India Approves First Dengue Vaccine for People Aged 4 to 60

India has approved its first vaccine for the prevention of dengue, marking a major milestone in the country's fight against one of its most widespread mosquito-borne diseases. The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has granted marketing authorisation to Qdenga®, a tetravalent dengue vaccine manufactured by Takeda GmbH, Germany, and to be imported by Takeda Biopharmaceuticals India Pvt. Ltd.

The approval follows a detailed scientific review of the vaccine's quality, safety and effectiveness under the provisions of the Drugs and Cosmetics Act, paving the way for a new preventive tool alongside existing dengue control measures.

Vaccine designed to protect against all four dengue virus types

Qdenga® is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology. It is designed to protect against all four dengue virus serotypes by using a dengue virus type-2 backbone engineered with serotype-specific surface proteins.

The vaccine is supplied as a freeze-dried powder that is reconstituted before administration and is given as a subcutaneous injection. It has been approved for individuals aged 4 to 60 years, with the recommended schedule consisting of two 0.5 ml doses administered three months apart.

Approval backed by global and Indian clinical studies

The regulatory approval is supported by an extensive international clinical development programme that evaluated the vaccine's safety, immune response and effectiveness in both dengue-endemic and non-endemic regions. Clinical trials included participants from more than eight countries, including Brazil, Thailand and Sri Lanka, while a key Phase III study was also conducted in India involving volunteers between 4 and 60 years of age. These studies formed an important part of the evidence reviewed before approving.

The vaccine has already received regulatory clearance in 42 countries, including members of the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand. It has also received World Health Organization (WHO) prequalification, and more than 24 million doses have been distributed globally. Post-marketing safety data from countries using the vaccine have not identified any significant safety concerns.

New vaccine adds to India's dengue control strategy

Health authorities said the approval is expected to strengthen India's overall dengue prevention efforts by complementing existing measures such as mosquito control, disease surveillance, early diagnosis and clinical 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 through a science-based regulatory system. The approval of Qdenga® represents an important addition to India's public health response as the country continues to tackle the growing burden of dengue.