Two volunteers were administered COVAXIN, the indigenous vaccine for coronavirus, in Hyderabad's Nizam's Institute of Medical Sciences (NIMS) as human trials begin, on Monday. They are stable so far, doctors said.
“The trial is so far successful. The volunteers are healthy. They did not have any abnormal reaction,” said Dr Lakshmi Bhaskar, who is one of the members of the team conducting the trials.
Dr Lakshmi Bhaskar added that the volunteers would be kept under observation until Tuesday morning, and the trials would be conducted on four more volunteers who would be administered the vaccine as well.
NIMS was one among the 12 institutes selected to conduct clinical trials.
COVAXIN is an indigenous vaccine developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) and National Institute of Virology (NIV).
The vaccine, which is currently undergoing clinical trials, recently received approval for human trials from the Drugs Controller General of India (DCGI), India’s drug regulator.
COVAXIN is made from an inactivated vaccine developed from a strain of the novel coronavirus, which was isolated by NIV, Pune. After receiving the virus strain from NIV, Bharat Biotech developed the first GMP (good manufacturing practices) of COVAXIN within 40 days and started pre-clinical trials.
Before the trials on humans, COVAXIN was evaluated on animals in which it was found to be safe and immunogenic.
Speaking to the media earlier, Dr Krishna Ella, Managing Director and Chairperson of Bharat Biotech explained how the vaccine would work.
“Since it’s a killed virus in the vaccine, it does not multiply. But the body thinks that there is a virus and starts producing antibodies. Once the immune response is produced, we draw the blood sample,” Dr Krishna had said.
According to Dr Krishna, the blood sample is drawn from the person who has been administered the vaccine on the 28th day of Phase One trials, and the sample is then sent to their lab. At the lab, the active virus is introduced to the blood sample. If the virus does not multiply at all, this means that it has been neutralised, Dr Krishna said.