Drugmaker AstraZeneca says it paused global trials of its coronavirus vaccine on Tuesday after a volunteer came down with a mysterious illness.
According to the company, trials of the so-called Oxford Vaccine – named because of its development with the UK’s Oxford University – will remain on hold until the company can review the proper safety data. The vaccine is in late stage, Phase 3 trials in the US.
Drugmaker and NIH say this is a routine part of the process:
According to National Institutes of Health Director Dr. Francis Collins, pausing the trial is a routine precaution for the rest of the participants and a single event like this is fairly normal.
"To have a clinical hold, as has been placed on AstraZeneca, as of yesterday, because of a single serious adverse event, is not at all unprecedented,” Collins stated at a Senate hearing Wednesday.
Decision comes after AstraZeneca joins pledge not to compromise safety:
The announcement of the paused trial came just hours after AstraZeneca joined 8 other companies in a pledge promising not to seek premature approval for any coronavirus vaccine.
In addition to committing to “high scientific and ethical standards regarding the conduct of clinical trials”, the pledge also states the agreed conditions for seeking emergency vaccine authorization and says that companies will “work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.”
“This ought to be reassuring,” said Collins. “When we say we are going to focus first on safety and make no compromises, here is Exhibit A of how that is happening in practice.”
Trump and Biden campaign argue about vaccine ahead of election:
The pledge from drugmakers was designed to abate growing fears that a vaccine will be rushed to market as a political tool, particularly as the Trump and Biden campaigns argue about the likelihood that such a vaccine will be ready before election day.
Most recently, the two campaigns reiterated their positions on Labor Day, with Biden saying: “If I could get a vaccine tomorrow, I'd do it. If it cost me the election, I'd do it.” However, he also emphasized the need to “listen to the scientists.”
Biden’s running mate Kamala Harris stated that she would not solely trust Trump’s word about the safety of any vaccine given to the public ahead of the election.
Trump responded to the comments by demanding an apology from Biden and Harris, and claiming that they were engaging in “reckless anti-vaccine rhetoric” that would hurt public perception of a forthcoming vaccine. He added that “the vaccine will be very safe and very effective, and it will be delivered very soon."