Srinagar, Dec 22 (KINS): Bharat Biotech has 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 III human clinical trials of COVAXIN began mid-November, targeted to be done in 26,000 volunteers across India, 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 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals,” said Bharat biotech.
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 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.(KINS)