India has approved its first dengue vaccine, clearing the way for Japanese pharmaceutical company Takeda's QDENGA to be introduced in one of the world's biggest dengue-endemic countries. The approval comes as India is also moving closer to an indigenous alternative, with Panacea Biotec's DengiAll in the final stage of clinical trials. Once approved, it would become one of the world's first single-dose dengue vaccines.

The Drug Controller General of India (DCGI), under the Central Drugs Standard Control Organisation (CDSCO), has granted market authorisation under the New Drugs and Clinical Trials Rules, 2019, to Takeda Biopharmaceuticals India Pvt Ltd, the Indian arm of Japan's biopharmaceutical major Takeda, for the prevention of dengue in individuals aged four to 60 years.

The approval gives India its first authorised dengue vaccine at a time when the country accounts for nearly one-third of the global dengue burden and continues to battle seasonal outbreaks fuelled by rapid urbanisation, climate change and changing weather patterns.

Vaccine protects against all four dengue virus serotypes

QDENGA is a tetravalent, live-attenuated dengue vaccine designed to provide protection against all four dengue virus serotypes. It can be administered irrespective of previous dengue infection and does not require pre-vaccination screening or testing, making it suitable for use in endemic settings.

The vaccine is administered as a 0.5 ml subcutaneous injection in a two-dose schedule, with the second dose given three months after the first.

The Health Ministry said the vaccine was approved after regulators reviewed its quality, safety and efficacy.

Takeda said the approval in India was based on evidence generated through its global clinical development programme, comprising 19 Phase I, II and III clinical trials involving more than 28,000 participants across dengue-endemic and non-endemic regions.

The programme included the pivotal Phase III TIDES (DEN-301) trial, which enrolled more than 20,000 participants across eight countries to evaluate the vaccine's long-term efficacy and safety.

At 12 months after completion of the two-dose schedule, the vaccine demonstrated an overall efficacy of 80.2% against virologically confirmed dengue.

At 18 months, it showed 90.4% efficacy against dengue-related hospitalisation, achieving a key secondary endpoint. After 4.5 years, the two-dose regimen continued to demonstrate 84.1% efficacy in preventing dengue-related hospital admissions.

The Indian approval is also supported by findings from the Phase III DEN-302 trial conducted among Indian adults, adolescents and children aged four to 60 years. According to the company, the study found the vaccine to be safe, well tolerated and immunogenic.

Takeda added that seven-year follow-up data continue to demonstrate sustained protection against dengue infection and hospitalisation across all four virus serotypes.

WHO-backed vaccine already used in dozens of countries

QDENGA is recommended by the World Health Organization (WHO) for use in dengue-endemic settings and supports introduction into public immunisation programmes in areas with high transmission without the need for pre-vaccination screening.

The vaccine has also received WHO prequalification, confirming that it meets international standards for quality, safety and efficacy. The status also makes it eligible for procurement by international agencies, including UNICEF and the Pan American Health Organization (PAHO), supporting wider global access.

Since its global launch in 2022, QDENGA has been approved in 43 countries across Asia, Europe and Latin America, including the European Union, the United Kingdom, Switzerland and Indonesia. It has been incorporated into Brazil's National Immunisation Programme and is available through public vaccination programmes in Argentina, Colombia and Indonesia.

Takeda said more than 32 million doses have been distributed worldwide through public and private immunisation programmes. The Health Ministry, citing available safety data, said more than 24 million doses have been administered globally without any major safety concerns being reported.

Takeda also has a collaboration with Indian vaccine manufacturer Biological E to expand production of QDENGA.

Dengue continues to pose major public health threat

Dengue remains one of the fastest-growing mosquito-borne viral diseases globally, with cases rising sharply over recent decades.

According to the WHO, the disease is endemic in more than 125 countries, placing nearly half of the world's population at risk. The organisation estimates there are between 100 million and 400 million dengue infections annually.

India carries one of the heaviest burdens globally, accounting for nearly one-third of all dengue cases.

The company said more than 113,000 dengue cases were officially reported in India in 2025. However, modelling studies suggest the actual burden is significantly higher and could amount to tens of millions of infections each year.

According to the Health Ministry, India has recorded more than one million dengue cases and at least 1,500 deaths since 2021.

Takeda said widespread endemicity, rapid urbanisation and climate-related factors that promote mosquito breeding have turned dengue into a year-round public health threat in many parts of India, with seasonal spikes continuing to strain healthcare systems.

The disease has no specific antiviral treatment and can progress rapidly to severe, life-threatening complications requiring hospitalisation and intensive care.

Takeda says approval marks major milestone for India

Mahender Nayak, Head of Intercontinental Markets at Takeda, said the approval represented an important advance in India's dengue prevention efforts.

"Dengue is a growing public health challenge, and India needs sustained, evidence-based prevention. The latest seven-year data for QDENGA show continued protection against dengue infection and hospitalisation across all four serotypes; an important milestone for communities and health systems," he said.

"Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India."

Nayak added that the company, drawing on its 245-year heritage and more than 70 years of vaccine expertise, would continue working with public health authorities, healthcare professionals and partners to support equitable and sustainable access to the vaccine.

Peter Streibl, General Manager for Takeda's Southeast Asia and India Cluster, said dengue required coordinated regional action.

"Dengue is a shared regional challenge that requires collaboration across borders and sectors. Takeda is committed to working with governments, public health authorities, healthcare professionals, and partners across South and Southeast Asia, not only to support access to QDENGA, where approved and recommended, but also to strengthen broader dengue prevention efforts, including surveillance, awareness, vector control, and community engagement. Our aim is to contribute to sustainable, evidence-based solutions that reflect the needs of each country."

Dr Goh Choo Beng, Medical Affairs Head for Takeda's Southeast Asia and India Cluster, said all four dengue virus serotypes are circulating across several parts of India.

"India carries a substantial dengue burden, and all four dengue virus serotypes have been documented as co-circulating in several regions. QDENGA is designed to protect against all four serotypes, regardless of prior exposure. Its approval represents an important step in strengthening India's comprehensive approach to dengue prevention, alongside vector control, surveillance, community awareness and other public health measures."

Homegrown single-dose vaccine also nearing approval

Alongside Takeda's approval, India is also progressing towards an indigenous dengue vaccine.

Panacea Biotec's vaccine candidate, DengiAll, has entered the final stage of clinical trials. If it secures regulatory approval, it would become one of the world's first single-dose dengue vaccines, offering a different vaccination strategy from currently available two-dose vaccines.

Following the DCGI approval, Takeda said it will continue working with Indian regulatory authorities, healthcare providers and public health stakeholders to support the planning, supply and availability of QDENGA across the country.