India has authorized its inaugural vaccine for combating dengue, a significant stride in enhancing the nation’s defense against one of its rapidly spreading mosquito-borne illnesses. The Central Drugs Standard Control Organisation (CDSCO) has sanctioned the marketing of Qdenga, a live, weakened tetravalent dengue vaccine crafted by Takeda GmbH, Germany. This vaccine will be brought into the country by Takeda Biopharmaceuticals India Pvt. Ltd.
Qdenga, a live, weakened tetravalent vaccine produced using recombinant DNA technology, is structured to shield against all four dengue virus serotypes accountable for the ailment. Administered as a subcutaneous injection, the vaccine is supplied as a freeze-dried powder for reconstitution. The endorsed age group for this vaccine spans from 4 to 60 years, with a recommended immunization regimen comprising two 0.5 ml doses spaced three months apart.
The approval of Qdenga follows a thorough scientific assessment of its quality, safety, and effectiveness in accordance with the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945. The Health Ministry underscores that this endorsement is underpinned by data from a broad global clinical development initiative evaluating the vaccine’s safety, immunogenicity, and efficacy across dengue-endemic and non-endemic regions.
Qdenga has already garnered regulatory approval in 42 nations, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia, and Thailand. Additionally, it has received prequalification from the World Health Organization (WHO). With over 24 million doses distributed worldwide, post-marketing surveillance has revealed a favorable safety profile, with no notable safety issues reported. The vaccine is anticipated to complement existing strategies like vector control and disease surveillance under the National Vector Borne Disease Control Programme.
The Health Ministry stresses that vaccination is meant to fortify, not supplant, ongoing dengue prevention endeavors, which include eradicating mosquito breeding sites and advocating personal protective measures. The approval of Qdenga underscores the government’s dedication to ensuring prompt access to secure, efficient, and quality-assured vaccines through a robust, science-driven regulatory framework.
