New Delhi: The clinical trials of Oxford COVID19 Coronavirus vaccine candidate which was expected to start at The Post Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh, appear to have been postponed by at least a week due to delay in safety approvals.
The Oxford COVID19 vaccine trials were expected to begin from September first week but have been delayed as safety approval is still pending from the Data Safety and Monitoring Board (DSMB) for the first 100 candidates selected to undergo the trials, the institute told IANS.
As a result, the further recruitment of the candidates for the trials has been put on hold. A total of 400 volunteers have registered for the trials, of whom 253 will be administered the first dose of the COVID vaccine.
“For the time being, the further recruitment of the candidates for the trials for the Oxford vaccine is on hold because we are waiting for the approval for safety of the first 100 participants recruited till now from the Data Safety and Monitoring Board. In this light, we would be able to update you regarding any development on this front by next weekend only,” said Prof. Dr Madhu Gupta, the principal investigator of the vaccine trial scheduled at the PGIMER.
Gupta had earlier informed that 16-member staff, including herself, would supervise the clinical trials.
Notably, PGIMER is among the 17 sites selected for the human clinical trials of the adenovirus-based Covid-19 vaccine candidate developed jointly by AstraZeneca and the University of Oxford.
Once developed, the production and marketing of the vaccine will be administered by the Serum Institute of India (SII) in Pune, one of the largest vaccine producers in the country.
Serum Insitute had earlier noted that the coronavirus vaccine may be developed by the end of this year given the progress made so far.
Meanwhile, the first COVID19 vaccine – Sputnik V – developed by Russia may be granted permission to release the first batch for civilians this week.