Food and Drug Administration Commissioner Stephen Hahn said the trial of the Phase 3 COVID-19 vaccine from AstraZeneca and Oxford University was halted following a global trial last week after one of the UK trial participants discovered a serious illness.
The FDA’s Bill Gates’s eligibility limits have empowered agencies to carry out this policy.
Hahn told South Carolina Republican Sen. Tim Tim on Tuesday during an Instagram live interview that the FDA would investigate the matter immediately to test the disease.
“We are here to protect the American public and we are going to do very important work with the company to find out if there is a significant safety issue or not,” Hahan said.
Reuters, reporting the news, was quoted by sources as saying that US testing for enrollment of new patients and other critical procedures was being rescheduled to at least midweek, and it was unclear whether the FDA was expected to complete its investigation How much time will it take? .
The patient is believed to have a rare spinal inflammatory disease called transverse myelitis.
“We don’t have all the facts, so we don’t know the reason for it, but we really need to look into it,” said Hahan. And this 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 would “continue to work with health authorities around the world, including the FDA in the US, and be directed when other clinical trials provide the vaccine roughly and equitably Can resume for. ” No benefit during this epidemic. “
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Oxford University said the announcement would come only days after Britain resumed the trial, as regulators allowed it to proceed after an independent review process.
At least 18,000 people have received the vaccine so far in Britain, Brazil and South Africa
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The Associated Press contributed to this report