Mumbai: KEM hospital gets DCGI's nod to start COVID-19 vaccine trials

Doctors and staff of KEM hospital handle COVID-19 patients

Days after the Oxford vaccine trial was halted due to suspected adverse reactions reported in a participant, KEM hospital officials said that the Drug Controller General of India (DCGI) gave them a green signal to resume the trials on Wednesday. However, the hospital needs the final nod from the ethics committee, which will meet today, to start screening the candidates who have registered for the trial.

Trial delayed

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.

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The ethics committee headed by Dr Padma Menon of KEM hospital had earlier raised questions regarding the insurance amount for the participants of the trial and had written to the Indian Council of Medical Research regarding it.

Hospital Dean Dr Hemant Deshmukh said the participants would be entitled to two kinds of insurance in case of any side effects. "There is a group insurance of Rs 10 crore for 160 participants and for medical bills, they will be granted Rs 35 lakh each if they suffer from any adverse reaction of the vaccine," added Dr Deshmukh.

While Dr Deshmukh said that more than 350 participants had already registered at KEM, Nair hospital Dean Dr Ramesh Bharmal said more than 100 participants had registered with them.

Formalities left

"We received an approval from the ICMR four to five days back and are yet to complete some formalities. We have 100 participants and will start the screening process soon," 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.

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