India's drug regulator has approved Takeda's QDENGA, making it the first dengue vaccine to receive regulatory clearance in the country.
QDENGA is administered as a two-dose vaccine and can be given regardless of prior dengue infection.
The approval comes as dengue cases continue to rise globally, with the WHO reporting 14.4 million cases and over 11,000 deaths in 2024, while India recorded more than 232,000 infections during the year.
India Clears First Dengue Vaccine; Here's What You Need to Know
Takeda's QDENGA has become the first dengue vaccine approved in India, offering protection without the need for pre-vaccination screening
Summary
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India's drug regulator has approved Takeda Pharmaceutical's dengue vaccine, QDENGA, making it the first dengue vaccine to receive regulatory clearance in the country, according to a Reuters report.
The approval marks a significant milestone in India's fight against one of the world's fastest-growing mosquito-borne diseases.
The Japanese drugmaker's India unit announced the approval on Monday. In 2024, Takeda India partnered with domestic vaccine manufacturer Biological E to expand production of the vaccine in the country.
Vaccine Targets Severe Dengue
Dengue continues to pose a major public health challenge globally. According to the World Health Organization (WHO), there were 14.4 million dengue cases and 11,201 deaths worldwide in 2024. India alone recorded 232,425 cases and 233 deaths during the year.
Takeda said QDENGA demonstrated 90.4% efficacy against dengue-related hospitalisations after 18 months, achieving the secondary endpoint of its clinical study.
Two-Dose Regimen Without Pre-Screening
QDENGA is administered as two 0.5 ml doses, given three months apart. Unlike some earlier dengue vaccines, it can be administered regardless of whether a person has previously been infected with dengue, eliminating the need for pre-vaccination screening.
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Reuters reported that this differentiates QDENGA from Sanofi's Dengvaxia, which has not been approved in India.
Dengvaxia is recommended only for individuals with a prior dengue infection because of concerns that it could increase the risk of severe disease in people who have never been infected.
Experts Highlight Benefits and Limitations
According to Reuters, infectious disease specialist Dr Divya K.S. of Apollo Hospitals said regulators may have sought additional post-marketing safety data before granting approval.
She noted that while QDENGA is expected to reduce the severity of dengue infections and lower hospitalisation rates, it is unlikely to prevent outbreaks as long as mosquito transmission continues.
Other Vaccine Developers Continue Research
The report noted that developing dengue vaccines remains a complex and time-consuming process due to safety considerations and the challenges involved in identifying suitable trial participants.
Hyderabad-based Indian Immunologicals Ltd (IIL), which is developing its own dengue vaccine candidate, is preparing to begin mid-stage clinical trials, Reuters reported, citing Managing Director K. Anand Kumar.
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Kumar said vaccine development takes time because researchers must address safety concerns associated with earlier dengue vaccines while ensuring clinical trial participants have not previously been infected with dengue or related viruses.