(RTTNews) – British drug giant AstraZeneca’s (AZN.L, AZN) late-stage coronavirus vaccine trial in the U.S. remains on hold as regulators need further data over its safety, Health and Human Services Secretary Alex Azar told CNBC on Wednesday.
On September 6, the company voluntarily paused all global trials following a potentially unexplained illness in a U.K. volunteer, to allow review of safety data by independent committees, and international regulators.
The potential vaccine, AZD1222, is being developed by the pharmaceutical giant in partnership with Oxford University, and its spin-out company, Vaccitech. It is in phase III development in the U.S., UK, Brazil, and South Africa with additional trials planned to start in Japan and Russia.
However, after an investigation, AstraZeneca resumed the trial in the U.K on September 12, but it is still not certain when the company will start its US trial again. AstraZeneca said the UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.
“Look at the AstraZeneca program, phase three clinical trial, a lot of hope. Single serious adverse event report in the United Kingdom, global shutdown and hold of the clinical trials,” Azar told CNBC’s “Squawk Box”.
“Still on hold here in the United States as the (U.S. Food and Drug Administration) seeks answers to important questions to verify safety information around those vaccines. Plan is by the book, we’re keeping patient safety at the center of everything we do,” he said.
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