Bharat Biotech has recruited 13,000 volunteers for Phase-3 clinical trial of its Covid-19 vaccine candidate Covaxin across multiple sites in India.
The human clinical trials of Covaxin began mid-November with a target of roping in 26,000 volunteers across India.
“This is an unprecedented vaccine trial 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. This pro-vaccine public health volunteerism is a morale booster for us to achieve our milestone target of 26,000 soon,” Suchitra Ella, Joint Managing Director of Bharat Biotech, said in a release on Tuesday.
This is India’s first and only Phase 3 efficacy study for a Covid-19 vaccine, and the largest Phase 3 efficacy trial ever conducted for any vaccine in India, said the release.
“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 Hyderabad-based company said.
Covaxin 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 developed and manufactured at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility.
It is a highly purified and inactivated two-dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, the release said.