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 III efficacy study for a COVID-19 vaccine, and the largest Phase III efficacy trial ever conducted for any vaccine in India. COVAXIN has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals,” the company said in its statement.
It added that COVAXIN is India’s indigenous COVID-19 vaccine by Bharat Biotech and is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
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This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility, one of its kind in the world. It is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.
