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COVID vaccine trials put on hold at KEM Hospital

The King Edward Memorial (KEM) Hospital in Parel has decided not to commence trials for the Covid-19 vaccine, developed by AstraZeneca and Oxford University, as they have been put on hold after a participant had an “adverse event” in the United Kingdom (UK). KEM Hospital was expected to start the trials on September 11 after the Indian Council of Medical Research (ICMR) had selected two civic-run hospitals – BYL Nair being the other one – in Mumbai to conduct the trials.

“We have decided to halt the trials. Until the causality factor of the adverse event is identified, the safety of the vaccine can’t be guaranteed. The sponsor of the trial and the manufacturer will report this to the regulating authority and ethics committee. Once, they respond, we will start giving the vaccine,” said Dr Hemant Deshmukh, dean, KEM Hospital said. “It is not in my hand. It is up to the regulating authority to decide.”

Pune-based Serum Institute of India (SII), which is the world’s largest manufacturer of vaccines in terms of volume, and British-Swedish pharmaceutical giant AstraZeneca have partnered to manufacture the experimental Covid-19 vaccine candidate formulated at the University of Oxford. The Oxford-AstraZeneca vaccine has been named Covishield in India.

SII issued a statement, which said: “We can’t comment much on the UK trials, but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all.”

The vaccine is a viral-vector vaccine that harnesses a cold-causing ‘adenovirus’ (a group of common viruses). It has been modified in such a way that it can no longer replicate in cells, and it modifies the ‘spike’ protein in human cells that the novel coronavirus targets to infect people. “The volunteer has been diagnosed with Transverse Myelitis that causes inflammation of the spinal cord. But ‘adenovirus’ doesn’t cause that. So, there is a possibility that this would not happen in India. But it needs proper analysis as the trials are being conducted on healthy people.”

Meanwhile, KEM Hospital has received applications from more than 100 volunteers who want to be part of the pan-India clinical trials. The hospital authorities plan to conduct the requisite medical examination of the volunteers till the trails are on hold.

“Without wasting time, we will keep the volunteers ready for the trials,” said Deshmukh.

Doctors said some volunteers may back out after the reports of the UK participant come out, as the hospital is already getting inquiries regarding it. “We have received more than 40 calls till [Wednesday] afternoon inquiring about the adverse effect on volunteers. But such hiccups are common in clinical trials. Therefore, volunteers are covered by insurance,” said a doctor, on condition of anonymity.

Dr Trupti Gilada, infectious disease specialist, Masina Hospital, said, “Such temporary holds are not uncommon in large clinical trials of vaccines or drugs. This is a standard safety check in the process to investigate if any potentially unexplained serious event seen is owing to the vaccine or is a mere coincidence. In fact, this is the reason why large clinical trials are done on new vaccines or drugs to ensure safety in addition to its efficacy. This shouldn’t cause any apprehension.” – Hindustan Times

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