AstraZeneca CEO Pascal Soriot said that the results of the clinical trials for their experimental coronavirus vaccine may come out before the year ends.
However, this is possible if AstraZeneca is allowed to resume trials that were stopped this week.
The drugmaker decided to pause the late-stage trials after an illness in a study subject in Britain was found. The patient was manifesting neurological symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.
The decision of AstraZeneca to halt the trials of its coronavirus vaccine following an unexplained illness in one of the participants is a standard precaution in vaccine trials made to ensure that experimental vaccines do not cause serious reactions among participants.
The AstraZeneca CEO said that suspending a trial is common, and the only difference is that the world was watching.
Soriot pointed out that the company did not know the diagnosis for the volunteer in the trial. There was no certainty if they had transverse myelitis and more tests were necessary.
He added the diagnosis would be sent to an independent safety committee and this would typically then tell the company whether trials can take place again.
In a statement, the drugmaker said: “As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow the review of safety data.”
AstraZeneca’s vaccine, dubbed the Oxford vaccine because it was developed in partnership with the University of Oxford, is being tested in various parts of the world, including the US, the UK, Latin America, Asia, Europe and Africa.
Routine action
The pharma firm said: “This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”
“In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully. We are working to expedite the review of the single event to minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials,” AstraZeneca explained.
While it is usually the Data and Safety Monitoring Board (DSMB) that monitors trials for adverse events and can order a pause or halt a trial, the firm did not specify who ordered the stoppage.
In vaccine trials, the most common side effects include fever, headache, soreness at the injection site, and muscle pain.
Last week, the British pharmaceutical firm became the third company to begin Phase 3 trials in the US. Along with the other two drugmakers currently doing Phase 3 trials, Moderna and Pfizer/BioNTec, AstraZeneca received funding from the federal government.
AstraZeneca stated that it is “recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus.”
