The second and third phase trials of the Oxford-AstraZeneca Covid-19 vaccine (COVISHIELD) are likely to get underway at the King Edward Memorial (KEM) and BYL Nair Hospitals by the end of this month. The Indian Council of Medical and Research (ICMR) had already granted its approval for the trials on August 7, but the civic hospital authorities are awaiting for a go-ahead from the state ethical committee.
Additional Municipal Commissioner Suresh Kakani said it was a proud moment for the corporation, as KEM and Nair, Covid hospitals, have been selected for the vaccine trials. 320 volunteers between the ages of 20 and 50 years will be selected and trials will begin by August-end. “Currently, we are looking for healthy volunteers who have not contracted SARS-CoV-2 virus and these candidates will be from all strata of society. We will be obtain volunteers' consent before conducting trials on them. These individuals need to be healthy, with no severe pre-medical conditions. They should not be on any medication or undergoing other lifetime treatment,” he said.
KEM Dean Dr Hemant Deshmukh said all those selected would have to undergo a rapid-antigen Covid test. The volunteers will also be examined for Covid-19 antibodies, which will indicate if they were ever exposed to the infection in the past and had recovered.
The Pune-based Serum Institute of India (SII) and the British-Swedish pharmaceutical giant AstraZeneca have partnered to manufacture the experimental Covid-19 vaccine candidate formulated at the University of Oxford.
“The clinical trial of Phase 1 was completed last month in the UK, which received a good response. This will be a trial of Phases 2 and 3. After the completion of Phase 2 trial, reports will be submitted to the info Safety Monitoring Board, then to the Central Drugs Standard Control Organisation, for Stage 3 of the trial,” said Dr Deshmukh.
In the earlier trials, volunteers who were injected with two doses of the vaccine provided a robust immune reaction. The vaccine candidate provoked a T-cell (white blood cells which will attack cells infected with the coronavirus) response within 14 days of vaccination and an antibody response within 28 days. The study was published in the science journal Lancet.