31 Oct 2020: AIIMS to submit proposal for COVAXIN's phase three trials soon
The Drugs Controller General of India has last week given approval to the company to conduct the phase three trials of its potential vaccine.
AIIMS is one of the sites selected for the trials.
Statement: Proposal is being prepared, confirmed AIIMS official
"The proposal is being prepared for the phase three trials, and within a couple of days we will be submitting it to the institute ethics committee for approval," he said.
Unless the institute ethics committee gives a clearance, trials can't commence.
Length: Proposal will be 200-300 pages long: Dr. Rai
Dr. Rai revealed that the proposal will run into 200-300 pages. "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," he added.
For the earlier phases, Dr. Rai's team submitted proposals on June 30 and got approvals on July 18.
Series of events: No safety concerns raised after phase one of trials
After phase one trials, no safety concerns were raised about COVAXIN.
The safety test for phase two has been finished, while the immunogenicity test, to judge the body's response to the vaccine, is underway, said the daily.
For phase three, Bharat Biotech hopes to recruit 26,000 participants across 25-30 hospital sites in 13-14 states. AIIMS is planning to test the vaccine on 2,000-5,000 participants.
Details: COVAXIN uses an inactivated Sars-Cov-2 virus
Bharat Biotech has partnered with the National Institute of Virology, one of the translational science cells of ICMR. The potential vaccine uses an inactivated Sars-Cov-2 virus and would require two doses, to be administered within a gap of 14 days.
COVAXIN is India's first vaccine candidate.
Naturally, the success of the phase three trials will determine the efficiency of the vaccine.