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

13:21  24 september  2020
13:21  24 september  2020 Source:   bloomberg.com

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Drug giant AstraZeneca said Tuesday it had paused global trials of its coronavirus vaccine because of an unexplained illness in one of the volunteers. National Institutes of Health director Dr. Francis Collins told a Senate hearing Wednesday that it 's a standard precaution in vaccine trials meant to

Soriot also confirmed that the clinical trial was halted once previously in July after a participant The new disclosures made by Soriot were heard by three investors participating on the call and were AstraZeneca only began its Phase 3 trial in the U.S. in late August. The U.S. trial is currently taking

(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.

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AstraZeneca said on Saturday that it had signed contracts with France, Germany, Italy and the Netherlands to supply the European Union with up to 400 million doses of the potential vaccine. We are manufacturing in parallel. We will be ready to deliver from October if all goes well," Soriot said .

Scientists demand clarity as boss of pharma giant making the jab says they are ' waiting ' on the FDA AstraZeneca stopped global trials on September 8 to investigate a side effect Scientists report a lack of communication from AstraZeneca to US health chiefs And we are waiting to hear their decision.' The FDA , the main drug regulator and American

“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.

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.

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The company said that its vaccine is among those selected to be part of the US government's Operation FDA commissioner: US 'on target' to have vaccine by year's end or early next year. The pharmaceutical company AstraZeneca announced in May that it received more than billion from

Mihaescu further explained that the EMA considers RBM in clinical trials to be an effective tool for addressing areas of risk, whether high or low, early in and throughout the drug development process and thus allow the sponsor to be better positioned when seeking to submit an application and bring a

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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