Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials
Hyderabad: Bharat Biotech has successfully recruited 23,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of its COVID-19 vaccine Covaxin across multiple sites in India, it said.
The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers and it is the country'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, a press release from the vaccine maker said on Saturday night.
Thanking volunteers for their participation in the trials, Suchitra Ella, Joint Managing Director of Bharat Biotech said,the volunteering spirit is a great morale boost for India and the world.
"We thank all the principal investigators, doctors, medical staff & 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," she 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.
It is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
The indigenous, inactivated vaccine is manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility here, one of its kind in the world.