India all set to get its first dengue vaccine, Pg12

Key Highlights:

• The Drug Controller General of India (DCGI) has approved Qdenga, developed by Takeda Biopharmaceuticals India, making it India's first dengue vaccine.
• The vaccine is designed to protect against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, DENV-4) and is approved for individuals aged 4 to 60 years.
• Qdenga can be administered as a two-dose regimen, three months apart, without requiring prior dengue exposure or pre-vaccination testing.
• Takeda has partnered with Hyderabad-based Biological E to manufacture up to 50 million doses annually in India.
• India accounts for nearly one-third of the global dengue burden, with reported cases increasing 11-fold over the past two decades.

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Detailed Insights:

• The approval of Qdenga marks a significant shift in India's public health strategy from reactive vector control to preventive measures against dengue.
• Qdenga is a live-attenuated tetravalent vaccine, meaning it uses weakened forms of all four dengue virus serotypes to induce immunity.
• Clinical trials have shown Qdenga to be 80.2% effective against confirmed dengue cases one year after the second dose and 90.4% effective against dengue-related hospitalizations after 18 months.
• Since its global launch in 2022, Qdenga has received regulatory approvals in 43 countries, with over 32 million doses distributed worldwide.
• The partnership with Biological E aims to enhance local production capacity and ensure sustainable access to the vaccine in India and other endemic countries.
• The DCGI, which heads the Central Drugs Standard Control Organization (CDSCO), is responsible for approving licenses for specific categories of drugs and vaccines in India.

Scientific/Technical Concepts Involved:

• Dengue: A mosquito-borne viral disease caused by the dengue virus, belonging to the Flavivirus genus.
• Serotypes: Distinct genetic variations of a virus; the dengue virus has four main serotypes (DENV-1, DENV-2, DENV-3, DENV-4).
• Live-attenuated vaccine: A vaccine that uses a weakened, but living, form of the virus to stimulate an immune response.
• Tetravalent vaccine: A vaccine designed to protect against four different serotypes or strains of a pathogen.