New Delhi: Bharat Biotech’s covid19 vaccine Covaxin has got permission for second round of trials on humans. Phase 2 trial of this indigenous potential vaccine will begin in the coming week. According to the report, approval has been received from the Drug Controller General of India (DCGI) for this. The report said that the Subject Expert Committee recommended that this time 380 people should be tried.
The company has been informed about this in a letter issued on 3 September by Dr. S. Ishwara Reddy, Controller of Drugs. Covaxin is developed jointly by ICMR and Bharat Biotech. It is an inactivated vaccine. It will work on giving doses of such viruses, which are not active and there is no danger to humans. This vaccine enables the body to make antibodies to fight these inactive viruses.
In the first phase trial, the focus was on the safety of healthy participants. It was tried on 375 people across the country. The vaccine will be judged to be effective in the second phase of trials. Safety and effectiveness of the vaccine will be judged on a large population of the country in the third and last phase trials.
