Oxford COVID-19 Vaccine Trial on Hold after ‘Unexplained Illness’
One of the vaccines currently being trialed against COVID-19 has had to be put on hold following what's believed to be an adverse reaction in one volunteer, Stat News reported.
The vaccine is being developed by Oxford University and AstraZeneca, and the illness of the volunteer has yet to be disclosed publicly.
A review board is now set to investigate what the issue is before the vaccine trials can commence once again.
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The vaccine, known as ZD1222, was in its Phase 3 trial stage both in the U.K. and in the U.S., and due to one of its U.K. participant's reaction to the drug, the entire trial has now been put on pause. Although the participant has suffered a strong reaction, reports have stated they will recover.
A spokesperson told Stat News that the team will be looking thoroughly into the issue as the "standard review process triggered a pause to vaccination to allow review of safety data."
The spokesperson continued by explaining that this is "a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials."
Here's $AZN's updated statement, making clear that the company *voluntarily* paused vaccination in its P3 trial. https://t.co/kmjVIHGY1T pic.twitter.com/twitF5EFES— Rebecca Robbins (@RebeccaDRobbins) September 9, 2020
It's still unknown just how long the pause will be, but safety is their first priority.
This setback may sound frustrating in the race against COVID-19; however, it isn't uncommon for vaccine trials to hit the pause button now and then. Presently, it's unknown whether the participant's reaction was due to the vaccine or if it was totally unrelated.
As Dr. Gregory Poland, an infectious diseases expert and director of the Mayo Clinic's Vaccine Research Group in Rochester, Minnesota, said to NBC News, "Generally, when these events occur, trials are paused, data collected, and an independent data monitoring and safety board reviews the details to make a determination whether to resume the trial or alter it in some way."
He continued, "Often these events are coincidental, but these precautions are necessary to ensure the safety of the trial participants."
UPDATE September 12, 12:55 PM EDT: Oxford resumes trials
In a statement acquired by Fox Business, Oxford University announced it was resuming its controversial COVID-19 vaccine trials across all of its U.K. clinical trial sites.
“The independent review process has concluded and following the recommendations of both the independent safety review committee and the U.K. regulator, the MHRA, the trials will recommence in the U.K.,” it said.
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