BHUBANESWAR: The third phase human trial of indigenously developed Covid-19 vaccine Covaxin will soon commence at the Institute of Medical Sciences and SUM Hospital here. The institute is one among 21 medical facilities across the country and the only in Odisha to be selected by the Indian Council of Medical Research (ICMR) for the third phase trial. Although the first phase human trial of the vaccine was successfully conducted at IMS and SUM Hospital as more than 20 volunteers received the shots, the institute had to do away with the plan for the second phase after the ICMR decided to reduce the number of facilities where the vaccine will be administered.
Principal investigator and Professor of department of Community Medicine at IMS and SUM Hospital Dr E Venkata Rao said the vaccine developed by ICMR and Bharat Biotech has received the approval of the Central Drugs Standard Control Organisation for the third phase trial. After completion of the first and second phase trials with demonstrable safety profile and immunogenicity, the large scale efficacy trial involving thousands of volunteers is being planned, he said.
“The age limit and eligibility criteria would be relaxed during this phase. Several volunteers who are 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. Health care workers would also 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 Covid-19,” Prof Rao said.
The institute has a list of individuals, who have already volunteered for the trial. Interested volunteers can also enrol for the trial by registering online at www.ptctu.soa.ac.in under the section register for clinical trials. They will be selected after a thorough screening.
IMS and SUM Hospital was one among 12 sites across the country where first phase trial was conducted. Hyderabad-based Bharat Biotech was first to secure the approval from the Drug Controller General of India to conduct clinical trials of Covaxin, making it the country’s first domestic vaccine to enter trials. “Amid the rising cases and deaths due to Covid-19 across the country, the search for a suitable vaccine candidate has almost come to the final stage,” Prof Rao added.