Central Drugs Standard Control Organisation has approved phase II trials of Bharat Biotech's vaccine candidate Covaxin. After satisfactory results of Phase I clinical trial, DCGI has given permission for phase II trials of Covaxin, which is developed by Bharat biotech in alliance with the ICMR - National Institute of Virology.
The report informed that the subject expert committee (SEC) has recommended that the trial will be conducted on 380 participants. A letter from Joint Drugs Controller Dr S Eswara Reddy, dated September 3, has notified it to Bharat Biotech.
The letter said that directorate had no objection to conducting the trial titled 'An adaptive, seamless Phase I, followed by Phase II randomized, double-blind, multicentre study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy volunteers.
Phase I clinical trials of the vaccine began on 15th july at 12 centres across the country where healthy volunteers were administered two doses of vaccination shots with a gap of 14 days. These trials on 375 volunteers are still continuing.
The SEC also laid down the conditions that the trial sites should be different from the sites where the present clinical trials are going on for the vaccine through the intramuscular route and that the subject should be followed up for six months for clinical and antibody assessments.
