India has approved its first dengue vaccine, with the Drug Controller General of India (DCGI) granting market authorisation to vaccine QDENGA, developed by Takeda Biopharmaceuticals India.
The vaccine is approved for people aged 4 to 60 years and can be given regardless of whether a person has previously been infected with dengue. Unlike some dengue vaccines, QDENGA does not require pre-vaccination screening, allowing eligible individuals to receive the vaccine without first being tested for past dengue infection.
Takeda said the approval marks a major step in India's fight against dengue, a mosquito-borne disease that affects millions of people every year.
"Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India," said Mahender Nayak, Head of Intercontinental Markets at Takeda.
The company said long-term data collected over seven years showed that the vaccine continues to protect against dengue infection and hospitalisation caused by all four dengue virus serotypes.
The Indian approval is based on findings from Takeda's global clinical development programme, which included 19 Phase I, II and III clinical trials involving more than 28,000 participants in countries where dengue is common as well as regions where it is not. The decision was also supported by results from the Phase III DEN-302 clinical trial conducted in India, which assessed the vaccine's safety and immune response in people between 4 and 60 years of age. QDENGA is given as two injections of 0.5 ml, administered under the skin three months apart.
Takeda said India carries one of the world's highest dengue burdens, with all four virus serotypes circulating simultaneously in several parts of the country. "QDENGA is designed to protect against all four serotypes, regardless of prior exposure. Its approval represents an important step in strengthening India's comprehensive approach to dengue prevention, alongside vector control, surveillance, community awareness and other public health measures," said Goh Choo Beng, Medical Affairs Head for Takeda's Southeast Asia and India Cluster.
The company added that the World Health Organization (WHO) recommends QDENGA for use in dengue-endemic regions and supports its inclusion in public immunisation programmes in high-transmission areas without requiring pre-vaccination screening. QDENGA has also received WHO prequalification, confirming that it meets international standards for quality, safety and effectiveness. This also makes the vaccine eligible for procurement by global agencies such as UNICEF and the Pan American Health Organization (PAHO). Dengue is a mosquito-borne viral disease reported in more than 125 countries. According to the company, India accounts for nearly one-third of the global dengue burden, with rapid urbanisation, climate change and widespread mosquito breeding continuing to increase the risk of infection across the country.
Source: Times of India
– Agencies
