Covaxin Phase III Trials Halfway Through 13,000 Volunteers | India News
HYDERABAD: Covaxin, India’s first indigenous Covid-19 vaccine developed by Hyderabad-based Bharat Biotech, has managed to recruit 13,000 volunteers for its phase III trials, which is half the number of volunteers selected for the studies of effectiveness.
Phase III human clinical trials of Covaxin began in mid-November with NIMS Hyderabad, making them the first and only phase III efficacy studies for a Covid-10 vaccine in India.
The company plans to conduct the efficacy study on 26,000 participants at 25 sites across India, which is the largest Phase III efficacy trial ever conducted for any vaccine in the country.
Calling Covaxin’s efficacy trials unprecedented, Bharat Biotech Joint Managing Director Suchitra Ella said the company has been overwhelmed by the steady increase in participation. “We sincerely thank the 13,000 volunteers across the country for their support in enabling us to bring out a safe and effective Indian vaccine for Covid-19. This public health volunteerism in favor of vaccines is a morale booster for us to soon achieve our historic goal of 26,000. ”
Bharat Biotech said that Covaxin in its phase I and II clinical trials, which were evaluated in about 1,000 subjects, have shown promising results for safety and immunogenicity with acceptance in international peer-reviewed scientific journals.
Covaxin is being developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) – National Institute of Virology (NIV). It is a highly purified and inactivated two-dose SARS-CoV2 vaccine manufactured on a Vero cell manufacturing platform that has an excellent safety record of more than 300 million doses.
The indigenous inactivated vaccine has been developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) biocontainment facility.