DCGI approved India's first dengue vaccine 'Qdenga'

Takeda's tetravalent dengue vaccine, TAK-003 (called 'Qdenga'), has recently received approval from the Subject Expert Committee (SEC) under the Drugs Controller General of India (DCGI) for use in people aged 4 to 60 years.

This is an important milestone in the country's fight against a disease that causes millions of infections and thousands of hospitalizations every year, especially among children.

Several benefits are associated with TAK-003. It has been evaluated in large global trials involving more than 28,000 participants, and it has already been approved in more than 40 countries.

This vaccine has also shown good safety and, most importantly, has provided strong protection against severe dengue and hospitalization, both of which are outcomes that matter the most in clinical practice.

Qdenga vaccine

TAK-003 (Qdenga) is a dengue vaccine developed by the Japanese pharmaceutical company Takeda. It is a tetravalent dengue vaccine, designed to provide protection against all four serotypes of the dengue virus (DENV-1 to DENV-4).

It works very well against the DENV-2 serotype, as it was developed based on DENV-2, and also works quite well against DENV-1, but its effectiveness appears to be lower against DENV-3 and DENV-4, especially in people who have never had dengue infection before.

This is not just a theoretical concern. The epidemiology of dengue in India is changing, and reports of DENV-3 becoming more dominant in many regions are increasing. Recent data from India also show that all four serotypes of dengue continue to circulate simultaneously; in many regions, DENV-2 is still the most widespread, but DENV-3 is also contributing significantly and increasing in cases.

Indian vaccine pipeline

India's dengue vaccine pipeline is progressing rapidly; it includes an indigenous vaccine named 'DengiAll', developed by Panacea Biotec in collaboration with the Indian Council of Medical Research, and it is currently undergoing large-scale phase III clinical trials.

Based on the NIH's TV003 platform, DengiAll is a single-dose vaccine designed to provide more balanced protection against all four serotypes.

Dengvaxia: the world's first dengue vaccine

Dengvaxia is the world's first vaccine approved for the prevention of dengue fever; it is a virus that is mainly transmitted by mosquitoes in tropical and subtropical regions.

Saint Louis University holds the patent for this vaccine, which was developed in the year 1997 by Thomas Chambers, M.D.; at that time, he was an Associate Professor of Molecular Microbiology and Immunology.

Although Mexico is the first country to approve the use of the dengue vaccine, regulatory boards in other countries where dengue fever is endemic are considering licensing this vaccine.

Viral infection: Dengue

Dengue is a viral infection that spreads to humans through the bite of the Aedes mosquito. Its common symptoms include high fever, headache, joint/muscle pain, and rashes on the body. These symptoms last for 1–2 weeks, and in severe cases (dengue hemorrhagic fever), the patient may need to be hospitalized.