No adverse developments during Covishield vaccine trials in Mysuru

Medical data collected from volunteers is expected to be collated at the end of 28 days before phase three trials are taken up

Updated - September 09, 2020 08:52 pm IST

Published - September 09, 2020 05:03 pm IST - MYSURU

The clinical trials of Covishield, the potential vaccine developed by Oxford University and multinational pharmaceutical company AstraZeneca, are continuing unhindered at JSS Academy of Higher Education and Research (JSSAHER) in Mysuru.

Covishield has been administered to about 25 volunteers at JSS Hospital in Mysuru after phase two trials began on August 29. “No adverse events have been reported as of now”, Pro Chancellor of JSSAHER B. Suresh told The Hindu on Wednesday when his attention was drawn to the reports of AstraZeneca putting the trials on a temporary hold in U.K. after a volunteer developed “unexplained illness”.

“Sometimes sensitivity in individuals may vary and evaluation is done to assess the risk versus benefit analysis. They (AstraZeneca) must be evaluating the data for taking further steps”, Dr. Suresh said while making it clear that JSSAHER, which is one of the four centres carrying out the clinical trials of Covishield in India, had not received any directions from the authorities so far.

The volunteers were inoculated at JSS Hospital in Mysuru after Pune-based Serum Institute of India (SII), which has partnered with Oxford University and AstraZeneca to manufacture the vaccine, supplied the potential vaccine.

The medical data collected from the volunteers, who are being monitored, is expected to be collated at the end of 28 days before phase three trials are taken up.

“Our phase three is yet to start. The Drug Controller General of India (DGCI) gives approval for phase three only after analysing the phase two data, which will be available by the end of this month”, Dr. Suresh said.

The volunteers, who had been administered with the vaccine candidate in phase two trials, will be monitored for “fever, allergy and side effects” and dealt with if any issues arise.

The 25 volunteers in Mysuru are part of the 100 volunteers in the phase two trials of Covishield across India and JSSAHER is one of the four centres in the country selected for the trials. In phase three trials, the number of volunteers is expected to go up to 1,100 and correspondingly the number of persons receiving the potential vaccine in JSSAHER in Mysuru is also expected to increase to about 250.

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