Company could restart COVID-19 vaccine trials next week


A report in the UK suggests AstraZeneca could restart dosing in the late-stage clinical trials of its COVID-19 vaccine next week, depending on the completion and outcome of the current investigation into a single adverse event.

Dosing in the trials of the vaccine the company is developing with The University of Oxford was paused in the past 48 hours after reports of a single adverse event.

The UK Financial Times has reported AstraZeneca CEO Pascal Soriot held a conference call with investors on Wednesday.

According to the report, Mr Soriot confirmed a UK trial participant "experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis."

He said the diagnosis is yet to be confirmed but that she is improving and is expected to be quickly discharged from the hospital. Mr Soriot also confirmed the participant was administered the investigative vaccine and not placebo.

The Financial Times said a previous study showed that 37 cases of transverse myelitis have been reported over 40 years after different vaccinations including against hepatitis B, measles-mumps-rubella and diphtheria-tetanus-pertussis.

It reported Stephen Evans, Professor of Pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, saying, “When large numbers of people are included in trials, coincidental events can occur and when they are unexpected, then an investigation is required to see if they are just coincidence or a result of the vaccine.”

"People associated with the trial said it could resume early next week, after the study’s independent data monitoring board has investigated," added the report.

However, it also said some analysts believe the company could be forced to scrap development of the vaccine if a link is found between its administration and the adverse event.

Mr Soriot is also reported to have said it is the second time the trials have been halted. The first time was in July when another participant experienced neurological symptoms that were subsequently diagnosed as multiple sclerosis and unrelated to the vaccine.

Health minister Greg Hunt told ABC Radio Melbourne late yesterday AstraZeneca had told him that, pending a full investigation of the adverse event and the recommencement of the trials, the situation was unlikely to result in a delay in the development of the vaccine.