AstraZeneca U.S. Vaccine Trial Starts After Delay, Hospital Says
(Bloomberg) -- AstraZeneca Plc has begun a large-scale human trial of its coronavirus vaccine in the U.S. following a brief delay, according to researchers from the University of Wisconsin School of Medicine and Public Health who are helping conduct the tests.
The university, one of the sites for the 30,000 person trial, plans to begin injecting healthy volunteers on Tuesday, according to William Hartman, a UW Health anesthesiologist and investigator on the trial. It plans to ramp up to injecting 50 people a day shortly after the Sept. 7 Labor Day holiday, he said in an interview.
AstraZeneca didn’t immediately respond to a request for comment.
The AstraZeneca shot, invented by researchers at the University of Oxford, is one of the farthest along of numerous Covid-19 vaccines in development. In addition to the U.S. trial, a final-stage test of the inoculation is underway in the U.K. and could yield preliminary results as soon as next month. Other companies that have Covid-19 vaccines in phase 3 trials include Moderna Inc. and Pfizer Inc.
An Aug. 27 article in the Palm Beach Post reported that the U.S. trial of AstraZeneca vaccine has been put on hold due to political pressure, perhaps because U.S. regulators planned to grant an emergency use authorization on the basis of the trial in Europe.
Hartman said he was told the hold was due to unspecified operational issues.
“There was a hold on enrollment. We don’t really know what the reason for that was. We were told it had nothing to do with safety and didn’t have anything to do with an EUA, it was just an operational issue,” Hartman said in a phone interview. “On Friday evening, they lifted that hold.”
An email shared with Bloomberg that Hartman received on Aug. 28 from AstraZeneca and contract research organization Iqvia Holdings Inc. stated the hold “was lifted and we have our first patient screened and randomized.”
Americans should understand that “there are no corners that have been cut,” said Hartman, in a phone interview. “We are going to proceed with the trial independent of any political pressure.”
©2020 Bloomberg L.P.