India’s first dengue vaccine approved: DCGI clears Takeda’s Qdenga for those aged 4 to 60

The two-dose vaccine protects against all four dengue virus strains without requiring pre-vaccination testing, as India battles a rising dengue burden.

4 min readPuneUpdated: Jul 21, 2026 04:51 AM IST

India’s first dengue vaccine approved: DCGI clears Takeda’s Qdenga for those aged 4 to 60

The approval comes at a critical time for public health, with reported dengue cases in India increasing 11-fold over the past two decades. (Image generated using AI)

The Drug Controller General of India (DCGI) has approved Japanese company Takeda Biopharmaceuticals India’s dengue vaccine, Qdenga, making it the first such vaccine to be greenlighted in India. It is designed to protect against all four dengue virus strains (DENV-1, DENV-2, DENV-3 and DENV-4) and can be administered regardless of prior dengue exposure. It does not require pre-vaccination testing, the company said.

The vaccine is administered subcutaneously. It comes as a two-dose regimen of 0.5 mL each, with doses given three months apart. The price has not been announced yet but since Takeda has entered into a manufacturing partnership with Hyderabad-based Biological E to produce up to 50 million doses annually, costs are expected to be competitive for the Indian market. Pricing will also depend on whether this gets incorporated into government immunisation programmes later.

Also Read | Dengue is spreading fast: Can cutting-edge science outsmart it at last?

The approval comes at a critical time for public health, with reported dengue cases in India increasing 11-fold over the past two decades.

India continues to account for nearly one-third of the global dengue burden. 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 an official statement issued today, Dr Mahender Nayak, head of Intercontinental Markets, Takeda, said, “Dengue is a growing public health challenge and India needs sustained, evidence-based prevention.” 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.

Dr Goh Choo Beng, Medical Affairs Head, Southeast Asia and India Cluster, said, “India carries a substantial dengue burden, and all four dengue virus serotypes have been documented as co-circulating in several regions. The approval represents an important step in strengthening India’s comprehensive approach to dengue prevention, alongside vector control, surveillance, community awareness and other public health measures.”

Also Read | Serum Institute of India ties up with DNDi for Phase III trial of dengue therapy

What is the vaccine about?

It is designed to protect against all four dengue virus serotypes. It is approved for use in the four to 60 year age group, regardless of previous dengue exposure, without the need for pre-vaccination testing.It is the most extensively studied dengue vaccine, with long-term clinical data demonstrating sustained protection against dengue disease and dengue-related hospitalisation.

Story continues below this ad

What did clinical trials show?

The approval in India is based on results from Takeda’s global clinical development programme, 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 evaluate 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 the 4–60 age group. The study demonstrated that QDENGA was found to be tolerated, safe and immunogenic in healthy adults, adolescents and children. These clinical outcomes are further supported by real-world evidence generation and ongoing pharmacovigilance to deepen understanding of the vaccine’s safety and impact.

WHO nod

The vaccine has also received WHO prequalification, 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.

Story continues below this ad

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.

Anuradha Mascarenhas

Anuradha Mascarenhas is a Senior Editor at The Indian Express, based in Pune. With a career spanning three decades, she is one of the most respected voices in Indian journalism regarding healthcare, science and environment and research developments. She also takes a keen interest in covering women's issues . Professional Background Education: A gold medalist in Communication and Journalism from Savitribai Phule Pune University and a Master’s degree in Literature. Author: She authored the biography At The Wheel Of Research, which chronicles the life and work of Dr. Soumya Swaminathan, the former Chief Scientist at the WHO. Key Focus: She combines scientific accuracy with storytelling, translating complex medical research into compelling public and human-interest narratives. Awards and Recognition Anuradha has won several awards including the Press Council of India's national award for excellence in journalism under the gender based reporting category in 2019 and the Laadli Media award (gender sensitivity -2024). A recipient of the Lokmat journalism award (gender category-2022), she was also shortlisted for the RedInk awards for excellence in journalism-2021. Her debut book At The Wheel Of Research, an exclusive biography of Dr Soumya Swaminathan the inaugural chief scientist of World Health Organisation was also nominated in the Popular Choice Category of JK Paper AUTHER awards. She has also secured competitive fellowships including the Laadli Media Fellowship (2022), the Survivors Against TB – New Research in TB Media Fellowship (2023) and is part of the prestigious 2025 India Cohort of the WomenLift Health Leadership Journey.” Recent Notable Articles (Late 2025) 1. Cancer & Specialized Medical Care "Tata Memorial finds way to kill drug-resistant cancer cells" (Nov 26, 2025): Reporting on a breakthrough for triple-negative breast cancer, one of the most aggressive forms of the disease. Discipline, diet and purpose; How a 97-year-old professor defies ageing'' (Nov 15, 2025) Report about Prof Gururaj Mutalik, the first Head of Department at Pune's B J Government Medical College who at 97 credits his longevity to healthy habits and a strong sense of purpose. 2. Environmental Health (The "Breathless Pune" Series) Long-term exposure even to 'moderate' air leads to chronic heart, lung, kidney issues" (Nov 26, 2025): Part of an investigative series highlighting that even "safe" pollution levels are damaging to vital organs. "For every 10 µg/m3 increase in PM2.5 level, there was 6-8% jump in medicine sales" (Nov 23, 2025): Using commercial data to prove the direct link between air quality and respiratory illnesses in Pune. 3. Lifestyle & Wellness News "They didn't let cancer, diabetes and heart disease stop them from travelling" (Dec 22, 2025): A collaborative piece featuring survivors who share practical tips for traveling with chronic conditions. At 17, his BP shot up to 200/120 mmHG; Lancet study flags why child and teen hypertension doubled between 2000 and 2020'' (Nov 12,2025)--A report that focusses on 17-year-old-boy's hypertensive crisis and reflects the rising global trend of high blood pressure among children and adolescents. 4. Scientific Recognition & Infrastructure For promoting sci-comm, gender diversity: IUCAA woman prof highlighted in Nature" (Nov 25, 2025): Covering the global recognition of Indian women scientists in gender studies and physics. Pune researchers find a spiral galaxy like the Milky Way from early universe'' (December 3, 2025)- A report on how Indian researchers discovered a massive galaxy that existed when the universe was just 1.5 billion years old , one of the earliest to have been observed so far. Signature Beat: Health, Science & Women in Leadership Anuradha is known for her COVID-19 reportage, where she was one of the first journalists to provide detailed insights into the Covishield and Covaxin trials. She has a dedicated interest in gender diversity in health and science, often profiling women researchers who are breaking the "leaky pipeline" in STEM fields. Her writing style is scrupulous, often featuring interviews with top-tier scientists and health experts from various institutions. ... Read More

Loading Recommendations...

Jul 31: Latest News

Live Blog