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AIIMS ethics committee is likely to take around 10 to 14 days to grant the necessary approvals
31-10-2020

The All India Institute of Medical Sciences (AIIMS) in New Delhi is likely to submit a proposal to the Institute of Ethics Committee to start Phase 3 clinical trials of Bharat Biotech's Covid-19 vaccine candidate Covaxin by early next week.

Last week, Bharat Biotech received an approval from drugs controller general of India to begin Phase 3 trials of its coronavirus vaccine candidate Covaxin in India. AIIMS Delhi is one of the hospitals selected for the final-stage trials to be conducted across the country.

However, before allowing a trial to start at any of the approved sites, it�s compulsory to secure clearance of the Institute of Ethics Committee.�The proposal is being prepared for the phase 3 trials, and within a couple of days we will be submitting it to the institute ethics committee for approval,"quoted Dr Sanjay Rai, professor, department of community medicine, AIIMS Delhi, as saying.

AIIMS ethics committee, which consists of 15 members, is likely to take around 10 to 14 days to grant the necessary approvals.

Dr Rai, who is also the principal investigator for the Covaxin trials at the hospital said, �The proposal will be at least 200-300 pages and it takes time to go through it properly. The idea is to review and look for gaps, if any, that would address all concerns. The concerns that are usually raised almost always are valid, which you might miss otherwise. It helps."

Covaxin phase 1 and 2 clinical trials
For the Phase 1 and 2 clinical trials, Dr Rai�s team had submitted the proposal to the committee on 30 June following which the clearance came on 18 July.

Meanwhile, AIIMS Delhi plans to recruit between 2,000 and 5,000 participants for the phase 3 trial, the report added.

According to reports, Bharat Biotech had submitted the Phase 3 trial application for India to the national drugs controller on 2 October, and received its approval on 22 October, suggesting minor procedural changes to the trial plan.

The firm aims to enroll 26,000 participants for the Phase 3 clinical trials at 25 to 30 hospital sites across 13 to 14 states.

For Phase 1 trials, Bharat Biotech had recruited 375 subjects, and as part of the Phase 2 trials, the vaccine candidate was administered to 400 participants.

�Phase 3 trial results will eventually decide which vaccine would work and which wouldn�t," Dr GC Khilnani, former head, pulmonary medicine department, AIIMS, Delhi told reporters.