Bharat Biotech in a statement issued on Saturday said the publication of its COVID vaccine’s phase II trial data is undergoing the peer review process and that as a part of the regulatory guidelines all data has been submitted to the DCGI and CDSCO.
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The firm said that product development and clinical trial data for Covaxin has so far generated five publications, four of which have been accepted by international peer reviewed journals and will be published soon.
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“Bharat Biotech has announced successful recruitment of 23,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of COVAXIN across multiple sites in India. The Phase III human clinical trials of COVAXIN began mid-November, targeted to be done in 26,000 volunteers across India. This is India’s first and only Phase…