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 Organisation (CDSCO) granting marketing authorisation for the Dengue Tetravalent Vaccine (Live, Attenuated) – Qdenga. Manufactured by Takeda GmbH, Germany, the vaccine will be imported by Takeda Biopharmaceuticals India Pvt. Ltd.

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

“The approval has been granted after a comprehensive scientific evaluation of the vaccine’s quality, safety and efficacy 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 tetravalent dengue vaccine developed using recombinant DNA technology. The vaccine is produced in Vero cells, with genes encoding serotype-specific surface proteins engineered into a 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 immunisation schedule consists of two doses of 0.5 ml each, administered at an interval of three months (0 and 3 months).

‘Supported by evidence’

The Ministry said that the approval is supported by evidence generated through an extensive global clinical development programme evaluating the vaccine’s safety, immunogenicity and efficacy across both dengue-endemic and non-endemic regions.

Clinical studies were conducted in participants from more than eight countries, including Brazil, Thailand and Sri Lanka. The evaluation also included a pivotal Phase III safety and immunogenicity study conducted in the Indian population covering 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 World Health Organization (WHO) prequalification. 

Favourable safety profile

Globally, more than 24 million doses of the vaccine have been distributed. Post-marketing surveillance data from countries where the vaccine is in use have demonstrated a favourable safety profile, with no significant safety concerns identified.

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