AstraZeneca late-stage trial of coronavirus vaccine is still on hold in the US, according to Health and Human Services Secretary Alex Azar.
He said that federal investigators are still looking for “answers to important questions” regarding the safety of patients.
“Look at the AstraZeneca program, phase three clinical trial, a lot of hope. Single serious adverse event report in the United Kingdom, global shutdown and hold of the clinical trials,” Azar said during his interview on CNBC’s “Squawk Box.”
“Still on hold here in the United States as the (U.S. Food and Drug Administration) seeks answers to important questions to verify safety information around those vaccines. Plan is by the book, we’re keeping patient safety at the center of everything we do,” he said.
AstraZeneca spokeswoman Michele Meixell confirmed that the AstraZeneca late-stage trial of coronavirus vaccine is still on hold.
“Regulators in each individual country determine when trials can start and they do this in their own time frame,” she told CNBC in a statement. “On the current U.S. trial status specifically, we are continuing to work with the FDA to facilitate review of the information and the agency will decide when the U.S. trial can resume.”
A standard precaution
Earlier this month, 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.
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.
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.