November 18, 2020 5:27:43 am
Bharat Biotech has announced the commencement of Phase III trials of COVAXIN. The Phase III trials will involve 26,000 volunteers across India and will be 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 III efficacy study for a Covid-19 vaccine. Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to receive COVAXIN or placebo. The trial is double blinded — the investigators, participants and the company will not be aware of who is assigned to which group.
COVAXIN has been evaluated in approximately 1,000 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 over 18 years of age.
Suchitra Ella, joint managing director of Bharat Biotech, said in a statement, “The development and clinical evaluation of COVAXIN™ marks a significant milestone for vaccinology in India for a novel vaccine… COVAXIN™ has garnered interest from several countries worldwide for supplies and introduction.”
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