Bharat Biotech that is currently in the testing phase for its coronavirus vaccine Covaxin has said that it has successfully recruited 13,000 volunteers. It is aiming to eventually recruit 26,000 participants for its large-scale Phase 3 clinical trial that is being conducted across multiple sites in the country.
"This is an unprecedented vaccine trial ever to take place in India, and we are overwhelmed with the steady rise in participation. We sincerely thank all the 13,000 volunteers across the country for their support in enabling us to bring out a safe and efficacious Indian vaccine for Covid-19," said Suchitra Ella, Joint Managing Director of Bharat Biotech.
The Phase 3 clinical trials of Covaxin began in mid-November with a target of 26,000 volunteers. Bharat Biotech's is the first and only Phase 3 efficacy study for a vaccine developed in the country. So far in Phase 1 and 2, 1,000 subjects were evaluated. The results showed safety and efficacy of the vaccine.
Developed by Bharat Biotech along with Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV), Covaxin is India's first indigenous coronavirus vaccine. The vaccine has been developed in the company's BSL-3 (Bio-Safety Level 3) biocontainment facility.
Bharat Biotech has also applied for emergency use authorisation (EUA) clearance for the coronavirus vaccine candidate. However, the application is still pending with Drugs Controller General of India for want of adequate safety and immunogenicity data.