Drugs Controller General of India has given permission to Bharat Biotech for doing Phase II human clinical trials of its Covaxin.
The report informed that the subject expert committee 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 the company about this.
EV Rao, Principal Investigator of the trial at the Institute of Medical Sciences and SUM Hospital, Faculty of Medical Sciences, said, “The Phase I of the trial is still continuing and we are planning to start Phase II trial shortly.”
Rao said that ‘no side effects’ were found in the vaccine’s phase 1 trial.
However the blood samples were collected from volunteers after receiving the COVID-19 vaccine. To have a idea how effective it was in terms of the development of antibodies.
“Two doses of the vaccine were administered to each volunteer. After they were selected through a screening process conducted over a period of three to seven days prior to vaccination. The first dose was administered on Day Zero while and the second dose was given on Day 14,” Rao added.
