Moving ahead with the testing of vaccines for the novel Coronavirus, Bharat Biotech will start the second phase of human clinical trials of its indigenously developed Covaxin in the coming week.
Moving ahead with the testing of vaccines for the novel Coronavirus, Bharat Biotech will start the second phase of human clinical trials of its indigenously developed Covaxin in the coming week. It has received clearance from the regulator body—Drugs Controller General of India, according to a report by The Indian Express. The report said that the subject expert committee (SEC), after evaluating the request to begin the advanced phase of COVID-19 vaccine trials, has recommended that the trial will be conducted on 380 participants. The company has been notified of this in a letter dated September 3 by Joint Drugs Controller Dr. S Eswara Reddy.
It is to note that Covaxin is known as an “inactivated” vaccine that will work upon injecting doses of the virus that are not active, and will not pose any threat to humans. However, this will enable the body to build antibodies against it. In the first stage of vaccine testing, the focus was on the safety of healthy participants. With the beginning of phase II trials, the effectiveness of vaccines will be mapped. In the third and last phase of vaccine trials, the safety and efficacy of vaccines will be checked in a large scale population in the country.
According to the report, the first phase of the Covaxin trial was done with 375 participants from across 12 sites. A PTI report citing Dr Rao noted that blood samples collected from the volunteers showed the level of antibodies formed, thus indicating the effectiveness of Covaxin. Further, there have been no side effects in the volunteers during the first phase of trials.
The vaccine is considered as the country’s most promising one and is a frontrunner among COVID-19 vaccines. Meanwhile, Zydus Cadila and Serum Institute of India have already started conducting phase II trials for their vaccine candidates ZyCoV-D and Covishield (by Oxford-AstraZeneca) in India.