CDSCO clears recombinant live attenuated dengue vaccine for ages 4 to 60 years

India has approved its first dengue vaccine, with the Central Drugs Standard Control Organization (CDSCO) granting marketing authorization for Dengue Quadruple Vaccine (Live, Attenuated) – Qdenga. The vaccine produced by Takeda GmbH, Germany, and Takeda Biopharmaceuticals India Pvt. It will be imported by . Ltd.

The vaccine is indicated for the prevention of dengue fever in individuals aged 4 to 60 years.

“The approval was granted following a comprehensive scientific evaluation of the quality, safety and effectiveness of the vaccine in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945,” said a statement issued by the Union Health Ministry on Tuesday, July 21, 2026.

What is Qdenga?

Qdenga is a live, attenuated quadrivalent dengue vaccine developed using recombinant DNA technology. The vaccine is produced in Vero cells in which genes encoding serotype-specific surface proteins are translated into the dengue virus type-2 backbone.

The product contains genetically modified organisms (GMOs).

It is supplied as a freeze-dried powder for reconstitution and is administered as a subcutaneous injection.

The recommended vaccination schedule consists of two doses of 0.5 ml each, administered three months apart (0 and 3 months).

‘Supported by evidence’

The ministry said the approval was supported by evidence obtained through a comprehensive global clinical development program that evaluated the safety, immunogenicity and efficacy of the vaccine in both dengue-endemic and non-endemic areas.

Clinical studies were conducted with participants from more than eight countries, including Brazil, Thailand and Sri Lanka. The evaluation also included a pivotal Phase III safety and immunogenicity study in the Indian population involving individuals aged 4 to 60 years.

The vaccine has already received regulatory approval in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand, and has also received pre-qualification from the World Health Organization (WHO).

Appropriate security profile

More than 24 million vaccine doses have been distributed worldwide. Post-marketing surveillance data from countries where the vaccine was used revealed a positive safety profile, with no significant safety concerns identified.

“The approval of the country’s first dengue vaccine marks a significant milestone in India’s public health response to dengue and is expected to complement the ongoing vector control, surveillance, early detection and case management measures implemented under the National Vector-Borne Disease Control Programme,” the ministry said.