AstraZeneca vaccine: why are clinical trials resuming and how was the patient affected?
Clinical trials for the AstraZeneca and Oxford University coronavirus vaccine have resumed following confirmation by the Medicines Health Regulatory Authority that it was safe to do so.
British clinical trials for the AstraZeneca and Oxford University coronavirus vaccine have resumed following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so, the company said at the weekend.
The late-stage trials of the experimental vaccine, one of the most advanced in development, were suspended this week after an illness in a study subject in Britain.
Oxford University says trials of a coronavirus vaccine that it is developing with pharmaceutical company AstraZeneca will resume, days after being paused due to a reported side effect in a patient in the U.K. https://t.co/2W1Mu4753o— The Associated Press (@AP) September 12, 2020
"The standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators," AstraZeneca said.
"The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume."
The company said it could not disclose further medical information. "All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards."
The nature of the safety issue and when it happened were not immediately known, although the participant is expected to recover, according to Stat News with a subsequent report in the New York Times citing a person familiar with the situation maintaining that a participant based in the United Kingdom was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections.
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