India's 1st ever dengue vaccine has come from Japan
What's the story
Takeda Pharmaceutical's dengue vaccine, QDENGA, has been approved by India's drug regulator. This marks a historic milestone as QDENGA becomes the first-ever dengue vaccine to get the green light in India. The live-attenuated tetravalent vaccine protects against all four serotypes of the dengue virus and can be given regardless of prior exposure to dengue or pre-vaccination screening.
Partnership
Takeda partners with Indian manufacturer Biological E
The approval of QDENGA comes at a crucial time for public health, with reported dengue cases in India increasing 11-fold over the last two decades.
Takeda has partnered with Indian vaccine manufacturer Biological E to scale up production of QDENGA.
The collaboration aims to ramp up production capacity to 50 million doses annually and support Takeda's global goal of producing 100 million doses per year by the end of the decade.
Vaccination reach
QDENGA approved in 43 countries
Since its launch in 2022, QDENGA has been approved in 43 countries and over 32 million doses have been distributed worldwide.
The vaccine is recommended by the World Health Organization (WHO) for use in dengue-endemic areas and supports its introduction into public immunization programs without pre-vaccination screening.
It has also received WHO prequalification, confirming it meets global standards for quality, safety, and efficacy.
Trial results
Clinical trial data from over 28,000 participants
The approval in India is based on data from Takeda's global clinical development program, including 19 Phase 1, 2, and 3 clinical trials with over 28,000 participants.
A Phase III clinical trial (DEN-302) conducted in Indian participants evaluated the safety and immunogenicity of the vaccine.
QDENGA is administered subcutaneously as a two-dose regimen with doses given three months apart.