The government on Tuesday said Takeda Biopharmaceuticals India's dengue vaccine, QDENGA, has been granted market authorisation after a comprehensive scientific evaluation of its quality, safety and efficacy.This is the first dengue vaccine approved in the country for the prevention of the disease, the Health Ministry said.
Takeda Biopharmaceuticals India Pvt Ltd on Monday said it has received market authorisation from the drug regulator for its dengue prevention vaccine.
In a statement, the Health Ministry said the Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation for the dengue tetravalent vaccine manufactured by Takeda GmbH, Germany and to be imported by M/s Takeda Biopharmaceuticals India Pvt. Ltd.
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, it said.
QDENGA is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology.
The vaccine is produced in Vero cells, with genes encoding serotype-specific surface proteins engineered into a dengue virus type-2 backbone. The product contains genetically modified organisms (GMOs).It is supplied as a freeze-dried powder for reconstitution and is administered as a subcutaneous injection, the statement said.
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).
The approval is 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 statement said.
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, it said.
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 the World Health Organisation (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.
"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 statement said.