Tribune News Service
Chandigarh, September 23
The PGI today resumed the ongoing Phase II trials of the Oxford Covid-19 vaccine — Covishield. The first dose is likely to be administered within two days, a source confirmed.
As reported earlier, 0.5 ml of the dose will be given to the candidates and it will be repeated after 28 days. The candidates will be kept under observation for two to four weeks.
Ten candidates were screened today, with nine of them fulfilling the eligibility prerequisites for the study, including the minimum age of 18, no underlying medical condition and no prior Covid-19 infection. Besides, family members of the candidates are also required to be Covid negative.
The recruitment of candidates was put on hold for a short while at the PGI as approval for the safety of the first 100 participants from the Data Safety and Monitoring Board (DSMB) was awaited. The trials were to begin by the first week of September after recruiting volunteers.
The Serum Institute of India (SII) and the ICMR have partnered for the clinical development of two global vaccine candidates. One among them is ChAdOx1-S, which is a non-replicating viral vector vaccine developed by the University of Oxford/AstraZeneca. This vaccine is undergoing Phase II/III bridging studies initiated by the ICMR at 17 clinical trial sites, including the PGI.
The premier institute is going to assess immunogenicity (formation of antibodies) along with the safety of the vaccine.