India approved its first dengue vaccine, Qdenga, for individuals aged 4–60 after the CDSCO granted marketing authorization following global and local clinical trials. The live-attenuated tetravalent vaccine, developed by Takeda, is effective against all four dengue serotypes and requires two doses three months apart.
The Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation to India’s first dengue vaccine, Qdenga®, for individuals aged 4 to 60 years, marking a significant milestone in the country’s public health response to dengue. Developed by Takeda GmbH, Germany, the vaccine is imported and marketed in India by Takeda Biopharmaceuticals India Pvt.
Approval Process and Clinical Evidence
Qdenga is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology. It is manufactured in Vero cells using a dengue virus type-2 backbone engineered with serotype-specific surface proteins. The vaccine is administered as a subcutaneous injection in two doses of 0.5 ml each, three months apart. The approval was supported by extensive global clinical evidence, including a pivotal Phase III study conducted in India involving 480 participants, as reported by ThePrint.
Clinical trials involving over 28,000 participants, including in countries where dengue is common as well as regions where it is not, demonstrated the vaccine’s safety and efficacy. Long-term data from seven years of global use showed continued protection against dengue infection and hospitalisation, with 90% efficacy against hospitalisation 18 months after the final dose and 84% efficacy 4.5 years later, according to The Times of India. The vaccine’s efficacy does not depend on prior dengue infection, unlike some other dengue vaccines, as noted by Mahender Nayak, Head of Intercontinental Markets at Takeda.
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,
Nayak said. Goh Choo Beng, Medical Affairs Head for Takeda’s Southeast Asia and India Cluster, added that the vaccine’s design protects against all four serotypes regardless of prior exposure, complementing existing public health measures like vector control and surveillance.
Global Recognition and Distribution
Qdenga has received World Health Organization (WHO) prequalification, enabling its procurement by global agencies such as UNICEF and PAHO. It has been approved in 43 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia, and Thailand, as stated by Ddindia. The vaccine’s approval in India follows similar regulatory pathways in other regions, with the WHO recommending its use in dengue-endemic areas without requiring pre-vaccination screening.
The Ministry of Health and Family Welfare highlighted that Qdenga’s approval aligns with India’s National Vector Borne Disease Control Programme, which includes vector control, surveillance, and early diagnosis. The vaccine’s availability is expected to reduce the burden of dengue, a mosquito-borne disease that affects millions annually. India accounts for nearly one-third of the global dengue burden, with rapid urbanisation and climate change exacerbating transmission risks, according to The Times of India.
Future Implications and Ongoing Developments
While Qdenga is now available in India, another dengue vaccine, DengiAll by Panacea Biotech, is undergoing trials and may seek market approval soon. The introduction of Qdenga is seen as a critical addition to India’s public health arsenal, particularly in regions where all four dengue serotypes are prevalent. The vaccine’s two-dose schedule and lack of pre-vaccination testing simplify implementation, potentially increasing uptake among at-risk populations.
Experts emphasize that Qdenga’s approval underscores the importance of evidence-based prevention strategies. Dengue is a growing public health challenge, and India needs sustained, evidence-based prevention. The latest seven-year data for QDENGA show continued protection against dengue infection and hospitalisation,
said Mahendra Nayak, as quoted by ThePrint. The vaccine’s global success and local trials position it as a key tool in India’s fight against a disease that continues to evolve with changing environmental and demographic factors.
