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HealthIndia approves first dengue vaccine Qdenga for ages 4 to 60
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India's Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation for Qdenga, a recombinant live attenuated dengue vaccine developed by Takeda GmbH, making it the first dengue vaccine approved in the country. The vaccine is indicated for individuals aged 4 to 60 years and is administered as two subcutaneous doses of 0.5 ml each, three months apart. The Union Health Ministry stated the approval followed a comprehensive scientific evaluation of quality, safety, and efficacy under the Drugs and Cosmetics Act. Clinical studies included a pivotal Phase III trial in India and trials across eight countries. Qdenga has already received regulatory approval in 42 nations and WHO prequalification. Over 24 million doses have been distributed globally with a favourable safety profile. The approval is expected to complement India's existing vector control and disease management efforts under the National Vector Borne Disease Control Programme.
Source report
By: Bindu Shajan Perappadan Source: New Delhi
The Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation for India's first dengue vaccine — the Dengue Tetravalent Vaccine (Live, Attenuated), marketed as 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 aged 4 to 60 years.
"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," the Union Health Ministry said in a statement on Tuesday (July 21, 2026).
About Qdenga
- Type: Live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology.
- Production: Produced in Vero cells, with genes encoding serotype-specific surface proteins engineered into a dengue virus type-2 backbone.
- Contains: Genetically modified organisms (GMOs).
- Formulation: Supplied as a freeze-dried powder for reconstitution.
- Administration: Subcutaneous injection.
- Dosage schedule: Two doses of 0.5 ml each, administered at an interval of three months (0 and 3 months).
Evidence Supporting Approval
The Ministry stated that the approval is backed by an extensive global clinical development programme evaluating the vaccine's safety, immunogenicity, and efficacy across both dengue-endemic and non-endemic regions.
- Clinical studies included participants from more than eight countries, including Brazil, Thailand, and Sri Lanka.
- A pivotal Phase III safety and immunogenicity study was conducted in the Indian population, covering individuals aged 4 to 60 years.
- 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.
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.
Public Health Significance
"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," the Ministry said.
Published - July 21, 2026 11:39 am IST
Source
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India Approves First Dengue Vaccine Qdenga for Ages 4 to 60