The third phase of the human trial of the indigenously developed COVID-19 ‘Covaxin’ vaccine will soon begin at the Institute of Medical Sciences (IMS) and SUM Hospital in Odisha.
IMS and SUM Hospital are on the list of 21 medical institutes selected across the country by the Indian Council for Medical Research (ICMR) where the third phase of the trial would take place. It is the only institute in Odisha that has been selected for trial.
Speaking about the third phase, Dr. E Venkata Rao, principal investigator in the Covaxin human trial and professor in the Department of Community Medicine at IMS and SUM Hospital, said that the indigenous vaccine, which is being developed by ICMR and Bharat Biotech , has received approval from the Central Drug Standard Control Organization (CDSCO) to initiate the third phase of the trial.
“After completing the first and second phases of the trial with a demonstrable safety and immunogenicity profile, the large-scale efficacy trial involving thousands of volunteers is now planned,” added Dr. Rao.
He said volunteers would be followed for a considerable period of time to see how effective the vaccine was.
“The age limit and eligibility / detection criteria would be relaxed and several otherwise apparently healthy volunteers would be recruited for the trial. As in previous phases, half of the volunteers would receive placebo and the remaining half would receive Covaxin in this phase … even health workers would be recruited for the trial. Volunteers would be followed for a considerable period of time to observe the efficacy of the vaccine in preventing the development of coronavirus disease, “he said.
Dr. Rao added that there has been a great response and enthusiasm from the people who volunteered for the trial.
“Volunteers interested in the project could register themselves for the trial by registering online at www.ptctu.soa.ac in the registration section for clinical trials,” he said.
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