Coronavirus vaccine: AstraZeneca's trial illness may not be linked to COVID-19 vaccine, says Oxford University

The University of Oxford said on Wednesday that the unexplained illness observed in a volunteer of the last stage clinical trials may not have been related to its coronavirus vaccine, developed by the British-Swedish pharma giant AstraZeneca. The information was shared by Oxford University in a document related to participant information. For the unversed, human trials of the Oxford-AstraZeneca Plc’s COVID-19 vaccine were paused in the UK on September 6 (and subsequently in India as well), after a UK volunteer fell ill.

The trials were paused after reports of a participant of the UK trial developing adverse side-effects emerged. According to a report published in the New York Times, the ‘unexplained illness’ that cropped up during the illness was a rare spinal inflammatory disorder called transverse myelitis.

“In the current trial, we have undertaken safety reviews when volunteers in the trials of ChAdOx1 nCoV-19 developed unexplained neurological symptoms including changed sensation or limb weakness, and have paused the study while a safety review took place,” the University of Oxford had posted in the information sheet online.

The clinical trials were resumed after a brief halt in the UK, India, Brazil and South Africa after a review by the independent safety review committee and national regulators deemed it safe to commence the study and inoculate new participants. However, they are yet be resumed in the United States as NIH officials have maintained that they are “very concerned” about the adverse illness as per a report published in Reuters.

According to the document shared by the University of Oxford, safety reviews were conducted when volunteers in the trials for testing the vaccine candidate, called AZD1222 or ChAdOx1 nCoV-19, developed unexplained neurological symptoms, including changed sensation or limb weakness, and the study was paused while a safety review took place.

Furthermore, the information document for prospective volunteers also highlighted that with any new medicine or vaccine there is always a possibility of an unexpected side effect.

"After independent review, these illnesses were either considered unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine.”

“In each of these cases, after considering the information, the independent reviewers recommended that vaccinations should continue. Close monitoring of the affected individuals and other participants will be continued”, the document said.

The takeaway

Oxford and AstraZeneca are among the front-runners in the quest to develop a vaccine against the coronavirus. At the time of writing this, coronavirus cases around the globe have crossed the 30 million mark, while the pandemic has already resulted in 9,45,176 deaths.