Oxford COVID-19 vaccine Phase 3 clinical trials put on hold
The COVID-19 vaccine trial conducted by Oxford University and AstraZeneca has been paused, according to a report from Stat News. One participant has fallen ill with an as-yet-unknown illness, and a review board will now investigate whether it’s an adverse reaction to the vaccine.
Known as AZD1222 (or ChAdOx1 nCoV-19), the drug has just begun Phase 3 clinical trials throughout the US. But these have now been put on hold in response to what may be a serious adverse reaction in a participant in a UK trial. Exactly what the reaction is and when it occurred has not yet been made public, but the report does note that the patient is expected to recover.
A spokesperson for AstraZeneca told Stat News that the company’s “standard review process triggered a pause to vaccination to allow review of safety data… [A pause is] a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”
The Oxford researchers have previously said that we could know before the end of 2020 whether AZD1222 is an effective vaccine against the coronavirus. It’s unknown what effect this pause may have on the timeline.
While this news sounds like a disappointing setback, it’s important to note that such pauses are somewhat common occurrences in clinical trials. It doesn’t mean the vaccine is “off,” either – the illness might not have been caused by the vaccine itself, and the point of the pause is to investigate that possible link.
“In large trials illnesses will happen by chance but must be independently reviewed to check this carefully,” the spokesperson told Stat News. Another insider reported that researchers are now looking into the data from other trials for cases of similar adverse reactions.
AZD1222 is just one of several vaccine candidates currently in clinical trials.
Source: Stat News