Bharat Biotech has successfully recruited 23,000 subjects for the Phase 3 clinical trial of its coronavirus vaccine candidate Covaxin. The company said that it is steadily moving towards its goal of 26,000 volunteers. The statement by the company comes as an expert panel of India's central drug authority recommended granting permission for use of Covaxin in emergency situation.
Suchitra Ella, Joint Managing Director of Bharat Biotech said, "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 Principal 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. We continue our progress towards achieving the goal of 26,000 participants for Phase-3 clinical trials of Covaxin."
Phase 3 of human clinical trials for Covaxin began in mid-November. However, as per reports the company faced challenges in recruiting 26,000 volunteers for the largest efficacy trial conducted for any vaccine in India. The coronavirus vaccine was evaluated approximately in 1,000 subjects in Phase I and 2 trials that showed positive safety and immunogenicity results.
The product development and clinical trial data will soon be published in international peer reviewed journals. All data has been submitted by the company to the Drugs Controller General of India (DCGI) and Central Drugs Standard Control Organisation (CDSCO).
Developed in Bharat Biotech's BSL-3 bio-containment facility, Covaxin is India's first indigenous vaccine developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
Meanwhile, on Saturday, the Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation gave its approval to Covaxin coronavirus vaccine for emergency use. This makes it the second vaccine after Serum-AstraZeneca's Covishield to get marketing approval from the expert panel.