Tribune News Service
New Delhi, December 22
Bharat Biotech on Tuesday announced successful recruitment of 13,000 volunteers and continued progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of COVAXIN across multiple sites in India.
The Phase 3 human clinical trials of India’s first indigenous COVID vaccine COVAXIN began in mid-November, targeted to be done on 26,000 volunteers across the country.
This is India’s first and only Phase 3 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.
COVAXIN, India’s indigenous COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) and 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 kinds 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.
Speaking on the occasion, Suchitra Ella, Joint Managing Director of Bharat Biotech, said, “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 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. Thank you volunteers, Thank you India.”
Bharat Biotech’s application for emergency use of COVAXIN in India is pending before the Drug Controller General’s office which has sought phase 3 efficacy data.