“In the ongoing global randomized controlled trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily suspended vaccination to allow for review of safety data by an independent committee. An AstraZeneca spokesperson said. “This is a routine action that should occur whenever there is a potentially unexplained disease in any of the trials, while it is under investigation, ensuring that we maintain integrity of testing. “AstraZeneca did not provide details on what type of reaction the participant may have experienced or when the trial resumed. The spokesperson said they are speeding up the review in the hope that this will not cause drastic delays.
Dr Mohamed Slaoui, the chief advisor of, told CBS News that the UK’s Trial Data Safety Oversight Board “conducts a thorough review of the company’s vaccine candidate, standard procedure when an adverse event occurs in clinical trials.” .
Dr Jeff Pothoff, director of quality at the University of Wisconsin Health, where one of the trials is underway, received the potential vaccine on Wednesday, reports CBS affiliate WISC-TV. He noted that it is not unusual for testing to be suspended.
“We don’t know much more at the moment. All of these groups – AstraZeneca, Pfizer and Moderna – have incredible attention to safety, so if there’s a whisper or bit of something that might have gone wrong, or sometimes it’s just related to regulatory matters, ” Pothoff said. “There is so much paperwork, and the i’s are dotted and crossed that they would temporarily stop the trial while they find out something.” ”
The University of Oxford vaccination team confirmed in a statement to CBS News that this was the second time that trials were forced to stop due to a potential side effect. Earlier this summer, another participant showed unexplained symptoms, triggering the same mandatory stop.
“The result of this review diagnosed the individual with a disease deemed unrelated to the vaccine,” Oxford said, and the trial quickly resumed.
BBC News reported that the UK’s independent medical regulator, MHRA, may once again allow trials to resume in just a few days, if the participant’s illness is diagnosed and found to be unrelated to the canadidate vaccine.
The Oxford / AstraZeneca vaccine is considered the prime candidate in the race to develop an effective COVID-19 vaccine. The University of Oxford wastrials in UK, Brazil and South Africa. In , there was no evidence that the drug caused serious reactions.
Other candidate vaccines in phase three trials are under development by Pfizer / BioNtech and Moderna. Russia has skipped phase three testing for its potential vaccine. On Tuesday, the CEOs of nine drug makers – AstraZeneca, BioNTech,, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi – issued a joint statement pledging not to release a vaccine unless its safety is proven by rigorous testing.
President Trump has said a vaccine could be ready as early as November, but his own health experts say the timing is highly unlikely.