Pharmaceutical giant AstraZeneca Plc, has disclosed that the Covid-19 vaccine being developed by the company, in collaboration with the University of Oxford, could still be ready before the end of the year.
This is coming after the suspension of its final stage trial, over safety concerns, that involved a possible serious neurological problem in one of the participants.
The disclosure was made by the CEO, AstraZeneca Plc, Pascal Soriot, while speaking at an online conference on Thursday, September 10, 2020. He sought to reassure investors, after the drugmaker and its partner confirmed on Wednesday, that they had put a hold on giving experimental shots of the vaccine to people.
Although such interruptions are common in vaccine studies, the drugmaker and its partner are facing questions about what exactly happened, and whether it could be related to the shot.
He pointed out that an independent committee was drafted in to review safety, although the company said it was a routine action, designed to maintain the integrity of the trials.
Soriot, in his first public comment since they put the trials on hold, said, “What we have here is a special set of circumstances, where the whole world becomes involved in the conduct of a clinical trial. The decision on whether to resume the study, is in the hands of a group of independent experts, working to understand whether the patient’s illness was a coincidence or a result of the vaccine.’’
He added, “The reality is we all have to be very patient and see how it unfolds.”
Going further, Soriot said that it was still not clear whether the participant had a condition called transverse myelitis, a suspected diagnosis, just as he was not able to evaluate how long the trials would be put on hold.
Richard Hatchett, Coalition for Epidemic Preparedness Innovations (CEPI), said that this suspension shows the importance of rigorous final-stage trials, to pick up on potential side effects or rare events. It is also a compelling reason for having a diversified portfolio of Covid-19 vaccines under development, a strategy that CEPI is employing with its partners.
AstraZeneca is one of several drug companies taking part in the U.S. government’s Operation Warp Speed program, to accelerate the development of a coronavirus vaccine. It is also one of the 9 vaccine candidates around the world in the final stage of human trials.
