The Hyderabad-based vaccine company has received confirmation from the Central Drug Standard Control Organisation, under the Directorate General of Health Services to conduct the Phase II trials of the Covaxin. The approval letter was handed to Bharat Biotech by Joint Drugs Controller Dr. S. Eswara Reddy.
Bharat Biotech is in partnership with the Indian Council of Medical Research (ICMR) preparing a homegrown effective vaccine.
Institute of Medical Sciences (IMS) and SUM Hospitals in Bhubhaneshwar is one of the 12 institutes that are allowed to go ahead with the human trials.
Phase II of BBVI52, translated as COVAXIN, will be conducted of 380 humans who will be screened after 4 days of the vaccine given.
During the First Trials, blood samples collected from the volunteers who received the vaccine were monitored for side effects and according to Dr. E. Venkata Rao, Principal Investigator of the Trials in the IMS & SUM Hospitals, there were no side effects seen.
Covaxin is an ‘Inactivated’ vaccine – it works by injecting doses of the dead virus, aiming to trigger the body to build antibodies against it without the virus posing a threat.
Phase I was for determining safety which seems to be accomplished.
Phase II aims at the Vaccine’s effectiveness, which is set to begin from September 7.
