The trials that were expected to commence in the first week of September have been delayed due to the safety approval pending from the Data Safety and Monitoring Board (DSMB) for the first 100 candidates selected to undergo the trials, the institute told IANS.

 

In result, the further recruitment of the candidates for the trials has been put on hold.

 

"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.

 

The premier institute said it received 400 volunteers for the trials. Of them, 253 would be administered the first dose of the undertrial vaccine.

 

Gupta had earlier informed that 16-member staff, including herself, would supervise the clinical trials.

 

The 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. India.

 

The institute will participate in the second and third phases of the proposed vaccine. The vaccine's production and marketing will be looked after by the Serum Institute of India (SII), one of the largest vaccine producers in the country.