KEM awaits nod from ethics committee to start phase 2 & 3 of vaccine trials
King Edward Memorial (KEM) Hospital has received the Oxford COVID-19 vaccine. However, phase 2 and 3 of the clinical trials of COVIDSHIELD will start after a week once the hospital receives a nod from the state ethics committee.
Dr Hemant Deshmukh, dean, KEM Hospital, said they have begun the preparation for the trials. So far, more than 150 healthy volunteers have been registered. "We have received the vaccines. We will be following the protocol of screening the volunteers. We will only vaccinate those volunteers if both RT-PCR and antigen tests reports are negative," he said.
As part of the process, each of the participants will be made to undergo an RT-PCR test to find out whether they had COVID-19 before. As part of the much-awaited trial, three doses would be given to each of the participants over a period of four months.
A week after the Oxford vaccine trial was halted due to suspected adverse reactions reported in a participant, the Drug Controller General of India (DCGI) has given a green signal to resume the trials. However, the hospital needs the final nod from the ethics committee to start screening the candidates who have registered for the trial.
While the BrihanMumbai Municipal Corporation (BMC) had planned to start the trial at KEM Hospital from September 11 onwards, it could not be done, as reports of a participant suffering from some complications emerged. However, civic officials said that they had received the approval from DCGI to start the process. "We have received the DCGI's approval and now we need the ethics committee's permission. If all goes well at the meeting, we can start the formal screening of candidates latest by September 19," said Suresh Kakani, additional municipal commissioner, BMC. Meanwhile, BYL Nair Hospital is yet to receive these vaccines.