Bhubaneswar: The third phase human trial of indigenously developed COVID-19 vaccine 'Covaxin' will soon commence at the Institute of Medical Sciences (IMS) and SUM Hospital in Odisha.
IMS and SUM Hospital is in the list of 21 medical institutes selected across the country by the Indian Council for Medical Research (ICMR) where the third phase trial would be conducted.
It is the only institute in Odisha which has been selected for the trial. The permission for the Phase III trials is subject to minor changes in the primary efficacy endpoint for the symptomatic cases.
The permission was granted to the vaccine maker to start Phase-III trials after it assessed data from the Phase-I and II trials along with the animal challenge study, sources said.
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, being developed by ICMR and Bharat Biotech, has received the approval of the Central Drugs Standard Control Organisation (CDSCO) for initiating the third phase trial.
"After completion of the first and second phase of the trial with demonstrable safety profile and immunogenicity, the large scale efficacy trial involving thousands of volunteers has been planned now," Dr Rao added.
He said the volunteers would be followed up over a considerable period of time to look at the efficacy of the vaccine.
"The age limit and eligibility/screening criteria would be relaxed and several volunteers who are otherwise apparently healthy would be recruited for the trial. Like the previous phases, half of the volunteers would receive placebo and the remaining half would be administered Covaxin in this phase. Even healthcare workers would be recruited for the trial. The volunteers would be followed up over a considerable period of time to look at the efficacy of the vaccine in preventing the development of the coronavirus disease," he said.
Dr Rao added that there had been a huge response and enthusiasm among people who had offered themselves to be volunteers for the trial.
"The interested volunteers for the project could enroll themselves for the trial by registering online at www.ptctu.soa.ac under the section register for clinical trials," he said.
Around 28,500 people are expected to enroll for the Phase-III trials in the country who would be given two doses of the investigational vaccine.
(With inputs from ANI)
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