After the All India Institute of Medical Sciences (AIIMS) Ethics Committee's approval on Saturday, the human trials of India's indigenously developed COVID-19 vaccine candidate, Covaxin, will start at the institute today. Under this, the institute will start enrolling healthy individuals for trials, few of whom have already registered.
Covaxin is being jointly developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). It recently received the nod for human clinical trials from the Drugs Controller General of India (DCGI).
Screenings to assess individuals' health conditions will start on Monday, Dr. Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS, has said.
"Few volunteers have already registered for the trial. We will start screening individuals and evaluate their health condition from Monday onwards before vaccinating them," he added.
Notably, AIIMS-Delhi is among the 12 sites selected by ICMR to conduct phase I and II human trials of Covaxin. In phase I, the vaccine will be tested on 375 volunteers and a maximum of 100 of them will be from AIIMS.
"Healthy volunteers having no comorbid conditions and without a history of COVID-19, aged more than 18 years and less than 55 years, would be eligible to participate in a randomised, double-blind, placebo-controlled clinical trial," Dr. Rai said.
Talking about the ethics committee's approval, he said it raised some objections concerning protocol initially, but they were addressed, following which the final nod to start human trials was granted.
Notably, Covaxin is the first indigenous vaccine being developed by India. This is why it is the top priority project for the country right now and is being monitored at the top-most level of government," ICMR Director-General Dr. Balram Bhargava recently said in a letter to principal investigators of the 12 sites.
AIIMS-Delhi is among the 12 ICMR-selected sites for phase I and II human trials of Covaxin; AIIMS-Patna and some more sites have already started human trials.
The phase-1 clinical trial of the Bharat Biotech vaccine started on July 15. It will be a randomised, double-blind, placebo-controlled clinical trial. It will involve a total sample size of 1,125 healthy volunteers in two phases (phase 1 and 2), with 375 in phase-1 involving age groups of 18-55, and 750 volunteers in the age group 12-65 in the phase-2 study.
As per Bharat Biotech, the study is "designed to evaluate the safety, reactogenicity, tolerability, and immunogenicity of three groups of healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations." This further puts the estimated duration of trials as one year and three months.
Normally, there is also a phase 3 on a much larger group of people, but there is no information on this. Therefore, experts and those in the vaccine development space feel it may be reasonable to assume that it may well be by the end of 2021, if not early 2022 before the vaccine may be ready.
Apart from Covaxin, the DCGI has also permitted Zydas Cadila Healthcare Ltd to go in for phase I and II human clinical trials.
India is the third most-affected country due to coronavirus pandemic after the US and Brazil, with a total of 10,77,618 cases, including 3,73,379 active cases and 26,816 deaths.
Edited by Manoj Sharma with PTI inputs