India approves dengue vaccine QDENGA
India approves dengue vaccine QDENGA
India Approves First Dengue Vaccine QDENGA
India has approved its first dengue vaccine, QDENGA, after receiving clearance from the Drug Controller General of India (DCGI). The vaccine, developed by Japan's Takeda Pharmaceutical, is designed to protect against all four dengue virus serotypes and can be administered to individuals aged 4 to 60 years, regardless of previous dengue infections.
The approval comes at a critical time, as India and other South Asian countries are grappling with a surge in dengue infections. In Sri Lanka, health authorities reported 2,652 new cases on a single day, bringing the total to 76,044 cases this year, with at least 53 deaths. Bangladesh is also experiencing a major outbreak, with over 9,000 cases and 30 deaths, putting a significant strain on its health system.
Dengue is a mosquito-borne disease that can cause severe symptoms, including fever, muscle pain, and in severe cases, shock and internal bleeding. While mortality rates are relatively low, outbreaks can place a substantial burden on health systems. The global threat posed by dengue has been rising due to climate change, urbanization, and international travel, which aid the spread of the mosquitoes that transmit the disease.
QDENGA is a live-attenuated tetravalent vaccine that has been approved in over 40 countries and is pre-qualified by the World Health Organization (WHO). The vaccine has undergone extensive clinical trials, including a Phase III study in India, which demonstrated its safety and efficacy in adults and children. According to Takeda, the vaccine has shown an efficacy of 80.2% against virologically confirmed dengue one year after the second dose, and 90.4% efficacy against dengue-related hospitalization after 18 months.
Dr. Suresh F Shah, founder and lead pediatrician of Sparsh Children's Hospital, noted that the vaccine's ability to generate immunity against all four dengue virus serotypes is particularly important for India, where multiple serotypes circulate simultaneously and secondary infections are often associated with severe disease. However, Dr. Shah also emphasized that vaccination must remain one layer within integrated prevention, and that source reduction, personal protection, and early recognition of warning signs are still essential.
Shikha Taneja Malik, Senior Scientific Affairs Manager at the Drugs for Neglected Diseases initiative, highlighted the importance of a locally manufactured, affordable vaccine in reducing severe cases and hospital strain. However, she also noted that there are still specific populations, such as pregnant women, newborns, and older adults, who would not benefit from this vaccine.
Takeda has partnered with Indian vaccine manufacturer Biological E to manufacture up to 50 million doses of QDENGA annually, supporting the company's target of producing 100 million doses globally each year by the end of the decade. The vaccine is expected to be commercially available in India during the first half of next year, subject to regulatory and supply chain processes being completed.
Dr. Eng Eong, a dengue expert and professor at Duke-NUS in Singapore, emphasized the need for India and other dengue-affected countries to move beyond strategies reliant on vector control. "A licensed dengue vaccine in India adds an important piece to the very limited public health arsenal to combat dengue," he said.
