IT Correspondent
Pune/New Delhi, July 19:
With its Ethics Committee giving approval the All India Institute of Medical Sciences (AIIMS), Delhi is set to start human clinical trials of the indigenously developed COVID-19 “Covaxin, from Monday onwards.
The Ethics Committee gave its nod on Saturday for trials of ”Covaxin”, developed by the Hyderabad-based “Bharat Biotech” in collaboration with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV), Pune. The Drugs Controller General of India (DCGI) has already given approval for clinical trials earlier.
AIIMS-Delhi is one of the 12 sites selected by the ICMR for conducting phase I and II human trials. In phase I, the vaccine would be tested on 375 volunteers, of whom at least 100 would be from AIIMS. The first phase the trials would be conducted on 375 participants across 12 clinical trial sites in the country. The AIIMS Patna and PGIMS Rohtak–have recently begun the vaccination process.
Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS, New Delhi said that the healthy volunteers having no co-morbid conditions and without a history of COVID-19, aged more than 18 years and less than 55 years, would be eligible to participate in the randomised, double-blind, placebo-controlled clinical trial. A few volunteers have already registered for the trial. Anybody willing to participate in the trial can send an email to [email protected] or an SMS to or call on 7428847499, he added.
The DCGI has permitted two vaccines — one developed by the “Bharat Biotech International Limited” in collaboration with the ICMR and another one by “Zydas Cadila Healthcare Ltd”, Ahmedabad, for human clinical trials in two phases.ICMR Director General Dr Balram Bhargava said that these two vaccine candidates have successfully undergone toxicity studies in rats, mice and rabbits.
Covaxin is an “inactivated” vaccine, which is made from using particles of the COVID-19 virus that were killed so that they would not be able to infect or replicate in those injected with it. Injecting particular doses of these particles serves to build immunity by helping the body create antibodies against the dead virus.
Zydus Cadila’s ”ZyCov-D” is a “plasmid DNA” vaccine which use genetically engineered plasmids, that are coded with the antigen (a toxin or substance given off by the virus). The DNA sequence injected would match that of the virus, helping the body build antibodies against it.
Both Bharat Biotech and Zydus Cadila began vaccinating participants on 15 July. The “ZyCov-D” phase I and II trials target 1,048 participants and are to be conducted at one site–Zydus Research Centre in Ahmedabad. “Zydus Cadila”, plans to conduct trials in phase I and II on 1,048 participants at one site–Zydus Research Centre in Ahmedabad.
The first phase “Covaxin” trials are expected to take over a month to complete, after which the data from the first trial will be submitted to the DCGI. After that trials for phase II will start. Both phases of the trial are expected to take around 15 months to complete. ZyCov-D’s first phase of trials is expected to take nearly three months to complete, following which the vaccine will move on to the second phase. Both phases of the trials are expected to take a year to complete.
Besides “Covaxin” and “ZyCov-D”, the DCGI has permitted the Pune- based “Serum Institute of India”(SII) to develop “pneumococcal vaccine” for which SII, has partnered with AstraZeneca, UK. The SII plans to make millions of doses over the next three months after it gets the manufacturing license, SII CEO Adar Poonawalla said.
