Bharat Biotech has announced commencement of Phase III trials of India’s indigenous COVAXIN vaccine on November 16, 2020.
The Phase III trials of COVAXIN would involve 26,000 volunteers from all across India. Phase III trials would be conducted in partnership with Indian Council of medical Research (ICMR).The third phase is the largest clinical trial being conducted for a COVID-19 vaccine in India. Volunteers who wants to participate in the third phase of the trial should be over 18 years of age.
This trial is India’s first phase 3 efficacy study for a COVID-19 vaccine. It is also the largest phase III efficacy trial ever conducted in India. The trial has been registered at the website of ICMR called clinical trial registry-India. The trial was approved by the Drugs Controller General of India (DGCI).
Volunteers selected for trail would receive two intramuscular injections with a gap of 28 days. They will be assigned randomly to receive COVAXIN or placebo. The third phase trial is double blinded. Thus, the investigators, the participants and the company would not be aware of who is assigned to which group.
COVAXIN is India’s indigenous COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research – National Institute of Virology. It has been developed and manufactured in Bharat Biotech’s BSL-3 bio-containment facility. COVAXIN has earlier been evaluated in 1000 subjects in the Phase I and Phase II of the clinical trials.