Safety approvals have delayed the commencement of the Oxford COVID-19 vaccine at the Post Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh. PGIMER is one of 17 trial sites selected for the clinical trial of the adenovirus-based COVID-19 vaccine developed by both University of Oxford and AstraZeneca. The clinical trial was supposed to start in the first week of September, however they are apparently delayed due to a delay in approval associated with the Data Safety and Monitoring Board (DSMB) for the first 100 volunteers identified for inoculation, reports the PGIMER to IANS (the largest independent news service in India). This represents a costly hold up as apparently 400 volunteers have signed up and 253 would receive the first dose of AZD1222 (aka ChAdOx1 nCoV-19).
Principal Investigator Speaks
Professor Dr. Madhu Gupta leads the study for PGIMER in this critically important clinical trial, with global implications. She is heading a 16-member staff to conduct the pivotal trial at PGIMER. Dr. Gupta reported, “For the time being, the further recruitment of the candidates for the trials for the Oxford vaccine is on hold because we are awaiting for the approval for safety of the first 100 participants recruited until 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.” Dr. Gupta’s statement indicates that the trial is at least two weeks behind—a serious delay given the magnitude and severity of the situation, and of course the high costs of clinical trials.
Assuming Approval, Production in India
Assuming that the clinical trial evidences safety and sufficient efficacy, and hence approval, the actual production of the vaccine is led by possibly the world’s busiest vaccine manufacturer—Serum Institute of India (SII) in Pune.
Conceived of and planned in 1960 and initiated in 1962, Postgraduate Institute of Medical Education and Research (PGIMER) is a medical and research institution in Chandigarh, India. It combines educational, medical research and training facilities for its students. It is also the leading tertiary care hospital in the region and caters to patients from all over Punjab, J&K, Himachal, Pradesh, and Haryana. A sophisticated academic medical center, it has all the latest facilities including all specialties, super specialties and subspecialties.
What is a DSMB?
A data safety monitoring board (aka data monitoring committee) is an independent group of experts who monitor patient safety and treatment efficacy while a clinical trial is ongoing. They exist to protect patient safety. If adverse events of a particularly serious type occur in the experimental arm compared to the control arm, then the DSMB must consider termination of a trial.