Preparations are underway for the second phase of the human clinical trial of 'Covaxin'. Hyderabad-based Bharat Biotech, the maker of India's indigenous COVID-19 vaccine candidate, had recently received the Indian Council for Medical Research's (ICMR) approval to conduct trials across 12 medical centres in the country.
S Eswara Reddy, Joint Drugs Controller, in a letter to Bharat Biotech, conveyed the organisation's nod for starting phase II trials in India. These trials will be conducted on 380 volunteers, who will be screened for four days after receiving the vaccine shots.
The Institute of Medical Sciences and SUM Hospital in Bhubaneswar is one of the 12 medical centres chosen by the ICMR for conducting the human trial of the vaccine developed by Bharat Biotech.
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 'no side effects' were found in the vaccine's phase 1 trial. The blood samples were collected from volunteers after receiving the COVID-19 vaccine to ascertain 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.
Blood samples of the volunteers will also be collected on day 28, 42, 104, 194 for estimating the duration of protection, he added. Rao said there was a lot of enthusiasm among people to be a part of the second phase human trial.
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