India has approved the Qdenga dengue vaccine, making it the country’s first approved dengue vaccine. The Drug Controller General of India (DCGI) granted approval to Takeda Biopharmaceuticals India’s vaccine, which is designed to protect against all four dengue virus strains. The approval comes at a time when dengue cases are rising steadily across the country, making the Qdenga dengue vaccine a significant public health milestone.
What is the Qdenga dengue vaccine?
The Qdenga dengue vaccine is designed to provide protection against all four dengue virus serotypes—DENV-1, DENV-2, DENV-3 and DENV-4. It has been approved for people aged between four and 60 years, regardless of whether they have previously had dengue.
One of its key advantages is that it does not require pre-vaccination screening. The vaccine is administered through two subcutaneous doses of 0.5 mL each, with the second dose given three months after the first.
What did the clinical trials find?
The approval is based on Takeda’s global clinical development programme, which included 19 Phase 1, 2 and 3 clinical trials involving more than 28,000 participants across dengue-endemic and non-endemic regions.
Its Phase III TIDES (DEN-301) trial studied over 20,000 participants in eight countries and assessed the vaccine’s long-term safety and effectiveness. The findings showed that the Qdenga dengue vaccine achieved an overall efficacy of 80.2% against virologically confirmed dengue 12 months after the second dose. The study also found that it offered sustained protection against dengue-related hospitalisation.
When will it be available?
Takeda has partnered with Hyderabad-based Biological E to manufacture up to 50 million doses annually in India. While the company has not yet announced the vaccine’s price, local production is expected to make it more affordable. The final cost may also depend on whether the vaccine is included in future government immunisation programmes.
India accounts for nearly one-third of the global dengue burden, with reported cases increasing significantly over the past two decades. Health experts believe the Qdenga dengue vaccine could play an important role in reducing severe infections and dengue-related hospitalisations.
FAQs
Q: What is the Qdenga dengue vaccine?
A: The Qdenga dengue vaccine is India’s first approved dengue vaccine and protects against all four dengue virus strains.
Q: Who can receive the Qdenga dengue vaccine?
A: It is approved for individuals aged 4 to 60 years, regardless of previous dengue infection, without requiring pre-vaccination testing.
Q: How many doses are required?
A: The vaccine is given in two doses of 0.5 mL each, administered three months apart.
Q: How effective is the vaccine?
A: Clinical trials showed the vaccine had an overall efficacy of 80.2% against virologically confirmed dengue one year after the second dose.
