New Delhi, Jul 21: India has approved its first dengue vaccine, with the Central Drugs Standard Control Organisation (CDSCO) granting market authorisation to Takeda Biopharmaceuticals India’s QDENGA, the Union Health Ministry announced on Tuesday.
The ministry said the vaccine received approval after a comprehensive scientific evaluation of its quality, safety and efficacy under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
Manufactured by Takeda GmbH, Germany, and to be imported by Takeda Biopharmaceuticals India Pvt. Ltd., QDENGA is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology.
The vaccine is indicated for the prevention of dengue in individuals aged 4 to 60 years. It will be administered as two subcutaneous doses of 0.5 ml each, given three months apart.
According to the Health Ministry, the approval is backed by extensive global clinical trials assessing the vaccine’s safety, immunogenicity and efficacy in both dengue-endemic and non-endemic countries. The evaluation also included a pivotal Phase III clinical study in India involving participants between 4 and 60 years of age.
Clinical studies were conducted in more than eight countries, including Brazil, Thailand and Sri Lanka.
The ministry said QDENGA has already been approved in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand, and has also received World Health Organization (WHO) prequalification. More than 24 million doses have been distributed globally, with post-marketing surveillance indicating a favourable safety profile.
Describing the approval as a major milestone, the Health Ministry said the vaccine is expected to strengthen India’s fight against dengue by complementing existing measures such as vector control, disease surveillance, early diagnosis and case management under the National Vector Borne Disease Control Programme.
