Hyderabad-based Bharat Biotech starts phase III trials for Covaxin
The phase III trials will involve 26,000 volunteers across 25 centres in India, being conducted in partnership with ICMR
Hyderabad: Bharat Biotech has announced commencement of phase III trials of Covaxin. The phase III trials will involve 26,000 volunteers across 25 centres in India, being conducted in partnership with ICMR. It is the largest clinical trial conducted for a Covid-19 vaccine in India.
This is India’s first phase 3 efficacy study for a Covid-19 vaccine, and the largest phase III efficacy trial ever conducted in India. The trial has been approved by the Drugs Controller General of India.
Participating volunteers who undergo vaccination in the phase III trials, will be monitored over the next year to detect occurrence of Covid disease. Trial volunteers will receive two intramuscular injections approximately 28 days apart.
Participants will be randomly assigned 1:1 to receive either two 6 microgram (mcg) injections of Covaxin or two shots of a placebo. The trial is double-blinded, such that the investigators, the participants and the company will not be aware of who is assigned to which group.
Covaxin has been evaluated in about 1,000 subjects in phase I and II clinical trials, with promising safety and immunogenicity data. Volunteers who wish to participate in this trial should be adults over 18 years of age.
Covaxin, India’s indigenous Covid-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility.
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