Bharat Biotech on Saturday announced successful recruitment of 23,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for phase-III clinical trial of its coronavirus vaccine ‘Covaxin’ across multiple sites in India.
The phase-III human clinical trials of Covaxin began mid-November, targeting 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, the Hyderabad-based company said.
“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,” said Suchitra Ella, Joint Managing Director, Bharat Biotech.
Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals.
The product development and clinical trial data thus far has generated five publications, of which four 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 Drugs Controller General of India (DCGI) and Central Drugs Standard Control Organisation(CDSCO).”
Covaxin is a highly purified and inactivated 2-dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more 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 in the world.