Hyderabad-based Bharat Biotech Recruits 23,000 Volunteers for Phase III Trials of Covaxin

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 assessed in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising



security and immunogenicity results, with acknowledgment in global friend reviewed scientific journals. 

The item advancement and clinical trial information so far has produced five publications, of which four have been acknowledged by global friend reviewed journals and will be distributed soon. 

"The publication of phase II trial information is going through the friend audit measure. As a piece of our administrative rules, all information has been submitted to the Drugs Controller General of India (DCGI) and Central Drugs Standard Control Organization (CDSCO)." 

Covaxin is an exceptionally cleansed and inactivated 2-portion SARS-CoV-2 immunization, manufactured in a Vero cell manufacturing platform with an amazing security history of in excess of 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.