The Drug Controller General of India (DCGI) has granted market authorisation for QDENGA, the first approved dengue vaccine in India, as announced by Takeda Biopharmaceuticals India Pvt Ltd on July 20. This vaccine is designed for individuals aged four to sixty and can be administered without pre-vaccination testing, irrespective of prior exposure to dengue. The approval aligns with the New Drugs and Clinical Trials (NDCT) Rules of 2019.

This development is deemed a significant step towards enhancing efforts to prevent dengue in India, where the disease poses a major public health concern. The vaccine addresses a growing need as the prevalence of dengue continues to challenge healthcare systems across the nation.

Dengue’s Public Health Impact in India

Dengue, a viral disease transmitted by mosquitoes, is a prominent public health issue worldwide, affecting over 125 countries. India bears a substantial burden, accounting for nearly one-third of the global dengue cases. In 2025, reported incidences surpassed 113,000, although projections suggest actual infections may reach into the tens of millions annually.

The rise in dengue cases can be attributed to several factors, including rapid urbanisation and climate conditions that facilitate mosquito breeding. As a result, dengue has transitioned into a year-round public health threat, with spikes occurring throughout the year, thereby straining healthcare resources.

The seriousness of dengue is further compounded by its management challenges, characterised by a lack of specific treatments and the potential for rapid progression to severe forms requiring hospitalisation. This has necessitated a robust response from healthcare authorities.

Clinical Trials and Efficacy of QDENGA

The approval of QDENGA in India is backed by a comprehensive global clinical development programme involving 19 clinical trials, with over 28,000 participants across both endemic and non-endemic regions. One key trial, the Phase III TIDES (DEN-301) study, evaluated over 20,000 participants from eight countries to assess the long-term safety and efficacy of the vaccine.

Results from these studies indicate that at 12 months post the second dose, QDENGA achieved an overall efficacy of 80.2% against virologically confirmed dengue. Furthermore, the vaccine displayed 90.4% efficacy against dengue-related hospitalisations at 18 months, demonstrating its effectiveness in a critical secondary endpoint.

Following a period of 4.5 years, the vaccine maintained an efficacy rate of 84.1% in preventing hospitalisation due to dengue. The data highlights the vaccine’s sustained safety and efficacy across all four dengue virus serotypes, with additional evidence gathered from a Phase III clinical trial assessing its immunogenicity in Indian participants aged four to sixty.

Future Collaboration and Public Health Measures

On the importance of collaborative efforts, Takeda officials expressed their commitment to work alongside governmental bodies and health authorities in India. They aim to bolster dengue prevention strategies including surveillance, community engagement, and vector control measures.

Dr Goh Choo Beng, head of medical affairs for Southeast Asia and the India cluster, reiterated the necessity for a comprehensive approach to tackle dengue, emphasising the vaccine’s ability to protect against all four serotypes.

QDENGA is distinguished as a tetravalent, live-attenuated vaccine, administered in two doses spaced by three months. It has received prequalification from the World Health Organisation, which assures its adherence to global quality standards, and allows for distribution through international health procurement channels. Following this regulatory approval, Takeda plans to facilitate QDENGA’s availability in India through ongoing collaboration with health stakeholders.

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