New Delhi, July 21 (IANS): India has approved its first vaccine for the prevention of dengue, with the Central Drugs Standard Control Organisation (CDSCO) granting marketing authorisation to Qdenga, a live, attenuated tetravalent dengue vaccine developed by Takeda GmbH, Germany. The vaccine, which will be imported by Takeda Biopharmaceuticals India Pvt. Ltd., is approved for individuals aged 4 to 60 years and is designed to protect against all four dengue virus serotypes. Administered as a subcutaneous injection, the recommended schedule consists of two doses of 0.5 ml each given three months apart. The approval follows a comprehensive scientific evaluation of the vaccine’s quality, safety and efficacy under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Qdenga is developed using recombinant DNA technology and is supplied as a freeze-dried powder for reconstitution before administration. According to the Health Ministry, the approval is supported by extensive global clinical studies conducted across more than eight countries, including Brazil, Thailand and Sri Lanka, along with a pivotal Phase III trial in India involving participants aged 4 to 60 years. The vaccine 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 and no significant safety concerns. The government said the vaccine will complement existing dengue control measures such as vector control, disease surveillance, early diagnosis and case management under the National Vector Borne Disease Control Programme, while emphasising that vaccination does not replace the need to eliminate mosquito breeding sites and adopt personal protective measures.