India has cleared its first dengue vaccine for public use, with the Drug Controller General of India (DCGI) granting market authorisation to Takeda Biopharmaceuticals India Pvt Ltd’s QDENGA. The approval marks a significant milestone in the country’s fight against dengue, a mosquito-borne disease that continues to affect millions every year.
The vaccine has been approved for individuals between the ages of 4 and 60 years. One of its key features is that it can be administered regardless of whether a person has previously had dengue. It also does not require any pre-vaccination screening, making it easier to roll out in areas where dengue is widespread.
Backed by global and Indian studies
According to the company, the approval is supported by findings from Takeda’s global clinical development programme, which included 19 Phase I, II and III trials involving more than 28,000 participants across dengue-endemic and non-endemic regions.
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The decision also takes into account results from the Phase III DEN-302 clinical trial conducted in India. The study evaluated the vaccine’s safety and immune response among participants aged 4 to 60 years.
“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,” Mahender Nayak, head of Intercontinental Markets at Takeda, said in a statement, as quoted by Moneycontrol.
He added that the latest seven-year data for the vaccine showed continued protection against dengue infection and dengue-related hospitalisation across all four dengue virus serotypes.
WHO recommendation and manufacturing plans
Takeda said QDENGA is recommended by the World Health Organisation (WHO) for use in dengue-endemic regions and can be introduced into immunisation programmes without requiring pre-vaccination testing. The vaccine has also received WHO prequalification, making it eligible for procurement through organisations such as UNICEF and the Pan American Health Organisation (PAHO).
Highlighting the need for broader protection, Goh Choo Beng, Medical Affairs Head, Southeast Asia & India Cluster at Takeda, was quoted as saying by News18, “QDENGA is designed to protect against all four serotypes, regardless of prior exposure.
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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,” according to Moneycontrol.
Takeda is also expanding production capacity in India. As reported by Reuters, the company has partnered with vaccine manufacturer Biological E to establish an annual production capacity of 50 million doses, supporting its long-term global manufacturing plans while addressing the growing burden of dengue in India.
FAQs:
Who is eligible to receive QDENGA in India?
The vaccine has been approved for individuals aged 4 to 60 years.
Is a dengue test required before taking QDENGA?
No. QDENGA can be administered without pre-vaccination testing.
