India has approved Qdenga, its first vaccine for preventing dengue.
The two-dose vaccine is approved for people aged four to 60 years.
It protects against all four dengue serotypes without prior infection screening.
India has approved its first vaccine for the prevention of dengue, adding a new tool to the country’s efforts to tackle the mosquito-borne viral disease.
The Drug Controller General of India (DCGI) , has granted marketing authorisation to Qdenga, a tetravalent dengue vaccine developed by Japanese pharmaceutical company Takeda. The vaccine is manufactured by Takeda GmbH in Germany and will be imported by Takeda Biopharmaceuticals India.
The approval covers people aged between four and 60 years and follows an assessment of the vaccine’s quality, safety and effectiveness under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
What Is Qdenga And How Does It Work?
Qdenga, also known as TAK-003, is a live-attenuated tetravalent vaccine. This means it uses weakened forms of the dengue virus to help the immune system develop protection against all four dengue virus serotypes: DENV-1, DENV-2, DENV-3 and DENV-4.
The vaccine has been developed using recombinant DNA technology. According to the Health Ministry, genes that encode serotype-specific surface proteins are engineered into a dengue virus type-2 backbone.
Qdenga is supplied as a freeze-dried powder that must be reconstituted before use. It is administered through a subcutaneous injection, which means the dose is given under the skin.
The approved vaccination schedule consists of two doses of 0.5 ml each, administered three months apart.
Who Can Receive The Vaccine?
Qdenga has been approved in India for individuals aged four to 60 years. A key feature of the vaccine is that it can be administered regardless of whether the recipient has previously been infected with dengue.
Unlike Dengvaxia, an older dengue vaccine that is generally recommended only for people with evidence of a previous dengue infection, Qdenga does not require pre-vaccination blood screening.
This could make its use comparatively simpler, particularly in large-scale vaccination programmes, as eligible recipients would not need to undergo a test to confirm a past dengue infection before receiving the vaccine.
Further details on prescribing conditions, precautions and the groups prioritised for vaccination are expected to become clearer when the vaccine is commercially launched in India.
How Effective Is Qdenga?
Evidence supporting the vaccine includes the TIDES Phase III clinical trial, which involved more than 20,000 children and adolescents across eight dengue-endemic countries.
After about four-and-a-half years of follow-up, the vaccine showed around 84 per cent protection against dengue-related hospitalisation and approximately 61 per cent protection against virologically confirmed dengue.
The findings also indicated continued protection against severe disease among people with and without a previous dengue infection. However, the level of effectiveness varied across the four dengue serotypes.
The Indian regulatory review also included a Phase III safety and immunogenicity study covering participants aged four to 60 years in India.
Qdenga has received World Health Organization prequalification, indicating that it meets international requirements related to quality, safety and efficacy. This also allows global agencies such as UNICEF and the Pan American Health Organization to procure the vaccine.
Is Qdenga Safe?
According to the Health Ministry, the approval followed a “comprehensive scientific evaluation” of the vaccine’s quality, safety and efficacy.
Qdenga has already been approved in 42 countries, including the United Kingdom, European Union nations, Switzerland, Indonesia, Malaysia and Thailand. More than 24 million doses have been distributed globally.
The government said post-marketing surveillance in countries where the vaccine is already being used has shown a favourable safety profile, with no significant safety concerns identified.
As Qdenga is a live-attenuated vaccine, recipients should consult a doctor regarding eligibility, particularly if they have medical conditions, weakened immunity or are taking medicines that affect the immune system.
When Will Qdenga Be Available And What Will It Cost?
Takeda has not yet announced the vaccine’s commercial launch date or price in India. Initially, it could be made available through the private healthcare market, although details of its rollout remain awaited.
Takeda has also entered into a partnership with Hyderabad-based Biological E to manufacture up to 50 million doses annually. Local production could improve supply and potentially make the vaccine more affordable over time.
It is not yet clear whether Qdenga will eventually be included in a government vaccination programme.
The vaccine will complement, rather than replace, existing measures such as mosquito control, eliminating breeding sites, early diagnosis, disease surveillance and timely treatment. Its approval nevertheless represents a significant shift in India’s dengue strategy, particularly as seasonal outbreaks continue to place pressure on hospitals during the monsoon and post-monsoon periods.
