Hyderabad-based vaccine maker Bharat Biotech on Tuesday announced successful recruitment of 13,000 volunteers and continued progress towards achieving the goal of 26,000 participants for the Phase 3 clinical trials of its COVID-19 vaccine 'Covaxin' across multiple sites in India.
Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, Bharat Biotech said in a statement.
The indigenously developed COVID-19 vaccine has been developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV), it added.
"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," Bharat Biotech said.
According to the company, the vaccine is developed and manufactured at Bharat Biotech's BSL-3, biocontainment facility.
“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 13000 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 – Thank you volunteers Thank you India,” Bharat Biotech Joint MD Suchitra Ella said.
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. 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.