The Dhargal-based Redkar Hospital and Research Centre is targeting 100-125 volunteers for human clinical trials for developing a vaccine against SARS-CoV-2, the virus that causes the dreaded COVID-19.
It is pertinent to note that the RHRC is one of the 12 medical institutes across India selected by the Indian Council of Medical Research for clinical trials of developing indigenous COVID-19 vaccine named ‘Covaxin’.
The ICMR has partnered with the Bharat Biotech International Limited to fast track the clinical trials.
“Around 1,100 volunteers will participate in these clinical trials across the country. But they have not specified about the number of individuals to be enrolled at every centre. We are targeting 100-125 individuals and have already identified a few of them who are eligible to participate in the clinical trials,” Dr Sagar Redkar of the RHRC told ‘The Navhind Times’.
As per the new protocol of the ICMR, AIIMS Delhi, AIIMS Patna, Nizam’s Institute Of Medical Sciences, Hyderabad and Post Graduate Institute of Medical Sciences in Rohtak have been selected as the first four institutes to conduct the trials on first 50 volunteers.
“After testing the candidate vaccine on these 50 volunteers they will observe them for seven days. And after ensuring their safety the ICMR will ask other institutes to officially begin the enrollment of volunteers,” Dr Redkar
The volunteers will be screened two days before the enrollment, and all those who are healthy and found to be negative for COVID-19 by fulfilling the eligibility criteria laid down by the ICMR will be part of the clinical trials.
As per the new ICMR protocol, healthcare workers, including doctors and nurses, cannot participate as a subject in the clinical trials, he said, adding that the RHRC has completed all the required formalities and is fully prepared to conduct the trails.
“All the authorities, including the district collector, have been informed. We are waiting for communication from the ICMR after which we will begin the clinical trials,” he said.