AstraZeneca Vaccine Trial Resumes In UK After Weeklong Pause
The company is working with health authorities to determine if a trial in the U.S. and in other places can resume, as well.
The Washington Post:
Coronavirus Vaccine Trial Resumes In U.K. After Week-Long Pause
A coronavirus vaccine trial resumed Saturday in the United Kingdom after the study was paused for a week because of an unexplained illness in a trial participant. The recommendation to resume human testing of the vaccine candidate being developed by the University of Oxford and pharmaceutical giant AstraZeneca was made by an independent safety review committee and by the U.K. health regulator. Authorities made no further information available about the nature of the participant’s illness, citing privacy protections. (Johnson, 9/12)
Stat:
AstraZeneca Resumes Covid-19 Vaccine Trials In The U.K.
The illness that triggered the international pause, which occurred in a woman who was in the vaccine arm of the U.K. trial, has not been officially disclosed, though AstraZeneca CEO Pascal Soriot told a group of investors on Wednesday that her symptoms were consistent with transverse myelitis, a serious condition involving inflammation of the spinal cord that can cause muscle weakness, paralysis, pain and bladder problems. ...It’s not uncommon for clinical trials to be paused. This is the second known hold of studies of the AstraZeneca vaccine. A woman in the U.K. trial was diagnosed with multiple sclerosis in July, but that event, which triggered the first pause, was deemed not to be related to the vaccine.(Branswell, 9/12)
AP:
Oxford And AstraZeneca Resume Coronavirus Vaccine Trial
British Health Secretary Matt Hancock welcomed the restart, saying in a tweet that it was “good news for everyone” that the trial is “back up and running.” The university said in large trials such as this “it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety.” (Pylas, 9/13)
In related news —
The New York Times:
Vaccine Makers Keep Safety Details Quiet, Alarming Scientists
The morning after the world learned that a closely watched clinical trial of a coronavirus vaccine had been halted last week over safety concerns, the company’s chief executive disclosed that a person given the vaccine had experienced serious neurological symptoms. But the remarks weren’t public. Instead, the chief executive, Pascal Soriot of AstraZeneca, spoke at a closed meeting organized by J.P. Morgan, the investment bank. (Thomas, 9/13)
Fox News:
WHO Scientist Calls AstraZeneca Coronavirus Trial Pause 'Good Wake-Up Call'
A top scientist at the World Health Organization (WHO) on Thursday said the pause in pharmaceutical company AstraZeneca’s coronavirus vaccine study is a “good wake up call,” given “ups and downs in research.” The company suspended its Phase III trial this week after a participant in the United Kingdom experienced a serious adverse reaction. Dr. Soumya Swaminathan, WHO chief scientist, on Thursday said clinical trial protocols have an operating procedure for managing any side effects among participants. (Rivas, 9/12)
Stat:
The Ethics Of Pausing A Vaccine Trial In The Midst Of A Pandemic
The revelation that AstraZeneca paused its clinical trials for a Covid-19 vaccine has focused attention on the company and the clinical trial process. The hold occurred after a participant in the trial developed symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis. To better understand the ethics of vaccine trials in the time of coronavirus, I talked with Ruth Faden, a Johns Hopkins bioethicist with a special interest in vaccine development. (Skerrett, 9/11)
