Bharat Biotech on Thursday announced “successful completion” of volunteer enrolment for Phase-3 clinical trials of its indigenously manufactured 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 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.
On January 3, the Drugs Controller General of India (DCGI) had approved Oxford Covid-19 vaccine Covishield, manufactured by the Serum Institute, and Bharat Biotech’s Covaxin for restricted emergency use in the country, paving the way for a massive inoculation drive.
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.”
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.