India has approved its first dengue vaccine after the Drug Controller General of India (DCGI) granted market authorisation to QDENGA, developed by Takeda Biopharmaceuticals India. The approval marks a significant milestone in the country’s efforts to combat dengue, a mosquito-borne disease that affects millions of people annually.
The vaccine has been approved for individuals aged 4 to 60 years and can be administered regardless of whether a person has previously been infected with dengue. Unlike some existing dengue vaccines, QDENGA does not require pre-vaccination screening, enabling eligible individuals to receive the vaccine without prior testing for past infection.
QDENGA is a live-attenuated tetravalent vaccine designed to protect against all four dengue virus serotypes, DENV-1, DENV-2, DENV-3 and DENV-4. The vaccine has already received regulatory approval in more than 40 countries, including the European Union, the United Kingdom, Brazil, Indonesia and Argentina.
The approval comes as India continues to face one of the world’s highest dengue burdens, with cases rising significantly over the past two decades due to urbanisation, climate change, changing mosquito habitats, and population growth.
According to the company, QDENGA has also received World Health Organization (WHO) prequalification, confirming that it meets international standards for quality, safety and effectiveness. The recognition also makes the vaccine eligible for procurement by global organisations such as UNICEF and the Pan American Health Organisation (PAHO).
Dengue is a mosquito-borne viral disease prevalent in more than 125 countries, with India accounting for nearly one-third of the global dengue burden.
