Bharat Biotech begins phase-3 trials of Covid-19 vaccine |
In the largest Clinical trial conducted for a COVID-19 vaccine in India, the leading drug maker Bharat Biotech has begun the phase 3 trials of its Covid-19 vaccine candidate, Covaxin, in India. The phase-3 clinical trials will involve 26,000 participants across 22 sites in the country. The trial will be conducted in partnership with the Indian Council of Medical Research (ICMR). This is India`s first phase 3 efficacy study for a coronavirus vaccine. The trial has been registered with the clinical trials registry of India and approved by the Drugs Controller General of India DCGI. Trial volunteers will receive two intramuscular injections about 28 days apart. Participants will be randomly assigned to receive Covaxin or 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 Phase II clinical trials, with promising safety and immunogenicity data. Covaxin, India`s indigenous Covid-19 vaccine, by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research and the 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.
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