FDA Commissioner Stephen Hahn confirmed that the US trial of AstraZeneca's COVID-19 vaccine trial is on hold, and that the agency is planning to do "very significant work" with the company as it conducts its investigation after a UK participant fell ill, as reported in Yahoo!News.
"We don't have all facts, so we don't know the causation per se of this, but we really need to look into it, and our prime responsibility is the safety of the American people," Hahn said.
He added "we're going to do very significant work with the company to figure out if there's a significant safety issue or not."
Enrollment in global trials of the vaccine, which AstraZeneca is developing with Oxford University, was paused on September 6, after a participant in its UK trial had a serious side effect thought to be transverse myelitis.
The UK trial has since resumed, as have the company's trials in Brazil and South Africa.
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