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U.S. FDA investigating AstraZeneca's COVID-19 vaccine candidate

Published 09/15/2020, 03:03 PM
Updated 09/15/2020, 03:05 PM
© Reuters. A test tube labelled with the Vaccine is seen in front of AstraZeneca logo in this illustration taken

(Reuters) - The U.S. Food and Drug Administration said on Tuesday AstraZeneca (NYSE:AZN) Plc's COVID-19 vaccine trial in the United States is still on hold, and it was working with the company to figure out if there was a significant safety issue or not.

"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," Commissioner Stephen Hahn said in an Instagram live session with Senator Tim Scott.

Reuters had on Monday reported based on sources the U.S. trial was still on hold, pending FDA and safety panel investigations.

Enrollment in the British drugmaker's global trials of the vaccine, which it is developing with researchers at Oxford University, was paused on Sept. 6, after a safety event was reported in its UK trial.

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