Hyderabad-based Bharat Biotech has received approval to conduct phase II trials of its COVID-19 vaccine Covaxin from September 7.
The Directorate General of Health Service said in a statement: “This is to inform you that the subject proposal was examined in consultation with SEC (COVID-19) experts held through virtual meeting on September 3, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised in 4 days.”
Preparations were underway for the commencement of the phase II of human clinical trial of ‘Covaxin’, India’s indigenous COVID-19 vaccine. “The Phase I of the trial is still continuing as we are planning for the start of the Phase II trial shortly,” Dr E Venkata Rao, Principal Investigator of the trial at Institute of Medical Sciences and SUM Hospital, faculty of medical sciences told PTI.
The blood samples collected from the volunteers who received the vaccine were to ascertain how effective the vaccine was in terms of the level of antibodies developed, Dr Rao said, adding that there had been ‘no side effects’ in the first phase trial of the vaccine.