Hyderabad (Telangana) [India], January 2 (ANI): Bharat Biotech has recruited 23,000 volunteers so far for the Phase III clinical trials of its COVID-19 vaccine candidate, 'COVAXIN'.
"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 coronavirus vaccine "COVAXIN" across multiple sites in India," an official statement read.
COVAXIN, India's 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, one of its kind in the world.
The phase III human clinical trials of COVAXIN began mid-November, targeted to be done in 26,000 volunteers across India, according to the Bharat Biotech.
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, it said.
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 company said in a statement.
Suchitra Ella, Joint Managing Director of Bharat Biotech thanked 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," Ella said.
COVAXIN 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, the company said. (ANI)