The vaccine has been cleared for use in individuals aged 4 to 60 years and can be administered irrespective of whether the taker has had dengue before, eliminating the need for pre-vaccination screening.
Japan-based Takeda Biopharmaceuticals has received approval from the Drug Controller General of India (DCGI) for its dengue vaccine, QDENGA, making it the first vaccine to be cleared in the country for preventing the disease.
The vaccine has been cleared for use in individuals aged 4 to 60 years and can be administered irrespective of whether the taker has had dengue before, eliminating the need for pre-vaccination screening.
Until now, dengue prevention has relied largely on mosquito control, surveillance and public awareness, while treatment has been limited to supportive care because there is no specific antiviral therapy for the disease.
Key Points
- DCGI has approved Takeda's QDENGA, making it the first dengue vaccine authorised in India for people aged 4 to 60 years.
- The two-dose vaccine protects against all four dengue virus serotypes and does not require pre-vaccination screening before administration.
- Global and Indian clinical studies showed strong efficacy against confirmed dengue infections and significant protection against dengue-related hospitalisation.
- WHO recommends QDENGA for dengue-endemic regions, and the vaccine has already received approvals across 43 countries worldwide.
- Takeda plans a private-market launch in India next year, while pricing and commercial availability are yet to be announced.
India's Dengue Burden
The clearance comes at a time when India continues to face a growing dengue burden.
Reported cases have increased more than 11 times over the past two decades.
More than 113,000 instances were reported last year.
However, modelling studies suggest the number could run into tens of millions annually.
QDENGA is a live-attenuated tetravalent vaccine designed to give protection against all four dengue virus serotypes.
It is administered as a two-dose regimen, with the second dose given three months after the first.
QDENGA Clinical Trial Results
The approval is based on Takeda's global clinical development programme, involving more than 28,000 participants across 19 Phase I, II and III clinical trials, as well as a Phase III study conducted in India.
According to the company, its pivotal Phase III TIDES trial, which enrolled over 20,000 participants, demonstrated an efficacy of 80.2 per cent against virologically confirmed dengue one year after the second dose.
The study also reported 90.4 per cent efficacy against dengue-related hospitalisation after 18 months and 84.1 per cent efficacy in preventing hospitalisation over four and a half years.
'Dengue is a growing public health challenge, and India needs sustained, evidence-based prevention,' the company said.
WHO Backs Dengue Vaccine
The World Health Organization (WHO) recommends QDENGA for use in dengue-endemic settings without requiring pre-vaccination screening.
The vaccine has also received WHO prequalification, making it eligible for procurement by international agencies such as Unicef.
Since its first approval in 2022, QDENGA has secured regulatory approval in 43 countries in Asia, Latin America and Europe.
More than 32 million doses have been distributed globally through public and private immunisation programmes.
The vaccine is part of Brazil's National Immunisation Programme and is also available through public vaccination programmes in Argentina, Colombia and Indonesia.
India Launch Plans
Takeda expects QDENGA to become commercially available in India during the first half of next year subject to regulatory and supply chain processes being completed.
The company said the vaccine would be manufactured at Takeda's facility in Singen, Germany, after which each batch would undergo a mandatory quality review by the Central Drugs Laboratory before commercial distribution.
The company also said it would ensure adequate manufacturing capacity to meet demand from India.
Takeda has not finalised the pricing for India.
'We are committed to supporting broad, equitable, timely and sustainable access at a cost that reflects the vaccine's value and potential health, societal and economic benefits.
'Pricing and availability will be communicated once local processes are complete,' it said.
The vaccine is expected to be launched through private health care units.
"The approval marks a genuine shift in how we approach dengue in India. Until now, management has been limited to vector control and supportive care because we have no specific antiviral therapy," said Dr Suresh F Shah, founder and lead pediatrician, Sparsh Children's Hospital.
The vaccine's ability to generate immunity against all four dengue virus serotypes was particularly important for India, where multiple serotypes circulated simultaneously and secondary infections were often associated with severe disease, Dr Shah added.
However, he said while the vaccine had shown strong efficacy, protection was not absolute and long-term durability was still being studied.
"Vaccination must remain one layer within integrated prevention. It does not replace source reduction, personal protection, and early recognition of warning signs such as persistent vomiting, abdominal pain or mucosal bleeding."
Feature Presentation: Ashish Narsale/Rediff
