India has officially authorized the use of QDENGA, a dengue vaccine manufactured by Takeda Biopharmaceuticals, marking the first time a dengue vaccine has received regulatory approval in the country. The Drug Controller General of India (DCGI) cleared the vaccine for individuals aged 4 to 60, to be administered in two doses spaced three months apart, according to company reports.
Vaccine Efficacy and Clinical Data
The approval follows a global clinical development program conducted by Takeda, which included 19 Phase I, II, and III trials involving over 28,000 participants across both dengue-endemic and non-endemic regions. According to Takeda, the vaccine showed 80.2% efficacy against virologically confirmed dengue 12 months after the second dose.
Data regarding long-term protection indicates sustained results. At 18 months, the vaccine demonstrated 90.4% efficacy against dengue-related hospitalizations. Follow-up studies at 4.5 years showed an 84.1% efficacy rate against hospitalizations, with seven-year follow-up data suggesting continued protection across all four dengue serotypes. The vaccine is a live attenuated product, meaning it uses weakened versions of the virus to trigger an immune response without causing the disease.
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Unlike some previous vaccines, Takeda states that QDENGA does not require pre-vaccination screening, and can be administered to individuals regardless of their history of dengue infection.
The Public Health Burden of Dengue in India
India faces a significant challenge with the virus, accounting for approximately one-third of the global dengue burden. According to the National Centre for Vector Borne Diseases Control, the country recorded over 2 lakh cases in both 2023 and 2024. The World Health Organization (WHO) estimates that 100–400 million infections occur globally each year, with roughly half of the world’s population currently at risk.
The economic impact is substantial. A 2019 study published in the Journal of Infection and Public Health estimated the total cost of dengue in 2016 at US$5.71 billion. These costs are largely driven by non-fatal cases, which accounted for 85.7% of the total financial burden, while fatal cases contributed 14.3%.
Integration with Vector Control Measures
Public health officials emphasize that the vaccine will complement, rather than replace, existing strategies. Vipin M. Vashishtha, former national convener of the Indian Academy of Paediatrics’ Committee on Immunisation, noted in The Hindu that while the vaccine performs well against the DENV-2 serotype, its effectiveness against DENV-3 and DENV-4 may be lower in individuals who have not previously been exposed to the virus. Consequently, vector-control measures such as mosquito eradication remain essential to managing outbreaks.
The Ministry of Health has stated that the introduction of the vaccine will occur alongside ongoing surveillance, early diagnosis, and case management under the National Vector Borne Disease Control Programme.
Comparison of Pipeline Vaccines
The landscape for dengue prevention is shifting as other companies move through clinical trials. Panacea Biotec is currently conducting final Phase III trials for its vaccine, DengiAll. This single-dose candidate, which has enrolled over 10,000 volunteers, is overseen by the Indian Council of Medical Research and could potentially be ready for rollout as early as next year.
Global efforts have seen mixed results. In Brazil, the rollout of the Butantan-DV vaccine was suspended last month following reports of two suspicious deaths. Meanwhile, in the United States, Sanofi-Pasteur announced the discontinuation of its Dengvaxia vaccine for children, citing a lack of global market demand.
Frequently Asked Questions
Is the QDENGA vaccine available for all ages?
No, the DCGI has approved the vaccine specifically for individuals aged 4 to 60.
Does the vaccine prevent all dengue infections?
According to experts, the vaccine is more effective at reducing the severity of the illness and preventing hospitalizations rather than preventing all infections. Public health measures remain necessary to control transmission.
What is the price of the vaccine in India?
Takeda has not yet announced an official price for the vaccine in the Indian market.
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