Bharat Biotech on Tuesday announced successful recruitment of 13,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for Phase III clinical trial of its coronavirus vaccine Covaxin across multiple sites in India.
The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers across India. Suchitra Ella, Joint Managing Director of Bharat Biotech termed this as an unprecedented vaccine trial ever in India. She said they were 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."
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. 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, 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.
