Bharat Biotech recruits 23,000 volunteers for Phase III trials of Covaxin
Image Source : FILE PHOTO Bharat Biotech recruits 23,000 volunteers for Phase III trials of Covaxin
Bharat Biotech on Saturday introduced profitable recruitment of 23,000 volunteers, and continued progress in direction of attaining the purpose of 26,000 individuals for phase-III scientific trial of its coronavirus vaccine ‘Covaxin’ throughout a number of websites in India. The phase-III human scientific trials of Covaxin started mid-November, focusing on 26,000 volunteers throughout India. This is India’s first and solely part III efficacy examine for a Covid-19 vaccine, and the biggest part III efficacy trial ever performed for any vaccine in India, the Hyderabad-based firm stated.
“We thank every volunteer who has taken the time to participate in this trial. Their volunteering spirit is a great morale boost for India and the world. We thank all the principle investigators, doctors, medical staff, and the hospitals for their cooperation and 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,” stated Suchitra Ella, Joint Managing Director, Bharat Biotech.
Covaxin has been evaluated in roughly 1,000 topics in Phase I and Phase II scientific trials, with promising security and immunogenicity outcomes, with acceptance in worldwide peer reviewed scientific journals.
The product growth and scientific trial information so far has generated 5 publications, of which 4 have been accepted by worldwide peer reviewed journals and will likely be printed quickly.
“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 Drugs Controller General of India (DCGI) and Central Drugs Standard Control Organisation(CDSCO).”
Covaxin is a extremely purified and inactivated 2-dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with a wonderful security observe report of greater than 300 million doses.
India’s first indigenous Covid-19 vaccine by Bharat Biotech is developed 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, a one-of-its-kind facility on this planet.
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