A Breakthrough in Public Health, ETPharma
Takeda has received approval to market its dengue vaccine, Qdenga, in India for individuals aged 4 to 60. This marks the first dengue vaccine approved in the country, supported by local clinical trials and a manufacturing partnership.
Why it matters
The introduction of a widely applicable dengue vaccine is a major public health milestone for India, potentially reducing the burden of the disease in endemic regions.
New Delhi: Japanese biopharma giant Takeda has secured approval to market its dengue prevention vaccine 'Qdenga' in India.The approval granted last week is supported by a local Phase 3 study involving 480 healthy adults, where the vaccine was found to be "tolerated, safe and immunogenic" across the target age group.This is the first-ever dengue vaccine approved for use in India and is recommended for the 4 - 60 age group. Takeda is required to conduct a "post marketing safety and effectiveness study in the local population within six months of introduction of the vaccine in the market."In India, the company had earlier announced a manufacturing partnership with Hyderabad-based Biological E to support Takeda's goal of producing 100 million doses annually by the end of this decade.Qdenga is designed to induce a strong immune response by generating detectable antibodies against all four dengue virus serotypes - DENV-1, DENV-2, DENV-3 and DENV-4.The…
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