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India's first Dengue vaccine to be rolled out soon: Phase 3 trial enrollment nears completion

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Dengue fever is a mosquito-borne viral infection, primarily spread by the Aedes aegypti mosquito, which is active during the day. It can cause a range of symptoms, from mild to severe, and in some cases, can be fatal, especially those with compromised immunity. India, in particular, accounts for the world's 100–400 million infections. Every year during the monsoons the infection reaches a peak, but now there is some hope. India’s first dengue vaccine is now in the final stages of testing, with phase 3 trial enrolment almost complete. Let's find out more...

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Why is dengue dangerous

Dengue is a viral infection spread by Aedes mosquitoes. It causes high fever, severe headaches, joint and muscle pain, and sometimes a dangerous drop in blood platelets. In severe cases, dengue can lead to bleeding, organ failure, and even death. Children and the elderly are most at risk.


Challenges in making a vaccine
For years now, scientists have tried to develop a safe and effective dengue vaccine. The challenge however, is that there are four different types of dengue viruses, and a common vaccine must protect against all of them. Some vaccines developed in other countries have shown mixed results, but are not widely used.

India's home grown vaccine
India’s first dengue vaccine is being developed by Serum Institute of India (SII). The vaccine, called “TetraVax-DV,” is designed to protect against all four types of dengue viruses. Like other vaccines, it uses a weakened form of the virus to train the body’s immune system to fight dengue. Since it is not a live virus per se, it does not cause the ailment itself.

Key features of the vaccine
Targets all four dengue virus types
Developed using advanced technology
Tested for safety and effectiveness

What are Phase 3 Trials?

Before a vaccine can be approved for public use, it must go through several stages of testing:
Phase 1: Small group of healthy volunteers to test safety
Phase 2: Larger group to test immune response and side effects
Phase 3: Thousands of volunteers to test how well the vaccine works in a larger group
Hence, Phase 3 is the most important stage. It shows if the vaccine can actually prevent dengue in the community as a whole.

Where does India stand
The phase 3 trial for India’s dengue vaccine began in 2023. It is being conducted at more than 20 sites across the country, including both urban and rural areas. The trial aims to enrol over 10,000 volunteers, including children and adults from different backgrounds. As of now, enrollment is almost complete, and early results show good results.

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Next steps
Monitoring: Volunteers will be monitored for any side effects and for protection against dengue.
Data Analysis: Scientists will study the data to see how well the vaccine works.
Approval: If the results are good, the vaccine could be approved by Indian health authorities within a year.

Why is the vaccine important
India has one of the highest dengue cases in the world. Early outbreaks put pressure on hospitals and cause suffering for families. A safe and effective vaccine could:


Reduce the number of dengue cases
Lower hospital admissions
Save lives, especially among children
Reduce the economic burden on families and the healthcare system

Regardless of the vaccine, one must practice prevention against dengue during this season, that includes protection against mosquitoes, (lotions, full clothes etc) covering all drains, and not allowing breeding of eggs in any open water source.

Source
The Indian Council of Medical Research (ICMR) and Panacea Biotec
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