India approves first dengue vaccine for persons aged 4-60, Pg14

Key Highlights:

• The Drug Controller General of India (DCGI) has granted market authorization to QDENGA (TAK-003), making it India's first approved dengue vaccine.
• Developed by Takeda Biopharmaceuticals India, the vaccine is approved for individuals aged 4 to 60 years.
• QDENGA is a live-attenuated tetravalent vaccine designed to protect against all four dengue virus serotypes.
• It is administered as a two-dose regimen, three months apart, and does not require pre-vaccination screening.
• India accounts for nearly one-third of the global dengue burden, with reported cases increasing significantly over the past two decades.

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Detailed Insights:

• The approval of QDENGA addresses a critical public health challenge in India, where dengue incidence has risen substantially.
• The vaccine's efficacy was demonstrated in global clinical trials, including a pivotal Phase III study with over 20,000 participants.
• QDENGA showed 80.2% efficacy against virologically confirmed dengue and 90.4% against dengue-related hospitalization.
• Its ability to be administered irrespective of prior dengue infection simplifies vaccination strategies and broadens accessibility.
• This approval aligns India with 43 other countries across Asia, Latin America, and Europe where QDENGA is already available.

Scientific/Technical Concepts Involved:

• Live-attenuated vaccine: A vaccine made from weakened, but still living, forms of the virus or bacteria.
• Tetravalent vaccine: A vaccine designed to protect against four different strains or serotypes of a pathogen.
• Serotype: A distinct variation within a species of bacteria or virus, identifiable by its unique surface antigens.