New Delhi, July 20: In a significant milestone for India’s public health system, the Drug Controller General of India (DCGI) has granted market authorisation to Takeda Biopharmaceuticals India’s QDENGA (TAK-003), making it the country’s first approved vaccine for the prevention of dengue.
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The vaccine has been approved for individuals aged 4 to 60 years and is expected to strengthen India’s fight against dengue, a mosquito-borne disease that continues to affect lakhs of people every year.
QDENGA is a live-attenuated tetravalent vaccine developed to provide protection against all four dengue virus serotypes. It is administered in a two-dose schedule, with the second dose given three months after the first.
One of the vaccine’s key advantages is that it can be administered regardless of whether a person has previously been infected with dengue, eliminating the need for pre-vaccination screening.
The approval comes at a time when dengue remains a major public health concern in India. Reported cases have increased sharply over the past two decades, with the country accounting for nearly one-third of the global dengue burden. Health experts believe the actual number of infections is significantly higher than officially reported.
According to Takeda, the approval is backed by an extensive global clinical development programme involving 19 Phase I, II and III studies with more than 28,000 participants from dengue-endemic and non-endemic countries.
The company’s pivotal Phase III TIDES (DEN-301) trial, which enrolled over 20,000 participants across eight dengue-endemic nations, showed promising results. The vaccine demonstrated 80.2 per cent efficacy against laboratory-confirmed dengue one year after the second dose and 90.4 per cent efficacy in preventing dengue-related hospitalisation after 18 months. Long-term follow-up also indicated sustained protection against severe dengue and hospitalisation.
The Indian approval was further supported by a Phase III clinical trial involving participants between 4 and 60 years of age, where the vaccine was found to be safe, well tolerated and capable of generating a strong immune response in children, adolescents and adults.
QDENGA has already received regulatory approval in 43 countries across Asia, Europe and Latin America. More than 32 million doses have been distributed through public and private immunisation programmes. The vaccine has also received World Health Organization (WHO) prequalification and is recommended by the WHO for use in dengue-endemic regions with high transmission.
Takeda said it will work closely with Indian regulatory authorities, healthcare professionals and public health agencies to facilitate the rollout and availability of the vaccine across the country in the coming months.
The approval marks a major step forward in India’s efforts to reduce dengue-related illness and hospitalisations, offering a new preventive tool against one of the country’s most persistent vector-borne diseases.
