The Drug Controller General of India (DCGI) has granted marketing authorisation to Qdenga, making it the first dengue vaccine ever approved in the country. Developed by Japanese pharmaceutical company Takeda, the vaccine is indicated for individuals aged 4 to 60 years and can be administered without prior dengue screening. India now joins 43 other countries where Qdenga has already received regulatory approval since its global launch in 2022.
What Is Qdenga?
Qdenga (also known as TAK-003) is a live-attenuated tetravalent dengue vaccine designed to protect against all four serotypes of the dengue virus: DENV-1, DENV-2, DENV-3, and DENV-4. It is manufactured by Takeda GmbH, Germany, and imported into India by Takeda Biopharmaceuticals India Pvt Ltd.
The vaccine is produced using Vero cells, a cell line commonly used for viral vaccine manufacturing. It uses a unique recombinant DNA technology where the DENV-2 virus serves as the genetic backbone, with surface protein genes from the other three serotypes engineered into it. This approach allows the vaccine to trigger a broad immune response against all four virus types.
Qdenga is administered as a two-dose regimen of 0.5 mL each, given by subcutaneous injection (under the skin) three months apart. Since its first approval in Indonesia in 2022, the vaccine has been authorised in over 40 countries across Asia, Latin America, and Europe, and more than 32 million doses have been distributed globally through public and private immunisation programmes.
The World Health Organization (WHO) has given Qdenga prequalification, confirming that it meets global standards for quality, safety, and effectiveness. This makes it eligible for procurement by international agencies such as UNICEF and the Pan American Health Organization (PAHO). The WHO also recommends the vaccine for use in children aged 6 to 16 years in settings with high dengue transmission intensity.
How the Vaccine Works
Qdenga contains live, attenuated (weakened) versions of all four dengue virus serotypes. These weakened viruses cannot cause the disease but are capable of replicating locally at the injection site, teaching the immune system to recognise and fight the actual virus.
When the vaccine is injected, the immune system identifies the attenuated viruses as foreign and produces neutralising antibodies against them. It also triggers cell-mediated immune responses, including T-cells and natural killer cells, creating a multi-layered defence. If the vaccinated person is later bitten by an Aedes mosquito carrying any of the four dengue serotypes, the immune system can quickly recognise the virus and mount a protective response before the infection takes hold.
The clinical efficacy of Qdenga was established through an extensive global programme involving 19 Phase I, II, and III clinical trials with more than 28,000 participants across dengue-endemic and non-endemic regions. The pivotal Phase III TIDES trial (DEN-301) enrolled over 20,000 children aged 4 to 16 years across eight countries in Latin America and Asia.
Key efficacy results from the clinical programme include:
| Endpoint | Efficacy |
|---|---|
| Prevention of symptomatic dengue (12 months after second dose) | 80.2% |
| Prevention of hospitalisation due to dengue (18 months) | 90.4% |
| Prevention of hospitalisation (cumulative, 4.5 years) | 84.1% |
| Protection against DENV-2 (seropositive individuals, 4.5 years) | 80.4% |
| Protection against hospitalisation (seropositive, 4.5 years) | 85.9% |
Long-term data collected over seven years confirms that the two-dose regimen provides sustained protection against dengue infection and hospitalisation across all four serotypes, with no significant safety concerns identified.
A Critical Advantage Over Earlier Vaccines
The biggest difference between Qdenga and the earlier dengue vaccine Dengvaxia (developed by Sanofi) lies in how it handles individuals who have never been infected with dengue before. Dengvaxia, which is based on a yellow fever virus backbone, was found to increase the risk of severe dengue in seronegative individuals (those with no prior dengue infection). As a result, its use requires mandatory pre-vaccination screening to confirm past infection.
Qdenga does not have this limitation. It can be administered regardless of prior dengue exposure and does not require pre-vaccination testing. This simplifies mass vaccination campaigns significantly, especially in a country like India where all four serotypes circulate simultaneously and laboratory screening at scale is not practical.
