Covaxin: Bharat Biotech completes volunteer enrollment for Phase 3 clinical trials
1 min read 07 Jan 2021, 04:06 PM ISTBharat Biotech successfully enrolled 25,800 volunteers for Phase 3 clinical trials of CovaxinThe phase one and two clinical trials on 375 and 380 participants respectively revealed very low adverse events, ICMR chief Dr Balram Bhargava said
PremiumBharat Biotech on Thursday announced "successful completion" of volunteer enrolment for Phase-3 clinical trials of its indegenously manufactures Covid-19 vaccine 'Covaxin.'
"COVAXIN successfully completes Phase 3 clinical trials enrolment of 25,800 volunteers," informed Suchitra Ella Joint Managing Director Bharat Biotech International Limited.
"We sincerely express our gratitude to clinical trial sites, Principle Investigators & healthcare workers for their relentless support and trust in our Public-Private Partnership vaccine discovery. My deep appreciation to all the volunteers for reposing trust and expressing Pro Vaccine Public Health Volunteerism in the Phase-3 Clinical Trials of India's 1' fully indigenous COVID-19 Vaccine," she added.
The announcement came days after the Hyderabad-based vaccine manufacturer announced successful recruitment of 23,000 volunteers and continued progress towards achieving the goal of 26,000 participants for the phase 3 trial of its coronavirus vaccine candidate Covaxin in India.
In a statement, Bharat Biotech said that the Phase III human clinical trials of Covaxin began in mid-November. It is also the largest phase III efficacy trial ever conducted for any vaccine in the country, as per the statement.
Meanwhile, on 3 January, the Drugs Controller General of India (DCGI) had on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
Industry experts and some opposition leaders have expressed concern over the absence of Phase 3 trial data on Covaxin. The critics have cautioned that "sidestepping" processes and giving "premature" clearance could risk lives and fuel vaccine hesitancy in India.
The phase one and two clinical trials on 375 and 380 participants respectively revealed very low adverse events, ICMR chief Dr Balram Bhargava said, adding, "It showed neutralising antibody responses equivalent to human convalescent serum, strong antibody responses to all structural proteins... three months after vaccination."
The phase three clinical trial will include 25,800 participants of which 24,000 have been enrolled so far. There are no safety concerns. They (participants) have been given their first dose and more than 5,000 give the second jab, he said.
"Permission for restricted use in clinical trial mode has been allowed which means consent of participants has to be taken and there has to be a regular follow up of participants," Bhargava said.
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