Dengue Vaccine in India: Approval, Eligibility, Safety & Effectiveness  

Introduction

Dengue is a major mosquito-borne disease in India, with seasonal outbreaks placing a significant burden on public health¹. as cases continue to rise, there is growing interest in effective preventive measures, including vaccination. However, developing a dengue vaccine has been challenging because the disease is caused by four different dengue virus serotypes, all of which need to be addressed for effective protection^1,2.  

In recent years, important progress has been made in dengue vaccine development. This blog explores the current status of dengue vaccines in India, including their approval, eligibility, safety, and effectiveness. 

Is There a Vaccine for Dengue?

Vaccines for dengue have been developed, and some are approved for use in several countries. However, unlike many routine vaccines, dengue vaccines are not universally recommended because their safety and effectiveness can depend on factors such as a person’s age and whether they have had a previous dengue infection. As a result, countries adopt different vaccination policies based on local disease patterns and available evidence^3,4. 

Developing a dengue vaccine has been particularly challenging because dengue is caused by four different virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4). Infection with one serotype provides long-term protection only against that specific type, while a later infection with another serotype may increase the risk of severe dengue through a process called antibody-dependent enhancement (ADE). Therefore, an effective vaccine must provide balanced protection against all four serotypes without increasing the risk of severe disease^5,6. 

Despite these challenges, global research has made significant progress.  

• Dengvaxia® (CYD-TDV) was the first dengue vaccine to receive approval and is recommended only for individuals with confirmed previous dengue infection^3,7.  
• Qdenga® (TAK-003) has since been approved in several countries and offers broader protection in eligible populations, although recommendations vary by region⁷.  
• In addition, several other vaccine candidates, including those from the U.S. National Institutes of Health (TV003/TV005), the Butantan Institute in Brazil, and some Indian manufacturers, are in advanced stages of clinical development. These ongoing efforts are expected to expand safe and effective vaccination options, particularly for countries like India where dengue remains a major public health concern⁷.

Dengue Vaccine Approved in India

If you are looking for the name of the dengue vaccine approved in India , it is Qdenga, the first dengue vaccine approved in India⁸.  

Qdenga is a live, weakened vaccine that helps protect against all four types of the dengue virus. It was developed using recombinant DNA technology, a method that allows scientists to safely modify the virus so it can stimulate the immune system without causing dengue in healthy individuals. The vaccine is manufactured using Vero cells, supplied as a freeze-dried powder, and is mixed with a liquid before being given as an injection under the skin (subcutaneous injection)⁸. 

The main features of this dengue fever vaccine in India are outlined in the table below⁸. 

Note: Although Qdenga has received regulatory approval, dengue vaccination is not yet part of India’s Universal Immunisation Programme (UIP). The vaccine is expected to be available initially through the private healthcare sector.  

How Does the Dengue Vaccine Work?

Qdenga is a live attenuated tetravalent vaccine. This means that it contains weakened versions of all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4)⁹. 

This dengue fever vaccine helps the immune system build protection against dengue without causing the disease. It works through the following steps^9,11: 

• Step 1: The vaccine is administered as two doses given three months apart to complete the vaccination schedule. 
• Step 2: The weakened dengue viruses enter the body and safely mimic a natural infection without causing dengue in healthy individuals. 
• Step 3: The immune system recognises the weakened viruses as foreign and activates immune cells to respond. 
• Step 4: The body produces neutralising antibodies against all four dengue virus serotypes, preparing the immune system to recognise the virus if exposed in the future. 
• Step 5: Immune memory develops, with memory cells remaining in the body. These cells enable a faster and stronger immune response during future dengue infections. 
• Step 6: If the vaccinated person is later infected through the bite of an infected mosquito, the immune system quickly recognises the dengue virus and mounts a rapid immune response, reducing the risk of symptomatic disease, severe dengue, and hospitalisation. 
• Step 7: Long-term protection is expected after completing both doses, making it important to receive the full vaccination course as recommended. 

Who Is Eligible for the Dengue Vaccine?

According to the World Health Organization (WHO), Qdenga is recommended primarily for use in areas where dengue transmission is high, and the disease poses a significant public health burden. Eligibility is based on factors such as age, local dengue transmission, and certain medical conditions. 

Who Can Receive the Dengue Vaccine?

