India Approves First Dengue Vaccine for Public Use

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 vaccine is approved for individuals aged between 4 and 60 years and can be administered regardless of whether they have previously been infected with dengue. Unlike some existing dengue vaccines, QDENGA does not require pre-vaccination screening, allowing eligible individuals to receive the vaccine without prior testing for past infection.

Takeda described the approval as a significant milestone in India's efforts to combat dengue, a mosquito-borne disease that affects millions of people annually.

According to the company, QDENGA has been approved in 43 countries since its global launch in 2022, with more than 32 million doses distributed worldwide.

Long-term data collected over seven years indicate that the vaccine provides sustained protection against dengue infection and dengue-related hospitalisation caused by all four dengue virus serotypes.

The approval in India is based on Takeda's global clinical development programme, which included 19 Phase I, II and III clinical trials involving more than 28,000 participants across dengue-endemic and non-endemic regions. It was also supported by findings from the Phase III DEN-302 clinical trial conducted in India, which evaluated the vaccine's safety and immune response in people aged 4 to 60 years.

QDENGA is administered as two 0.5 ml doses given under the skin, three months apart.

Takeda noted that India bears one of the world's highest dengue burdens, with all four virus serotypes circulating in several regions. The company said the vaccine is designed to protect against all four serotypes regardless of prior exposure and complements existing dengue prevention measures, including mosquito control, disease surveillance, public awareness and other public health initiatives.

The World Health Organization (WHO) recommends QDENGA for use in dengue-endemic areas and supports its inclusion in immunisation programmes in high-transmission regions without requiring pre-vaccination screening. The vaccine has also received WHO prequalification, making it eligible for procurement by international agencies, including UNICEF and the Pan American Health Organization (PAHO).

Dengue is a mosquito-borne viral disease reported in more than 125 countries. According to Takeda, India accounts for nearly one-third of the global dengue burden, with rapid urbanisation, climate change and widespread mosquito breeding contributing to the continued rise in infections.

Source: Times of India / Agencies