Bharat Biotech’s Covid-19 vaccine Covaxin phase-3 trials crosses half-way mark at 13,000 volunteers
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 first Make in India vaccine candidate, Covaxin across multiple sites in India. 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 was evaluated in approximately 1,000 subjects in the first two phases, with the results receiving acceptance in international peer-reviewed scientific journals, a statement from Bharat Biotech said today.
"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," Suchitra Ella, Joint Managing Director of Bharat Biotech, said in the statement.
ALSO READ | Bharat Biotech's Covaxin 'well tolerated' in all dose groups, no serious adverse events in phase 1 trials
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.
Earlier, Sanjay Rai, the doctor who is the principal investigator (PI) of Covaxin trial, said that the rollout of Covid-19 vaccine by Bharat Biotech for the general public may get delayed as the All India Institute of Medical Sciences (AIIMS), where its Phase-III human clinical trial is underway, is struggling to find takers of the trial shots.
Rai, who also heads the Department of Community Medicine at AIIMS said in the Phase-III trials, around 80 per cent refusal rate was seen in the participation, whereas it was around 8 per cent for the earlier Phase I and II.
In Phase I and II, the clinical site had enrolled more than 800 candidates cumulatively while the target for phase III is around 1,500.
ALSO READ | Shortfall in Phase-III Covaxin trial target
