Clinical trial of the Covishield vaccine, developed by the University of Oxford, began at the JSS Hospital in Mysuru, an official said on Sunday.
“The clinical trial of Covishield began on Saturday at our hospital, which is the only institute in Karnataka to have been selected by the Indian Council of Medical Research (ICMR) for verifying its effect and efficacy on a coronavirus patient,” the official told IANS here.
Similar trials are underway at 16 other institutes across the country. The 1,800-bed Jagadguru Sri Shivarathri (JSS) Hospital is run by the Suttur Mutt at Suttur village on the banks of the Kabini river in Nanjungud.
Once the trials in three phases are completed and submitted for validation, the Pune-based Serum Institute of India will produce the vaccine candidate in partnership with the British drug major AstraZeneca, which has its Indian operations in Bengaluru.
“The vaccine dose was administered to five persons who volunteered for the phase-2 trial after investigation and monitoring,” the official pointed out.
The trials began on the 105th jayanti mahotsava of Sri Shivarathri Rajendra Swami.
According to Pharmacy Council of India President B. Suresh, who is the pro-chancellor of the JSS Academy of Higher Education and Research, the vital parameters of the volunteers like body temperature, blood pressure and heart beats were checked before commencing the trial.
Besides Covishield, the Hyderabad-based Bharat Biotech’s Covaxin and Ahmedabad’s Zydus Cadila’s ZyCoV-D are also testing their vaccine candidates.
“As per the protocols of the ICMR, an apex body for the formulation, coordination and promotion of biomedical research, the volunteers will be given another dose 28 days later to test the vaccine’s safety aspects,a said the official.
The data of the trials will be sent to ICMR, which will collate similar data from 16 other clinical trial centres across the country and assess their effectiveness for production after certification by the regulator (Drug Controller General of India).
The team of doctors performing the Covid-19 trials is also doing BCG vaccine trials on select senior citizens for gathering data on its effect.
“The volunteers are also under observation to check any reaction or side-effects of the Covishield vaccine,” added the official.
Under ICMR’s supervision, the phase-2 trial is being conducted on about 100 volunteers in the 17 institutes across the country.
In the third and final phase of the trial, about 1,500 volunteers will be injected with the vaccine across the country and observed for generating antibodies. – Bangalore Mirror