COVAXIN Human Trials: Bharat Biotech and the Indian Council of Medical Research (ICMR) have jointly begun the human trials of India's indigenous COVID-19 vaccine named COVAXIN. The vaccine has entered into Phase 1 of human trials at various medical institutions including AIIMS Delhi, Goa's Redkar Hospital, PGIMS Rohtak, AIIMS Patna and others. Know here how will the trials of Coronavirus vaccine take place and when will it be ready. Also, get to know when will Covaxin be available for public use and at what Price.
The Covaxin has been developed by Bharat Biotech in collaboration with the National Institute of Virology, Pune under ICMR. Both the firms together are conducting the human trials now after receiving the approvals from the Drugs Controller General of India (DCGI).
Have a look at the given questions below that answer everything you need to know about India's own Coronavirus vaccine:
What is COVAXIN?
COVAXIN is a vaccine developed by ICMR & Bharat Biotech for the treatment of novel Coronavirus. The vaccine has been developed indigenously in India at the Bio-Safety Level 3 (BSL-3) high containment facility of Bharat Biotech. The vaccine is also known as BBV152 COVID Vaccine. This inactivated vaccine has been made from the treated novel coronavirus particles.
When will human trials of COVAXIN begin?
The Covaxin has received the DCGI approval to undergo the Phase I & Phase II of Clinical Trials that will be conducted on humans. The Phase I of trials have begun in July 2020.
Who can take part in COVAXIN human trials?
Healthy volunteers who have no co-morbid conditions or history of COVID-19 are eligbile to take part in human trials of Covaxin. The volunteers should be of minimum 18 years of age and maximum 55 years.
Where are human trials of Covaxin being conducted?
The human trials of Covaxin are being conducted at 12 sites selected by the ICMR itself. Some of these sites are:
- All India Institute of Medical Sciences (AIIMS), New Delhi
- AIIMS Patna
- Redkar Hospital, Goa
- PGIMS Rohtak
- Institute of Medical Sciences and SUM (IMS & SUM) Hospital, Bhubaneswar
How will Covaxin human trials take place?
AIIMS Delhi will begin the human trials of indigenous Covaxin by first screening the volunteers. And the similar process will be followed at other sites. In Phase I & II of human trials, volunteers will be divided into 4 groups. Of these 4 groups, three will receive the Covaxin formulations and the last group will be "Control Group" that will receive Japanese encephalitis vaccine, developed by Bharat Biotech.
The control group will help the researchers in knowing the impact of Covaxin on people. However, volunteers will not be able to know the vaccine they are being given - Covaxin or Japanese encephalitis.
Phase-wise details of trials:
In phase I, professionals will check whether the vaccine is safe for humans.
Once the Phase I of trials gets completed, the vaccine will move to Phase II of trials where the researchers will check whether the vaccine is successful enough to generate the required immune response to fight the Coronavirus.
In phase III of human trials, the researchers will test all the aspects of Covaxin including its safety, ability to induce response from immune system and others.
How many people will participate in Covaxin human trials?
In Phase 1 of the human trials, 375 volunteers of 18-55 years age will be administered with a dose of the experimental vaccine across the country. In phase II trials, 750 people of 12-65 years age will be participating across the country.
When will Covaxin be ready & available for public use?
Bharat Biotech has stated that the phase 1 and 2 trials will likely take 1 year and 3 months to complete. If this is taken into account, it is expected that the Covaxin might be available for public in next two years.
The clinical trials of a safe vaccine takes months and years. As per previous records, fastest developed vaccine took 4 years.
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