Oxford COVID vaccine trials delayed over safety protocols in ChandigarhSeptember 07, 2020 17:08
(Image source from: thefederal.com)
Oxford University’s human trials at The Post Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh have been delayed by at least a week.
The human trials of the Oxford and Astra Zeneca vaccine were expected to begin in Chandigarh in the first week of September but were delayed to the safety approval pending from the Data Safety and Monitoring Board (DSMB) for the first 100 candidates that were selected to undergo the trials.
As a result, the further recruiting of the candidates for the vaccine trials has been put on hold and the PGIMER is waiting for the approval for the safety of the first 100 volunteers recruited till now for the vaccine.
Dr. Madhu Gupta, the principal investigator of the vaccine trial scheduled at PGIMER said that the next update on the conduct of trials in the institute can only be confirmed in the next week.
The premier institute of Chandigarh said that it has received 400 volunteers for the human trials of the Oxford University’s vaccine and 253 members of them were selected for the first dose of the undertrial vaccine.
Dr. Madhu Gupta had earlier informed that she and 16 other members of the staff would supervise the vaccine trials to be held in Chandigarh.
The PGIMER is among the 17 sites in India that are selected for human trials of the adenovirus based COVID-19 vaccine developed by the University of Oxford and Astra Zeneca jointly.
The PGIMER institute will participate in the second and third human trials of the proposed vaccine. The vaccine’s marketing and production will be looked after by the Serum Insitute of India which is one of the largest vaccine producers in the country.
Serum Institute of India’s Chief Executive Officer, Adar Poonawalla said that the vaccine for coronavirus will be ready for the Indians by the end of this year.
Serum Institute of India has a partnership with the Astra Zeneca to manufacture the ChAdOx1 nCov-19 vaccine in India. Covishield, the official name for the Oxford-Astra Zeneca’s vaccine will be released for commercial use once the trials are successfully completed and the regulatory approvals are in place.
A total of 1600 candidates will receive the vaccine as a part of the human trials of Covishield and each participant will be administered two doses in a gap of four weeks. The first dose will be given on day 1 and the next dose will be given on the 29th day.
After the completion of the trials, the reports will be sent to the Data Safety Monitoring Board and then to the Central Drugs Standard Control Organization.
By Gayatri Yellayi