The following individuals may be eligible for Qdenga⁸: 

• People aged 4 to 60 years  
• Individuals living in areas where dengue is endemic or where dengue is a significant public health concern.  

Who Should Not Receive the Dengue Vaccine?

Qdenga should not be administered to⁹: 

• Children younger than 4 years. 
• Pregnant women or those planning to become pregnant within one month after vaccination. 
• Women who are breastfeeding. 
• People with congenital or acquired immunodeficiency, including those receiving immunosuppressive therapies such as chemotherapy or high-dose systemic corticosteroids. 
• People with symptomatic HIV infection or asymptomatic HIV infection with impaired immune function. 
• Individuals with a history of severe allergic reactions to any component of the vaccine or following a previous dose. 

Dengue Vaccine Dosage Schedule

The Qdenga dengue fever vaccine is administered as a two-dose primary vaccination series. Completing both doses is essential to achieve the recommended level of protection against dengue. Here is what to expect^8,9: 

Note: According to the WHO, the interval between doses should not be shortened, and if the second dose is delayed, the vaccination series does not need to be restarted⁹. 

How Effective Is the Dengue Vaccine?

Qdenga vaccine provides protection against dengue. Its approval is based on a large global clinical development programme that evaluated the vaccine’s safety, immunogenicity (ability to trigger an immune response), and efficacy. Key evidence supporting the effectiveness of Qdenga includes⁸: 

• Backed by large-scale clinical research: Qdenga has been evaluated through a comprehensive global clinical development programme involving participants from multiple dengue-endemic and non-endemic countries, including Brazil, Thailand, and Sri Lanka. 
• Studied in the Indian population: Before receiving approval in India, the vaccine underwent a Phase III clinical trial involving individuals 4 to 60 years of age. It was observed that the vaccine produced a robust immune response while maintaining an acceptable safety profile in Indian participants. 
• Designed to provide broad protection: Qdenga is a live attenuated tetravalent vaccine developed using recombinant DNA technology. It is formulated to generate immunity against all four dengue virus serotypes, helping reduce the risk of symptomatic dengue and severe disease.  
• Authorised by regulatory authorities worldwide: The vaccine has been authorised for use in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia, and Thailand, following review of its clinical efficacy and safety data. 
• Meets international quality standards: Qdenga has received WHO prequalification, indicating that it satisfies internationally accepted standards for vaccine quality, safety, and performance. 

Is the Dengue Vaccine Safe?

More than 24 million doses of Qdenga have been administered globally. Ongoing post-marketing monitoring has continued to show a favourable safety profile, with no new major safety concerns reported⁸. overall , most people tolerate Qdenga well. If side effects occur, they are usually mild to moderate, begin within 1 to 2 days after vaccination, and resolve within 1 to 3 days. Common side effects include¹²: 

• Pain, redness, swelling, bruising, or itching at the injection site 
• Headache 
• Muscle pain 
• Joint pain 
• Fever 
• Tiredness, weakness, or feeling unwell 
• Mild flu-like symptoms 
• Reduced appetite (mainly in young children) 

Other less common side effects include¹²: 

• Nausea or vomiting 
• Diarrhoea 
• Stomach pain 
• Dizziness 
• Rash, itching, or hives 
• Common cold or sore throat 

Important: Most side effects after Qdenga are mild and resolve within a few days. However, seek immediate medical attention if you experience symptoms of a severe allergic reaction, such as difficulty breathing, swelling of the face, lips, tongue, or throat, severe rash or hives, dizziness, or fainting¹². Although these reactions are very rare, prompt treatment is essential. 

Other Ways to Prevent Dengue

Although vaccination can help reduce the risk of dengue in eligible individuals, preventing mosquito bites remains the most effective way to avoid infection. Follow these simple preventive measures¹³: 

• Apply an insect repellent on exposed skin, especially during the day when dengue mosquitoes are most active. 
• Wear loose-fitting, full-sleeved clothing and long pants to reduce exposed skin. 
• Eliminate stagnant water in and around your home, such as in buckets, flowerpots, coolers, and discarded containers, to prevent mosquito breeding. 
• Keep doors and windows screened or stay in air-conditioned rooms whenever possible. 
• Sleep under a mosquito net if screened or air-conditioned rooms are not available, especially when sleeping during the day. 
• Take extra precautions while travelling to dengue-prone areas by carrying insect repellent and following local health advisories. 
• Seek medical attention promptly if you develop fever or symptoms suggestive of dengue, particularly during or after visiting an area where dengue is common. 
• Continue protecting yourself from mosquito bites for up to 3 weeks after returning from a dengue-endemic area, even if you feel well, to help prevent further spread of the virus. 

