The All India Institute of Medical Sciences (AIIMS) will start human trials of coronavirus vaccine candidate COVAXIN developed by Bharat Biotech on Monday. Dr Sanjay Rai, Professor at Centre for Community Medicine at AIIMS said that an ethics committee has approved the trials. "Today, we got approval from AIIMS Ethics Committee for starting the human clinical trial of the indigenously developed Covaxin. We are launching the enrollment process from Monday. We are going to select healthy participants with no comorbidities and without a history of Covid-19. The age group of the study population is 18 to 55 years. This would be a randomised, double-blind, placebo-controlled clinical trial," Dr Rai said.
Drug regulator Drug Controller General of India had recently given the nod to conduct human trials for Bharat Biotech's COVID-19 vaccine candidate. The vaccine has been developed in collaboration with ICMR and National Institute of Virology (NIV).
Dr Rai said that any healthy individual who wishes to be included in the trial can send in an email on Ctaiims.email@example.com or send an SMS or call on 7428847499. Only 100 participants out of the 375 volunteers would be picked for the first and second phases. The rest would participate in trials at other sites. ICMR had approved 12 sites for the trials of COVAXIN. AIIMS Patna has started trials.
ICMR Director General Dr Balram Bhargava had earlier said that there are two coronavirus candidates in the country. Scientists are trying their best to fasttrack these vaccines. "There are two Indian indigenous candidate vaccines and they have gone successful toxicity studies in rats, mice and rabbits. The data was submitted to the Drugs Controller General of India (DCGI) following which both these candidate vaccines got clearance to start the early phase of human trials," he had said.
The other COVID vaccine candidate to have been approved for human trials is Zydus Cadila's.