AstraZeneca COVID-19 trial suspended in US as FDA investigates critical illness of UK participant

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Food and Drug Administration Commissioner Stephen Hahn said trial of phase 3 COVID-19 vaccine from AstraZeneca and the University of Oxford in the United States remains on hold after global trials have been suspended last week following the discovery of a serious illness in one of the trial participants in the UK.

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Hahn told Republican South Carolina Senator Tim Scott in an Instagram Live interview on Tuesday that the FDA would immediately conduct its own investigation into the matter to determine whether the disease was related to the lawsuit.

“We are here to protect the American public and we are going to do a very important job with the company to determine if there is a significant safety issue or not,” Hahn said.

Reuters, which first reported the news, learned from sources that new patient recruitment and other procedures for the US pivotal trial were being postponed until at least mid-week and that it was not was not clear how long it would take the FDA to complete its investigation. .

The patient is believed to have a rare spinal inflammatory disorder called transverse myelitis.

“We don’t have all the facts, so we don’t know the root cause of this per se, but we really have to look into it,” Hahn added. “And that is our primary responsibility, the safety of the American people. ”

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A spokesperson for AstraZeneca told FOX Business that the pharmaceutical company “will continue to work with health authorities around the world, including the FDA in the United States, and will be guided as to when further clinical trials may be available. resume to provide the vaccine in a broad, equitable and no-profit manner during this pandemic. ”

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The announcement comes just days after the University of Oxford said it would resume the UK trial after regulators gave the green light following an independent review process.

At least 18,000 people have received the vaccine worldwide so far in Britain, Brazil and South Africa

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The Associated Press contributed to this report

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