(Adds background on the trial, quote from Hahn)
Sept 15 (Reuters) - The top U.S. Food and Drug
Administration official on Tuesday confirmed AstraZeneca Plc's
U.S. COVID-19 vaccine trial is on hold, saying the
agency is planning to do "very significant work" with the
company as it conducts its investigation after an illness in a
participant in Britain.
"We're here to protect the American public and we're going
to do very significant work with the company to figure out if
there's a significant safety issue or not," FDA Commissioner
Stephen Hahn said during an Instagram Live interview with
Republican U.S. Senator Tim Scott of South Carolina.
"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.
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 participant in its
U.K. trial had a serious side effect thought to be a rare spinal
inflammatory disorder called transverse myelitis.
The U.K. trial has resumed, as have the company's trials in
Brazil and South Africa.
Reuters on Monday reported based on sources that the U.S.
trial was still on hold pending FDA and safety panel
investigations.
The U.S. government process for reviewing COVID-19 vaccine
efforts is being closely watched as some scientists and public
health officials fear President Donald Trump will rush to have a
vaccine approved before the Nov. 3 presidential election to
bolster perception of his handling of the pandemic.
(Reporting by Manojna Maddipatla in Bengaluru, writing by
Caroline Humer; Editing by Arun Koyyur and Cynthia Osterman)
Astrazeneca (AZN)
