Bharat Biotech has announced the successful recruitment of 13,000 volunteers, and continued its progress towards achieving its goal of 26,000 participants for phase-3 clinical trial across multiple sites in the country of India’s first Make in India vaccine candidate, Covaxin, against the coronavirus disease (Covid-19).
The phase-3 human clinical trials of Covaxin began mid-November, targeting 26,000 volunteers across the country at multiple sites.
“… this is India’s first and only Phase-3 efficacy study for a Covid-19 vaccine, and the largest phase -3 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 the company in a statement issued on Tuesday.
However, Bharat Biotech’s application for emergency use authorisation (EUA) clearance for their Covid-19 vaccine candidate is still pending with the national drugs regulator, Drugs Controller General of India, for want of adequate safety and efficacy data.
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, the only one of its kind in the world.
The vaccine candidate is a highly purified and inactivated two-dose Sars-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of at least 300 million doses.
“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 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,” said Suchitra Ella, joint managing director of Bharat Biotech, in a statement.
