AIIMS Panel Gives Nod for Covaxin Human Trials

Published: July 19, 2020

The Ethics Committee of the All India Institute of Medical Sciences (AIIMS) has given the approval to start the human trials for the indigenously developed COVID 19 vaccine, Covaxin. The premier hospital is expected to start the trial from July 20 on healthy volunteers.

AIIMS New Delhi is one of the 12 sites designated by the Indian Council of Medical Research to conduct the Phase I and II of human trials of the said vaccine. In the first phase, 375 volunteers will be tested and a maximum of 100 of them would be from AIIMS.

As per the conditions of the trial, healthy volunteers, having no comorbid conditions and without a history of COVID 19, aged between 18-55 years, will be allowed to take part in the said trial. Some volunteers have been identified whereas the rest will be screened from July 20 onwards at the AIIMS. Though the Ethics Committee had raised few concerns, all have been addressed and the trials are now beginning finally.

Background

Covaxin is a COVID 19 vaccine candidate developed by Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology. It has recently received the nod from the Drugs Controller General of India (DCGI). Since this is the first indigenous vaccine developed in India, ICMR has directed to fast-track the trial process as it is also one of the top-priority projects being monitored by the Government of India. The trials have already started in AIIMS, Patna and some more sites in the country.

Along with this, DCGI has also permitted human clinical trials for another vaccine candidate developed by Zydus Cadila Healthcare. Both these have already undergone successful toxicity studies in rats, mice and rabbits. The data was submitted to DCGI and got approved as well.

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