U.S. Health and Human Services Dept. Secretary Alex Azar told CNBC yesterday that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based company in collaboration with Oxford University.
Earlier this month, AstraZeneca voluntarily paused its trial after a standard review process was triggered so an independent committee could review safety data surrounding a single event of an unexplained illness that occurred in the UK Phase III trial for the AZD1222 vaccine candidate. The UK trial has since resumed, but the U.S. study remains paused.
“Look at the AstraZeneca program, Phase 3 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 [FDA] 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.”
AstraZeneca spokeswoman Michele Meixell confirmed to CNBC that the U.S. trial for the vaccine candidate has not yet resumed.
“Regulators in each individual country determine when trials can start and they do this in their own time frame,” Meixell said in a statement to CNBC. “On the current U.S. trial status specifically, we are continuing to work with the FDA to facilitate review of the information and the agency will decide when the U.S. trial can resume.”
AstraZeneca was one of nine companies whose CEOs signed a pledge earlier this month which vows to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first vaccines for the novel coronavirus, ensure safety with a potential vaccine candidate.
On Tuesday, The Washington Post reported that the FDA is expected to unveil a tougher new standard for an emergency use authorization (EUA) of a COVID-19 vaccine, possibly as soon as this week, that will make it more difficult for a vaccine candidate to garner regulatory clearance before Election Day (Nov. 3) — making it harder to accomplish something that President Trump has hinted could be done.
However, a report yesterday from Politico confirmed Trump’s stance that he may not give the go-ahead for the FDA’s revised guidelines, suggesting that the FDA’s decision is a “political move more than anything else.”
“That has to be approved by the White House,” Trump said. “We may or may not approve it.”
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease