New Delhi: By 2026, India could have its first approved dengue vaccine - and for millions who dread every mosquito bite during the monsoon, it could be a game-changer.
Japanese pharmaceutical giant Takeda is preparing to roll out its dengue vaccine, TAK-003, in India through a local manufacturing partnership with Hyderabad-based Biological E (Bio E). The launch, slated for next year, is contingent on final regulatory approvals and aligns with the Indian government’s ‘Make in India’ initiative to boost local production of critical healthcare solutions.
In a statement, Takeda said, “Our regulatory application is currently under review, and we will launch in India upon receipt of all requisite approvals from the regulatory authorities.” The Central Drugs Standard Control Organisation (CDSCO) has already cleared Takeda to conduct trials of TAK-003 in India, a crucial step toward its final approval.
Globally, TAK-003 has seen rapid uptake. Approved in 40 countries—including Indonesia, Thailand, Argentina, Brazil, and the European Union (EU)—the vaccine received prequalification from the World Health Organization (WHO) in May 2024, marking it as a safe and effective option for widespread use. Since its commercial debut in 2023, over 10 million doses have been administered.
Importantly, TAK-003 offers a critical advantage over Sanofi’s Dengvaxia, the first dengue vaccine to receive WHO prequalification. While Dengvaxia is only recommended for individuals aged 6 to 45 with confirmed prior dengue infection (due to safety concerns in those without prior exposure), TAK-003 is approved for use regardless of prior dengue infection. This broader applicability makes it a highly promising tool for India, where dengue is a recurring and growing public health challenge.
If approved on schedule, TAK-003 could mark a major milestone in India’s fight against dengue, bringing much-needed protection to millions living in mosquito-prone areas.
BI Bureau
