India Prepares for the Launch of Qdenga: A Game-Changer in Dengue Prevention

Introduction

India has long struggled with the burden of dengue fever, a mosquito-borne viral disease that affects millions annually. With nearly 300,000 cases reported last year, the country has been searching for an effective solution to curb the spread of the disease. Now, Japanese pharmaceutical giant Takeda is set to introduce its tetravalent dengue vaccine, Qdenga, in India next year, in collaboration with Hyderabad-based Biological E (Bio E). This development marks a significant milestone in India’s fight against dengue.

Qdenga: India's Dengue Vaccine — Qdenga: India’s Dengue Vaccine

What is Qdenga?

Qdenga, also known as TAK-003, is a live-attenuated tetravalent vaccine designed to protect against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4). Unlike previous dengue vaccines, Qdenga is safe for individuals regardless of prior dengue exposure, making it a more accessible option for populations in endemic regions. The vaccine is administered in two doses, spaced three months apart, and has demonstrated long-term protection for up to 4.5 years.

Why is Qdenga Important for India?

India has witnessed an eightfold increase in dengue cases over the past two decades, largely due to climate change, urbanization, and globalization. The introduction of Qdenga is expected to significantly reduce hospitalizations and severe dengue cases, particularly among children and vulnerable populations. The vaccine has already been approved in over 40 countries, including Indonesia, Thailand, Argentina, Brazil, and the European Union, and has sold over 10 million doses globally since its launch in 2023.

Takeda’s Partnership with Biological E

To align with India’s Make-in-India initiative, Takeda has partnered with Biological E to manufacture Qdenga locally. This collaboration will ensure affordable pricing and widespread availability of the vaccine. Biological E will be responsible for producing both single-dose and multi-dose vials, which are particularly useful for public immunization programs. Takeda aims to manufacture 100% of the doses in India over time, with Bio E contributing half of the global production target of 100 million doses annually.

TIDES Phase 3 Clinical Trial

The TIDES (TAK-003 Efficacy Study) was a landmark Phase 3 trial that evaluated Qdenga’s efficacy, safety, and immunogenicity. The study included over 20,000 children and adolescents across eight dengue-endemic countries.

Key Findings:

Overall vaccine efficacy (VE): 80.2% against virologically confirmed dengue (VCD).
Hospitalization prevention: 84.1% efficacy in preventing hospitalized dengue cases.
Long-term protection: 61.2% efficacy over 54 months.
Serotype-specific efficacy:
- DENV-1: 69.8% efficacy.
- DENV-2: 95.1% efficacy (highest protection).
- DENV-3: 48.9% efficacy.
- DENV-4: Data suggests lower efficacy, requiring further research.

WHO Prequalification & Global Approval

Qdenga received WHO prequalification in May 2024, making it eligible for global procurement programs.
The vaccine has been approved in over 40 countries, including Indonesia, Thailand, Brazil, Argentina, and the European Union.

Safety Profile

Mild to moderate side effects include fever, headache, fatigue, and injection-site pain.
Unlike previous dengue vaccines, Qdenga is safe for individuals regardless of prior dengue exposure.
WHO recommends Qdenga for children aged 6 to 16 years in high-transmission areas.

Regulatory Approval and Rollout Plans

While Qdenga has received prequalification from the World Health Organization (WHO), it is currently undergoing final regulatory review in India. Takeda has submitted a comprehensive data package to Indian authorities, and the vaccine is expected to be licensed by 2026. The rollout will take place in both private and public sectors, with an initial focus on pediatric immunization under India’s National Immunization Program. However, the vaccine will also be available for adults in the private sector, ensuring broader access.

How Does Qdenga Work?

Qdenga is a live-attenuated vaccine, meaning it contains weakened forms of the dengue virus that stimulate the immune system without causing disease. This approach mimics a natural infection, allowing the body to develop strong and lasting immunity against all four dengue strains. Clinical trials, including the landmark TIDES study involving 20,000 children across eight countries, have demonstrated significant protection against hospitalization and severe dengue.

Who Can Receive the Vaccine?

According to WHO guidelines, Qdenga is recommended for children aged 6 to 16 years in areas with high dengue transmission. It is not currently recommended for children under 6 years due to lower efficacy observed in this group. Additionally, individuals with comorbidities residing in dengue-endemic regions may be considered for vaccination, provided there is documented evidence of a significant burden of severe dengue outcomes.

Challenges and Future Prospects

Despite the promising outlook, the successful implementation of Qdenga in India will depend on public awareness, government support, and affordability. Takeda has emphasized the importance of public-private partnerships to ensure broad vaccine accessibility. The company is actively engaging with Indian health authorities to build trust and establish a national rollout roadmap.

Conclusion

The launch of Qdenga in India represents a major breakthrough in dengue prevention. With local manufacturing, tiered pricing models, and strategic partnerships, Takeda and Biological E are poised to make the vaccine widely accessible. As India prepares for the rollout, Qdenga has the potential to save thousands of lives and significantly reduce the burden of dengue in the country.

Frequently asked questions

1. What is Qdenga and how does it work?

Qdenga is a live-attenuated tetravalent dengue vaccine developed by Takeda Pharmaceuticals. It is designed to protect against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4). The vaccine contains a weakened form of the dengue virus, which helps the immune system build long-term protection without causing illness. It is administered in two doses, three months apart, and has shown up to 4.5 years of protection in clinical trials.

2. When will Qdenga be available in India, and who can receive it?

Takeda, in partnership with Biological E, plans to launch Qdenga in India by 2026, pending final regulatory approval. The vaccine will be available through both private and public healthcare sectors. Initially, it will target children aged 6 to 16 years, as recommended by the World Health Organization (WHO). However, adults in dengue-endemic areas may also have access through private healthcare providers.

3. How effective is Qdenga in preventing dengue?

Qdenga has undergone extensive clinical trials, including the TIDES study, which involved 20,000 children across eight countries. The results showed that Qdenga reduces hospitalization and severe dengue cases by over 80%. Unlike older dengue vaccines, Qdenga is safe for people regardless of prior dengue exposure, making it a viable option for broad immunization efforts.

4. What are the side effects of Qdenga?

Clinical trials have indicated that Qdenga is generally well-tolerated, with mild to moderate side effects such as fever, headache, fatigue, and injection-site pain. These symptoms typically resolve within a few days. The vaccine has not shown significant risks of antibody-dependent enhancement (ADE), a concern with previous dengue vaccines.

5. Why is Qdenga significant for India’s fight against dengue?

India has seen a sharp rise in dengue cases, with nearly 300,000 cases reported last year. Factors like climate change, urbanization, and increased mosquito populations have worsened the situation. Qdenga’s arrival marks a major step in dengue prevention, potentially reducing the burden on hospitals, saving lives, and preventing severe outbreaks. With local manufacturing by Biological E, the vaccine is expected to be affordable and widely accessible.