As the COVID-19 pandemic is sweeping through the country taking India to the top three among the worst-hit nations after the U.S. and Brazil, the clinical trials for the Covid-19 vaccine by the University of Oxford have been deferred by at least a week.
Expected to begin in the first week of this month, the trials have been postponed as the approval of safety concerns is pending from the Data Safety and Monitoring Board (DSMB) for the first 100 candidates selected to undergo the trials. It was supposed to begin at The Post Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh. As a result, no further registration of future candidates for trials is being held for the time being.
“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,” said Prof. Dr. Madhu Gupta, the principal investigator of the vaccine trial scheduled at the PGIMER. “In this light, we would be able to update you regarding any development on this front by next weekend only,” she said. Gupta had earlier mentioned that a 16-member staff, including herself, would oversee the clinical trials.
The PGIMER said it received 400 volunteers for the trials. Of them, 253 would be administered the first dose of the vaccine developed jointly by AstraZeneca and the University of Oxford.
The PGIMER is chosen among the 17 sites selected for the human clinical trials of the adenovirus-based Covid-19 vaccine candidate. The institute will supposedly participate in the second and third phases of the proposed vaccine, the production, and marketing of which will be looked after by the Serum Institute of India (SII), one of the largest vaccine producers in the country. The Pune based firm’sCEO, Adar Poonawala, had earlier said that the coronavirus vaccine might be ready by the end of this year.