BHUBANESWAR: The Institute of Medical Sciences (IMS) and SUM Hospital is out of the race for the second phase trial of India’s indigenous Covid-19 vaccine Covaxin. The city-based health facility, which had conducted the phase 1 trial of the vaccine, is not in the list of institutes shortlisted for the phase 2 trial.
Although the institute had made elaborate arrangements and received a number of applications from volunteers following success of the first phase trial, it had to do away with the plan after the ICMR decided to reduce the number of facilities where the vaccine shots will be administered.
In the first phase, 12 sites were selected across the country for human clinical trial of Covaxin developed by Hyderabad-based Bharat Biotech International.
“The number of sites came down after the vaccine protocol was changed and it was decided that 380 samples of the vaccine will be put to tests instead of more as planned earlier. The institutes, which got themselves ready with the revised protocol and got the permission of their respective ethical committees, were given the nod for the phase 2 trial,” said an official of the SUM Hospital.
As many as 375 volunteers were administered the vaccine in the first phase and more than 20 received the shots at the IMS and SUM Hospital between July 27 and August 15. “The candidates who were injected the vaccine have completed 42 days and they are absolutely fine. There has been no sign of any adverse symptom. All 375 volunteers are well and good. The vaccine seems to be safe to use,” the official informed.