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Bharat Biotech has recruited 23,000 volunteers so far for the Phase III clinical trials of its Covid19 vaccine candidate, Covaxin.
The Hyderabad-based vaccine maker has a goal of roping in 26,000 participants for Phase-3 clinical trials which are currently underway across multiple sites in India. The Phase III human clinical trials of Covaxin began mid-November 2020.
This is India’s first and only Phase-3 efficacy study for a Covid19 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.
It is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). 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.
``We thank all the Principal Investigators, Doctors, medical staff & the hospitals for their cooperation & support in taking the phase III trials forward in 26,000 volunteers in India. We continue our progress towards achieving the goal of 26,000 participants for Phase-3 clinical trials of Covaxin,'' Suchitra Ella, Joint Managing Director of Bharat Biotech said in a release on Saturday.
The product development and clinical trial data thus far has generated 5 publications, 4 of which have been accepted by international peer reviewed journals and will be published soon.
The publication of phase II trial data is undergoing the peer review process. As a part of our regulatory guidelines, all data has been submitted to the DCGI and CDSCO, the company said.
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