The pace of infection of the coronavirus in the country has decreased compared to earlier, but the risk of the virus has not yet been avoided. Scientists around the world are engaged in the manufacture of vaccines to find the virus.
The All India Institute of Medical Sciences (AIIMS) may present the Corona Virus Vaccine 'Covaxine' being prepared by Bharat Biotech to the institute's 'Ethics Committee' early next week to start the Phase III clinical trial in the hospital. To get permission.
Bharat Biotech received approval from the Drug Controller General of India last week for a Phase III clinical trial of the Kovid-19 vaccine prepared by it. AIIMS Delhi is also one of the centers for conducting tests across India.
Professor Dr. Sanjay Rai of AIIMS Delhi's Department of Community Medicine confirmed that the proposal for Phase III trials is being prepared and within a few days we will submit it to the Institute's 'Ethics Committee' for approval. Dr. Rai is also the lead investigator for 'covaxine' tests at the hospital.
It is mandatory to get the approval of the 'Ethics Committee' of the institute to start testing at any of the approved sites. As per the rules laid down by the Indian Council of Medical Research (ICMR), which is the biomedical research regulator of the country, the 'Ethics Committee' is required to oversee clinical research and allow any approval before allowing the test to begin Do a thorough review of the proposal at the site.
AIIMS 'Ethics Committee' has 15 members and it is expected to take about 10-14 days to get the necessary approvals. Dr. Rai said, the proposal will be at least 200-300 pages and it takes time to go through it properly. The idea is to review the gap and see if all concerns are addressed.
Dr. Rai's team submitted the proposal to the committee on 30 June for the first and second phase trials and it got an approval on 18 July. AIIMS plans to recruit 2,000 to 5,000 participants for the upcoming Phase III trial as soon as it is approved by the 'Ethics Committee'.