CDSCO approves India’s first dengue vaccine Qdenga for individuals aged 4–60 years

The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has granted marketing authorisation for the Dengue Tetravalent Vaccine (Live, Attenuated) – Qdenga, manufactured by Takeda GmbH, Germany, and to be imported by Takeda Biopharmaceuticals India. According to the Press Information Bureau (PIB), this is the first dengue vaccine approved in India for the prevention of dengue disease.

According to PIB, the approval followed a 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.

PIB stated that Qdenga is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology. According to the release, 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) and is supplied as a freeze-dried powder for reconstitution. It is administered as a subcutaneous injection.

According to PIB, the vaccine is indicated for the prevention of dengue disease in individuals aged 4 to 60 years. The recommended immunisation schedule comprises two doses of 0.5 ml each, administered three months apart.

The approval is supported by evidence generated through a clinical development programme evaluating the vaccine’s safety, immunogenicity and efficacy across dengue-endemic and non-endemic regions, PIB stated. Clinical studies were conducted in participants from more than eight countries, including Brazil, Thailand and Sri Lanka. According to the release, the evaluation also included a Phase III safety and immunogenicity study conducted in the Indian population involving individuals aged 4 to 60 years.

According to PIB, the vaccine has 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. The release stated that more than 24 million doses of the vaccine have been distributed globally. Post-marketing surveillance data from countries where the vaccine is in use have demonstrated a favourable safety profile, with no significant safety concerns identified.

PIB stated that the approval of India’s first dengue vaccine is expected to complement vector control, surveillance, early diagnosis and case management measures implemented under the National Vector Borne Disease Control Programme.

According to PIB, the Ministry of Health and Family Welfare remains committed to ensuring access to vaccines and medicines through a science-based regulatory framework.