India approves first-ever dengue vaccine Qdenga: Who can get it and how it works

The vaccine has been manufactured by Takeda GmbH, Germany, and will be imported into India by Takeda Biopharmaceuticals India Pvt. Ltd.

"This is the first dengue vaccine approved in the country for the prevention of dengue disease," the Ministry of Health and Family Welfare said in a statement.

The approval follows 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.

What is Qdenga?

Qdenga is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology.

It is produced in Vero cells, with genes encoding serotype-specific surface proteins engineered into a dengue virus type-2 backbone. The vaccine contains genetically modified organisms (GMOs) and is supplied as a freeze-dried powder that is reconstituted before being administered as a subcutaneous injection.

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

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

Clinical trials and global use

According to the government, the approval is backed by evidence from an extensive global clinical development programme evaluating the vaccine's safety, immunogenicity and efficacy in both dengue-endemic and non-endemic regions.

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

Qdenga has already received regulatory approval in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand. It has also received World Health Organization (WHO) prequalification.

More than 24 million doses of the vaccine have been distributed worldwide. According to the government, post-marketing surveillance data from countries where the vaccine is in use have shown a favourable safety profile, with no significant safety concerns identified.

The approval of India's first dengue vaccine marks a significant milestone in the country's public health response to the mosquito-borne disease. It is expected to complement existing dengue control measures, including vector control, surveillance, early diagnosis and case management under the National Vector Borne Disease Control Programme.

The Ministry of Health and Family Welfare said it remains committed to ensuring timely access to safe, effective and quality-assured vaccines and medicines through a robust, science-based regulatory framework.