Bharat Biotech on course to have 26,000 volunteers for Phase-3 clinical trials of Covaxin
The company statement has come after an expert panel of India’s central drug authority recommended granting permission for restricted use of Covaxin in emergency situation, especially in the context of infection by mutant strains.
The recommendation for Bharat Biotech’s vaccine came a day after the panel cleared the Serum Institute of India‘s emergency use authorisation application for the Oxford-AstraZeneca vaccine Covishield, paving the way for the rollout of COVID-19 shots in the country in the next few days.
Bharat Biotech, Serum Institute, and Pfizer had applied with the Drug Controller General of India (DCGI) for emergency use authorisation for their respective vaccines.
The Phase III human clinical trials of Covaxin, which began in mid-November last year, require 26,000 volunteers across India, Bharat Biotech said in a statement.
“This is India’s first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India. COVAXIN has been evaluated in around 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals,” it added.
The company has developed the vaccine 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, one of its kind in the world, it added.
“We thank every volunteer who has taken the time to participate in this trial. Their volunteering spirit is a great morale boost for India and the world. We thank all the principle investigators, doctors, medical staff and the hospitals for their cooperation and support in taking the Phase III trials forward in 26,000 volunteers in India,” Bharat Biotech Joint Managing Director Suchitra Ella said.
The company continues its progress towards achieving the goal of 26,000 participants for Phase-3 clinical trials of Covaxin, she added.