QDENGA approved as India’s first dengue vaccine: Two-dose shot cleared for ages 4-60

India has approved its first dengue vaccine, marking a major step in the country's efforts to prevent one of its most widespread mosquito-borne diseases.

The Drug Controller General of India (DCGI) has granted market authorisation to QDENGA (TAK-003), a live-attenuated tetravalent vaccine developed by Takeda Biopharmaceuticals. The vaccine has been approved for use in people aged 4 to 60 years, as per Reuters.

The approval comes as India continues to account for a significant share of the global dengue burden, with millions of infections reported each year.

No prior dengue test required

One of the key features of QDENGA is that it can be administered regardless of whether a person has previously been infected with dengue.

Unlike some earlier dengue vaccines that required individuals to undergo blood tests to confirm prior exposure to the virus, QDENGA does not require pre-vaccination screening, making it easier to roll out on a wider scale.

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The vaccine is given as two subcutaneous doses, with the second dose administered three months after the first.

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Backed by global and Indian clinical trials

The vaccine's approval follows extensive clinical testing conducted both internationally and in India.

Takeda's global clinical development programme included 19 Phase I, II and III trials involving more than 28,000 participants, with studies showing long-term protection against dengue-related hospitalisation.

In India, the vaccine was evaluated through the Phase III DEN-302 trial, which assessed its safety and immune response among children, adolescents and adults. The study found the vaccine to be safe, well tolerated and capable of generating a strong immune response across different age groups.

Manufacturing plans in India

To support vaccine supply, Takeda has partnered with Hyderabad-based Biological E. Limited to manufacture QDENGA in India.

The company plans to produce up to 50 million doses annually, a move expected to improve vaccine availability and support future public immunisation programmes.

QDENGA has already been approved in more than 40 countries, including the European Union, the United Kingdom and Brazil. It is designed to provide protection against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3 and DENV-4).

India also developing indigenous vaccine

Alongside QDENGA, India is also working on its own dengue vaccine.

DengiAll, a tetravalent vaccine candidate being developed by Panacea Biotec in collaboration with the Indian Council of Medical Research (ICMR), is currently undergoing Phase III clinical trials and is expected to be available in the coming years.

The approval of QDENGA marks India's first licensed dengue vaccine and adds a preventive tool to existing efforts that have largely relied on mosquito control measures and supportive medical care.