However, the WHO has noted some nuances. In seronegative individuals, Qdenga shows high efficacy against DENV-1 and DENV-2 but limited efficacy against DENV-3 and DENV-4. For this reason, the WHO currently recommends the vaccine for routine programme use only in children aged 6 to 16 years in high transmission settings, where most children would already have been exposed to the virus by that age. The WHO does not recommend programme use in children under 6 years or in low to moderate transmission settings until more data becomes available.
Despite these caveats, Qdenga remains the most rigorously studied dengue vaccine to date, with the longest follow-up data among all available dengue vaccines.
The Dengue Burden in India
India carries one of the world’s highest dengue burdens, accounting for nearly one-third of the global dengue cases. The disease, transmitted by the Aedes aegypti mosquito, has become a year-round public health emergency rather than a seasonal monsoon illness. Rapid urbanisation, climate change, and widespread mosquito breeding have driven a steady increase in cases over the past two decades.
National surveillance data from the National Center for Vector Borne Diseases Control (NCVBDC) shows the scale of the problem:
| Year | Reported Cases | Reported Deaths |
|---|---|---|
| 2021 | 1,93,245 | 346 |
| 2022 | 2,33,251 | 303 |
| 2023 | 2,89,235 | 485 |
| 2024 | 2,33,519 | 297 |
| 2025 | 1,21,824 | 131 |
The 2023 figure of 2,89,235 cases and 485 deaths represents the highest annual burden in recent history. The actual numbers are believed to be significantly higher because many cases go unreported, particularly in the private healthcare sector. All four dengue virus serotypes co-circulate in several parts of the country, making prevention especially challenging.
The economic cost is also substantial. Studies estimate that India spent over $5.7 billion on dengue-related expenses in 2016, and costs have only risen since then. With the climate crisis extending mosquito breeding seasons, the geographic spread of dengue has expanded beyond traditional urban centres to smaller towns and rural areas.
What This Approval Means
The approval of Qdenga adds a critical new tool to India’s dengue prevention arsenal, which has so far relied entirely on vector control measures such as fogging, larvicide application, and community awareness campaigns. While these measures remain essential, they have not been sufficient to curb the rising trend of infections.
The approval was granted under the New Drugs and Clinical Trials Rules, 2019, following a recommendation by the Subject Expert Committee (SEC) on Vaccines under CDSCO. The decision was supported by a Phase III clinical trial (DEN-302) conducted specifically among Indian participants aged 4 to 60 years, which confirmed the vaccine’s safety and immunogenicity in the Indian population.
Takeda has partnered with Hyderabad-based Biological E to produce up to 50 million doses annually for local and global supply. This partnership is expected to make the vaccine more affordable and accessible in India, though pricing details have not been announced yet. The vaccine will initially be imported from Germany, and availability in the Indian market is expected by the first half of 2027.
The Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority of India, functioning under the Directorate General of Health Services, Ministry of Health and Family Welfare. It is headquartered at FDA Bhawan, Kotla Road, New Delhi. The Drugs Controller General of India (DCGI), currently Dr. Rajeev Singh Raghuvanshi (appointed February 2023), heads the organisation. CDSCO operates under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.
Key Takeaways
- Qdenga (TAK-003) is the first dengue vaccine to be approved in India, granted marketing authorisation by the DCGI under the New Drugs and Clinical Trials Rules, 2019.
- The vaccine is a live-attenuated tetravalent vaccine that protects against all four dengue virus serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
- It is approved for individuals aged 4 to 60 years and does not require pre-vaccination screening for prior dengue exposure.
- The vaccine is administered as a two-dose regimen of 0.5 mL each, given subcutaneously three months apart.
- The Phase III TIDES trial demonstrated 80.2% efficacy against symptomatic dengue at 12 months and 90.4% efficacy against hospitalisation at 18 months, with protection sustained for seven years.
- CDSCO, headquartered in New Delhi, is the National Regulatory Authority of India functioning under the Ministry of Health and Family Welfare.
