India approves its first dengue vaccine: Know more about manufacturer, eligibility, dosage
The health ministry said the approval was supported by evidence generated through an extensive global clinical development programme evaluating the vaccine's safety, immunogenicity and efficacy across both dengue-endemic and non-endemic regions
The Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation for the Dengue Tetravalent Vaccine-Qdenga, manufactured by Takeda GmbH, Germany, and to be imported by Takeda Biopharmaceuticals India Pvt Ltd. This is the first dengue vaccine approved in the country for the prevention of dengue disease.
Qdenga vaccine contains genetically modified organisms (GMOs). It is supplied as a freeze-dried powder for reconstitution and is administered as a subcutaneous injection.
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 vaccine is indicated for the prevention of dengue disease in individuals 4 to 60 years of age. The recommended immunisation schedule consists of two doses of 0.5 ml each, administered at an interval of three months (0 and 3 months).
In a statement, the health ministry said the approval was supported by evidence generated through an extensive global clinical development programme evaluating the vaccine's safety, immunogenicity and efficacy across both dengue-endemic and non-endemic regions. Clinical studies were conducted in participants from more than eight countries, including Brazil, Thailand and Sri Lanka. The evaluation also included a pivotal Phase III safety and immunogenicity study conducted in the Indian population covering individuals aged 4 to 60 years.
The vaccine has already received regulatory approval in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand, and has also received World Health Organization (WHO) prequalification. 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.
