Bharat Biotech's COVID-19 Vaccine enters the 3rd phase of clinical trials
The Bharat Biotech today has announced the commencement of Phase III trials of COVAXIN. The Phase III trials of its vaccine will involve 26,000 volunteers from across India and will be conducted in partnership with the Indian Council of Medical Research (ICMR). It'll reportedly be the largest clinical trial conducted for a COVID-19 vaccine in India. This is India’s first Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted in India. The trial has been registered at www.ctri.nic.in and has been approved by the Drugs Controller General of India. Trial volunteers will receive two intramuscular injections at approximately 28 days apart time interval. Participants will be randomly assigned to receive COVAXIN or the 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 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity data. Volunteers who wish to participate in this trial should be adults and over 18 years of age. COVAXIN is one of India's indigenous COVID-19 vaccines by Bharat Biotech and is being developed in collaboration with the Indian Council of Medical Research - National Institute of Virology. This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 biocontainment facility. COVAXIN is a highly purified and inactivated vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.