Food and Drug Administration Commissioner Stephen Hahn said AstraZeneca and Oxford University’s Phase 3 COVID-19 vaccine trials in the United States remain pending after global trials were halted last week following the discovery of a serious disease in one of the The participants in the British experiment.
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Hahn told South Carolina Republican Sen. Tim Scott during an Instagram Live interview Tuesday that the FDA would conduct its own investigation into the case immediately to determine if the disease was linked to the lawsuit.
“We are here to protect the American public, and we will work very importantly with the company to find out if there is a significant security issue or not,”
Reuters, which first reported the news, was told by sources that enrollment of new patients and other procedures for the crucial US trial were rescheduled until at least mid-week and that it was not clear how long it would take for the FDA to complete its probe.
It is believed that the patient suffers from a rare spinal inflammatory disorder called transverse myelitis.
“We do not have all the facts, so we do not know the causal link per se, but we really need to investigate it,” Hahn added. “And that is our primary responsibility, the security of the American people.”
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A spokesman for AstraZeneca told FOX Business that the pharmaceutical company “continues to work with health authorities around the world, including the FDA in the United States, and be guided on when other clinical trials can be resumed to give the vaccine broad, fair and no profit below. this pandemic. “
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The announcement comes just days after Oxford University said it would resume the UK trial after regulators gave the go-ahead for an independent review process.
At least 18,000 people have so far received the vaccine globally in the UK, Brazil and South Africa
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The Associated Press contributed to this report