy, making it eligible for procurement through global agencies such as UNICEF and the Pan American Health Organization (PAHO) to support broader access.
QDENGA has now been approved in 43 countries across Asia, Latin America, and Europe, including India, with more than 32 million doses distributed globally through both public and private immunisation programmes. The vaccine is included in Brazil’s National Immunisation Programme and is also available through public vaccination programmes in Argentina, Colombia, and Indonesia.
Dr. Mahender Nayak, Head of Intercontinental Markets, said the latest seven-year data for QDENGA demonstrate continued protection against dengue infection and dengue-related hospitalisation across all four virus serotypes.
“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,” he said.
Millions of people in India remain at risk of dengue each year due to widespread endemic transmission, rapid urbanisation, and climate-related factors that contribute to mosquito breeding. These factors have made dengue a year-round public health concern, with seasonal outbreaks continuing to place significant pressure on healthcare systems.
Managing dengue remains challenging as there is no specific treatment for the disease. In severe cases, it can rapidly progress to life-threatening complications requiring hospitalisation and intensive care.
Peter Streibl, General Manager of the Southeast Asia and India Cluster, said dengue is a shared regional challenge that requires cooperation across borders and sectors.
“Dengue is a shared regional challenge that requires collaboration across borders and sectors. Takeda is committed to working with governments, public health authorities, healthcare professionals, and partners across South and Southeast Asia not only to support access to QDENGA, where approved and recommended, but also to strengthen broader dengue prevention efforts, including surveillance, awareness, vector control, and community engagement,” he said.
Dr. Goh Choo Beng, Medical Affairs Head for the Southeast Asia and India Cluster, said India carries a substantial dengue burden, with all four dengue virus serotypes documented as circulating simultaneously in several regions. He noted that QDENGA is designed to provide protection against all four serotypes, regardless of previous dengue exposure.
Approval Based on Extensive Clinical Trials
The approval of QDENGA in India is based on findings from Takeda’s global clinical development programme, which included 19 Phase I, II, and III clinical trials involving more than 28,000 participants across dengue-endemic and non-endemic regions.
This included the pivotal Phase III TIDES (DEN-301) trial, which evaluated the vaccine in more than 20,000 participants across eight countries over an extended follow-up period to assess its long-term safety and efficacy.
Twelve months after the second dose, the trial achieved its primary endpoint by demonstrating an overall vaccine efficacy of 80.2% against virologically confirmed dengue (VCD).
At 18 months, the study also met a key secondary endpoint by demonstrating 90.4% efficacy against dengue-related hospitalisation.
After 4.5 years, two doses of QDENGA continued to provide 84.1% efficacy in preventing dengue-related hospitalisations. The vaccine has also demonstrated sustained safety and efficacy for up to seven years across all four dengue virus serotypes.
The approval is further supported by data from the Phase III DEN-302 clinical trial conducted among Indian participants aged 4 to 60 years, which evaluated the vaccine’s safety and immunogenicity. The study found that QDENGA was well tolerated, safe, and immunogenic in healthy adults, adolescents, and children.
These clinical findings are reinforced by ongoing real-world evidence generation and pharmacovigilance efforts aimed at further strengthening understanding of the vaccine’s safety profile and long-term impact.
Following approval by the DCGI, Takeda said it will continue working with Indian regulatory authorities, public health stakeholders, and healthcare providers to support the planning, rollout, and availability of QDENGA across India.
(Source: India Today)
