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The clinical trials of the AstraZeneca Oxford COVID-19 vaccine, AZD1222, have been paused for a safety review as a result of an incident of an unexplained illness in a UK trial patient.
The clinical trials of the AstraZeneca Oxford COVID-19 vaccine, AZD1222, have been paused for a safety review as a result of an incident of an unexplained illness in a patient participating in the Phase III trial taking place in the United Kingdom.
In a statement, issued by AstraZeneca on Sept. 9, 2020, the company announced that the routine action has been taken so that an independent review of safety data can be performed, and the integrity of the trials is maintained. The cause of the single incident of illness is not yet known.
“At AstraZeneca we put science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts,” said Pascal Soriot, CEO of AstraZeneca, in the company statement. “We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably, and at no profit during this pandemic.”
The company stated that it is working to expedite the safety review so that any potential impact on the trial timeline is minimized.