India has taken a major step forward in its long fight against dengue. Qdenga, a vaccine designed to prevent the disease, has now been approved to be sold in the country. The announcement was made on Monday by Takeda Biopharma India Private Limited, the company behind the vaccine. What makes this significant is that it becomes the first dengue vaccine to receive approval in India, and it can be given to people between the ages of 4 and 60 to protect them from the infection.
The Indian unit of Takeda, the large Japanese biopharmaceutical company, shared an important detail in its statement. According to the company, no test is required before administering the vaccine. This means it can be safely given to a person whether or not they have had dengue in the past, without any prior screening.
Already approved in 43 countries
Qdenga is not an entirely new vaccine. It was first launched in 2022, and since then it has secured approval in 43 countries around the world. More than 32 million doses have already been distributed globally. Mahendra Naik, Head of Intercontinental Markets at Takeda, described the Indian approval as "an important step towards strengthening dengue prevention."
Naik added that seven years of recent data on Qdenga are reassuring. The figures show that the vaccine not only protects against dengue infection but also consistently prevents the situation where a patient needs to be hospitalised. Crucially, this protection works against all four serotypes of the dengue virus.
Tested on more than 28,000 people
The approval in India did not come easily. It rests on solid results from the company's global clinical development programme. Under this programme, 19 clinical trials were carried out on more than 28,000 people, across both high-burden and low-burden dengue regions. These trials spanned all three phases, phase 1, 2 and 3. The approval was further strengthened by data from a Phase 3 clinical trial (DEN-302) conducted on Indian participants. That trial closely examined the safety and immunogenicity, the ability to boost the body's disease resistance, of the vaccine in people aged 4 to 60.
Why this vaccine matters for India
Dengue has been a big and long-standing problem in India. What makes it worse is that in many parts of the country all four serotypes of the dengue virus have been found spreading together, making the illness even more dangerous. According to the company, the World Health Organization (WHO) recommends the use of Qdenga in high-burden areas and supports including it in public vaccination programmes in high-transmission regions, without the need for prior screening. The vaccine has also received prequalification from the WHO, which confirms that it meets global standards of quality, safety and effectiveness.
