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AstraZeneca Is Waiting to Hear From FDA on Trial Halt, CEO Says

Bloomberg logo Bloomberg 9/24/2020 James Paton

(Bloomberg) -- AstraZeneca Plc, the drugmaker developing a potential coronavirus vaccine with the University of Oxford, said it is still waiting for a decision from U.S. regulators on whether it can resume tests in the country after halting global trials due to concerns about a participant who became ill.

The company also is considering providing more information about clinical trials amid calls for increased transparency, Chief Executive Officer Pascal Soriot said Thursday in a World Economic Forum meeting.

“The question is how much transparency can you provide?” Soriot said in the online session. “We’re discussing with other companies, as an industry, what kind of transparency could we offer without compromising patient privacy, but also without compromising the trial itself.”

Although such temporary halts aren’t uncommon in clinical tests, the event has raised concern about when the first products could be ready as another wave of infections hits Europe. Governments are pushing for vaccines to combat the coronavirus as the death toll approaches 1 million worldwide.

AstraZeneca sent information to the U.S. Food and Drug Administration, “and we’re waiting to hear their decision,” Soriot said.

Video: Trump may block stricter FDA guidelines for vaccine (Reuters)


Questions continue to surround the illness of the vaccine volunteer in the U.K. trial and the safety data that triggered the pause. The interruption of the project -- one of the front-runners in the quest to find a Covid-19 shot -- has highlighted the hurdles and uncertainties researchers face on the road to developing a vaccine.

Trials of the Oxford-Astra vaccine have resumed outside the U.S. in locations including the U.K. and South Africa.

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