India’s first home grown COVID-19 Vaccine, which was developed by Bharat Biotech and the Indian Council of Medical Research, had entered clinical trials a few months ago. The primary phase I trials were conducted at several states in the country.
According to IANS, the vaccine is now ready and set for stage II of clinical trials. The second phase is likely to begin on Monday, September 7. "This is to inform you that the subject proposal was examined in consultation with SEC (COVID-19) experts held through virtual meeting on 03-09-2020, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised to 4 days," read the letter dated September 3.
The Joint Drugs Controller has had no objection in taking it forward and conducting the trial which is titled, 'An adaptive, seamless Phase I, followed by Phase II randomized, double-blind, multicentre study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy volunteers'.
Phase I trials began on July 15 and 350 people were administered with the vaccine. The volunteers were examined every two days. However, in phase II, volunteers will be examined every one in four days according to a report published by Times Now.
Reports have however stated that the phase I trials of Covaxin has produced good results. It has been both safe and effective.
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