The FDA will let US trials of AstraZeneca and Oxford’s coronavirus vaccine RESUME weeks after it was paused over a rare ‘spinal problem’ in a UK participant.
According to documents obtained by the Wall Street Journal, US regulators have announced that AstraZeneca can resume the US arm of its trial of Oxford University’s coronavirus vaccine. AstraZeneca paused global trials on September 8 due to what it called at the time an ‘unexplained illness’ in a British volunteer.
Tests resumed on September 8 in the UK, but US Food and Drug Administration (FDA) officials decided to conduct their own independent investigation, finally agreeing to continuation of the trials on Wednesday.
Meanwhile, a participant in the Brazil arm of the trial died on Wednesday, but Oxford University determined that there was ‘no safety concern’ over the vaccine and related to the death and international trials are up and running again.
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