The BrihanMumbai Municipal Corporation (BMC) is likely to postpone the Phase 2 and Phase 3 clinical trials of COVIDSHIELD, the Oxford vaccine and AstraZeneca for COVID-19, after one of the participants in the United Kingdom had an adverse effect. Civic officials said the hospital administration of the King Edward Memorial (KEM) hospital has decided to hold trials till further clarification. A doctor, who is part of the trials, said some of the volunteers are thinking of backing off.
The Indian Council of Medical Research (ICMR) has selected two civic-run hospitals— the KEM hospital and BYL Nair Hospital to run the Oxford vaccine AZD1222 in India, which is also known as COVISHIELD. On Monday, KEM hospital received a green signal to start the trials, but now they have paused.
Dr Hemamy Deshmukh, dean, KEM hospital said they will not start the clinical trials until they get further clarification. Meanwhile, they will be administering the volunteers who have registered themselves for these trials. “It is kind of a casualty effect, which means we need to find out if the side effects are caused due to vaccines or some other reasons. It can also be said of sudden unexpected suspected adverse reactions (SUSAR), which need to be monitored closely before starting the trials,” he explained.
Dr Deshmukh added that the volunteer has fallen sick due to a potential adverse reaction after the dose. “As reported, the patient had a neurological issue, which led to the complications. So, we will wait till the sky gets clear.”
Over 150 volunteers have registered with the KEM hospital for the clinical trials. “However, till Wednesday afternoon, we received over 40 calls inquiring about the adverse effect on volunteers. The volunteers are covered under insurance,” said a senior doctor.
Dr Trupti Gilada, infectious disease specialist, Masina Hospital said such temporary holds are common in large clinical trials. “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 is even more important in vaccines, because it is given to healthy individuals and the most important thing is to ‘first, do no harm’,” she said. Dr Gilada said that the companies are following all the ethical standards. “Hopefully, the clinical trial will resume in all its sites, including Mumbai, once they receive clearance from this investigation process.”
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 partnered together to manufacture the experimental COVID-19 vaccine candidate formulated at the University of Oxford. Despite repeated calls, Adar Poonawalla, CEO of Serum Institute, was unavailable for comment. The institute released a statement, “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."