New Delhi, July 22: India has approved QDENGA, the country’s first dengue vaccine, marking a significant milestone in the nation’s efforts to prevent dengue and strengthen public health.
The Union Health Ministry said Takeda Biopharmaceuticals India Pvt. Ltd. has received market authorisation for QDENGA, a tetravalent dengue vaccine manufactured by Takeda GmbH, Germany, following a comprehensive scientific evaluation of its quality, safety and efficacy.
According to the Ministry, the Central Drugs Standard Control Organisation (CDSCO) granted approval under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
QDENGA is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology. It is produced in Vero cells and contains genetically modified organisms (GMOs). The vaccine is supplied as a freeze-dried powder for reconstitution and is administered as a subcutaneous injection.
The vaccine is approved for individuals aged 4 to 60 years. The recommended vaccination schedule consists of two doses of 0.5 ml each, administered three months apart.
The approval is backed by data from an extensive global clinical development programme that assessed the vaccine’s safety, immunogenicity and efficacy in both dengue-endemic and non-endemic regions.
Clinical trials involved participants from more than eight countries, including Brazil, Thailand and Sri Lanka. A pivotal Phase III study was also conducted in India among individuals aged 4 to 60 years to evaluate the vaccine’s safety and immune response.
QDENGA has already received regulatory approval in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand. It has also received World Health Organization (WHO) prequalification.
According to the Health Ministry, more than 24 million doses of the vaccine have been distributed globally. Post-marketing surveillance has shown a favourable safety profile, with no major safety concerns reported.
The Ministry said the approval of QDENGA is expected to complement existing dengue prevention strategies, including vector control, surveillance, early diagnosis and case management under the National Vector Borne Disease Control Programme.
