By Integrated Care Journal-
The Oxford University Covid-19 vaccine trial has been put on hold after an adverse reaction from a participant.
Pharmaceutical company AstraZeneca, which is developing the Covid-19 vaccine in collaboration with Oxford University and IRBM in Pomezia, Italy, announced on Tuesday that the trial has been paused due to an unexplained illness in one of its participants.
At the time of publication, The New York Times has reported that a participant in the UK has been diagnosed with transverse myelitis, a type of inflammation that affects the spinal cord. Transverse myelitis is associated with a wide range of viruses and bacterial infections, such as flu, herpes viruses, HIV, hepatitis, and TB. However, this has not been confirmed.
“As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow the review of safety data by an independent committee,” a spokesperson for AstraZeneca said.
AstraZeneca went on to state that this is a “routine action” which must happen whenever there is a potentially unexplained illness in one of the trials.
Pauses in clinical trials are not uncommon, and with a testing pool of 30,000 people, unexplained illnesses are somewhat likely to occur - but trials must still be placed on hold in order to ensure safety.
This does not mean that the trial is permanently halted, only that data gained from the current testing cycle must be investigated and acted upon in order to ensure that testing can resume safely and to discern if the unexplained illness was directly linked to the vaccine.
“It’s not the first time that this has happened to the Oxford vaccine, and it’s a standard process in clinical trials whenever they find something that they need to investigate," says Secretary of State for Health Matt Hancock.
The Health Secretary added that the announcement does not necessarily mean it would cause a set back in the attempt to find a Covid-19 vaccine, and that "it depends on what they find when they do the investigation."
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