Also Read: Natural Home Remedies for Dengue 

Conclusion

The approval of Qdenga marks an important step forward in India’s efforts to reduce the burden of dengue. While the vaccine offers protection against dengue, particularly against severe disease and hospitalisation in eligible individuals, it is not a substitute for mosquito control and bite prevention. 

Following the recommended vaccination schedule, staying informed about eligibility, and continuing preventive measures such as using insect repellents and eliminating mosquito breeding sites remain essential. Together, vaccination and mosquito control provide the best strategy for reducing the impact of dengue in India. 

Frequently Asked Questions (FAQs)

References

1. Pescador Ruschel MA, Panda PK, Farmer A. Dengue fever. StatPearls. Accessed July 23, 2026.2026. https://www.ncbi.nlm.nih.gov/books/NBK430732/  

2. Mutheneni SR, Morse AP, Caminade C, Upadhyayula SM. Dengue burden in India: recent trends and importance of climatic parameters. Emerg Microbes Infect. 2017;6(8):e70. doi:10.1038/emi.2017.57. https://pubmed.ncbi.nlm.nih.gov/28790459/  

3. About a Dengue Vaccine. CDC. May 15, 2025. Accessed July 23, 2026. https://www.cdc.gov/dengue/vaccine/index.html  

4. Kant R, Singh A, Ali AB, Nagre S, Ganguly NK, Rana R. Dengue vaccine effectiveness and safety: a systematic analysis of recent clinical trial data. Virol J. 2025;22:384. doi:10.1186/s12985-025-02937-x. https://pubmed.ncbi.nlm.nih.gov/41287091/  

5. Anumanthan G, Sahay B, Mergia A. Current Dengue Virus Vaccine Developments and Future Directions. Viruses. 2025;17(2):212. doi:10.3390/v17020212. https://pubmed.ncbi.nlm.nih.gov/40006967/  

6. Aynekulu Mersha DG, van der Sterren I, van Leeuwen LPM, et al. The role of antibody-dependent enhancement in dengue vaccination. Trop Dis Travel Med Vaccines. 2024;10:22. doi:10.1186/s40794-024-00231-2. https://pubmed.ncbi.nlm.nih.gov/39482727/  

7. Lee MF, Long CM, Poh CL. Current status of the development of dengue vaccines. Vaccine X. 2025;22:100604. doi:10.1016/j.jvacx.2024.100604. https://pubmed.ncbi.nlm.nih.gov/39830640/  

8. CDSCO Approves India’s First Dengue Vaccine, Strengthening National Dengue Prevention Efforts. Ministry of Health and Family Welfare. Accessed July 23, 2026. https://www.pib.gov.in/www.pib.gov.in/Pressreleaseshare.aspx?PRID=2286883   

9. Vaccines and immunization: Dengue. CDC. Accessed July 23, 2026. https://www.who.int/news-room/questions-and-answers/item/dengue-vaccines  

10. How do vaccines work? World Health Organization. Accessed July 23, 2026. https://www.who.int/news-room/feature-stories/detail/how-do-vaccines-work  

11. Explaining How Vaccines Work. CDC. May 7, 2026. Accessed July 23, 2026. https://www.cdc.gov/vaccines/basics/explaining-how-vaccines-work.html  

12. Qdenga, INN-Dengue tetravalent vaccine (live, attenuated). European Medicines Agency. Accessed July 23, 2026. https://www.ema.europa.eu/en/documents/product-information/qdenga-epar-product-information_en.pdf   

13. Preventing Dengue. CDC. May 29, 2025. Accessed July 23, 2026. https://www.cdc.gov/dengue/prevention/index.html  

14. Takeda. Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy Children Aged 4 – 16 Years Old. Clinicaltrials.gov; 2025. Accessed July 23, 2026. https://clinicaltrials.gov/study/NCT02747927   

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