Qdenga Dengue Vaccine Is Coming To India: Here Is What To Expect

Takeda’s dengue vaccine Qdenga is set to launch in India in partnership with Biological E. The vaccine targets all 4 dengue strains, and efforts are being made to ensure affordability.

Takeda's Qdenga vaccine is currently undergoing local trials in India.

Source : Canva (modified)

Japanese drugmaker Takeda is gearing up to launch its tetravalent dengue vaccine, Qdenga, in India. The vaccine will be brought to India in partnership with Hyderabad-based Biological E. The vaccine will be available for both children and adults, aligning with World Health Organization's recommendations and India’s public health goals.

The vaccine, already approved in over 40 countries, will undergo final regulatory review in India. A full launch is expected in 2026, according to Takeda's global vaccine head, Derek Wallace, as reported by The Times of India. 

Takeda is actively communicating with multiple media platforms to provide updates on Qdenga's anticipated launch in India.

"We’ve recognised dengue as a global health challenge. India is a high-priority market, and we are committed to ensuring broad access through local partnerships and a tiered pricing model,” Wallace was quoted as saying.

What Is Qdenga?

Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) is Takeda’s first globally marketed vaccine. It protects against all four dengue virus serotypes (DEN-1 to DEN-4) and is administered in two doses, three months apart. Unlike the earlier vaccine Dengvaxia, which was limited to individuals with previous dengue infections, Qdenga is safe for people regardless of prior exposure.

The vaccine has already sold over 10 million doses since its global launch in 2023. Clinical trials, including the landmark TIDES study involving 20,000 children across eight countries, demonstrated significant protection against hospitalisation and severe dengue.

#BiologicalELimited #BioE #BE #Takeda #DengueVaccine #QDENGA #MultiDoseVials #DengueTetravalentVaccine #TAK003 #MDVs #DengueFever #Denguehttps://t.co/tCkQzOgep4 pic.twitter.com/xoPAVZnALV

— Biological E. Limited (@biological_e) February 27, 2024

A Made-In-India Vaccine

To align with India’s Make-in-India initiative, Takeda has tied up with Biological E to manufacture Qdenga locally. This includes setting up production for both single- and multi-dose vials. Multi-dose vials are especially useful in public immunisation drives due to their cost efficiency and easier storage.

"Our goal is to manufacture 100% of the doses in India over time, with Bio E contributing half of our global production target of 100 million doses annually by the end of the decade,” Wallace told ToI.

Currently, Takeda’s German facility handles single-dose production. With Bio E as the sole manufacturer of multi-dose vials, India will also become a global supply hub.

Who Can Get the Vaccine? Pricing And Access

Qdenga will be introduced in India’s private sector for both children and adults, while public rollout under the National Immunisation Programme will initially focus on children, in line with WHO’s guidance for high-burden countries.

Currently, the vaccine is available in the private market in Indonesia, Thailand, and countries in Europe. Children and adults in Argentina and Brazil also have access to the vaccone in the private sector and through some public programmes.

The vaccine is approved for individuals aged 6 years and above. However, it is not recommended for pregnant or breastfeeding women or those with compromised immune systems. Common side-effects are claimed to be mild and include pain at the injection site, headache, and fever.

Takeda plans to implement a tiered pricing strategy, negotiating lower prices for government procurement to ensure affordability in low-income regions

According to Wallace, they would be looking at public-private partnerships "to make this vaccine widely accessible". Talks with Indian authorities are underway to build trust, share safety data, and plan a national rollout roadmap.

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Why India Needs Dengue Vaccine Qdenga

India reports nearly 3 lakh dengue cases annually, with rising numbers attributed to climate change, urbanisation, and globalisation. With half the world’s population at risk, experts believe that vaccines like Qdenga are a critical addition to vector control measures like fogging and mosquito nets.

"Vaccines can reduce severe disease and hospital burden, but community awareness and mosquito control remain key,” said Dr. Anupama Rawat, a tropical medicine expert.

Speaking to Business Standard about the regulatory process and clinical trials, Dion Warren, head of Takeda’s India and Southeast Asia Multi-Country Organization, had last year highlighted the high disease burden in India and other countries in Asia as he emphasised the sense of urgency given to the local clinical trials.

With the local trials of the Qdenga vaccine under way in India to generate additional safety and efficacy data, regulatory approvals are expected by late 2025, and market launch is likely in early 2026.

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