AstraZeneca says no confirmed diagnosis yet for vaccine trial incident

AstraZeneca says no confirmed diagnosis yet for vaccine trial incident
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AstraZeneca on Wednesday said an independent committee is investigating the safety of its coronavirus vaccine trial but denied there was definitive evidence that a patient contracted a case of spinal inflammation.

The company's CEO, Pascal Soriot, reportedly told investors during a private call on Wednesday that a volunteer experienced neurological symptoms consistent with transverse myelitis, a rare but serious spinal inflammatory disorder.

A spokesperson for AstraZeneca said Soriot did not have a definitive diagnosis of the patient.

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"Reports claiming to be based on comments made earlier today by our CEO stating that we have confirmed that a participant in our clinical trial suffered from transverse myelitis are incorrect. He stated that there is no final diagnosis and that there will not be one until more tests are carried out. Those tests will be delivered to an independent safety committee that will review the event and establish a final diagnosis," the spokesperson said in a statement to The Hill. 

According to Stat, which first reported on the call, Soriot told investors the patient's diagnosis had not been confirmed but that she is improving and was expected to be released from the hospital as early as Wednesday.

The company also confirmed publicly for the first time that the trial was previously halted in July for another safety review.  

In that instance, a patient experiencing neurological symptoms was confirmed to have an undiagnosed case of multiple sclerosis that was unrelated to the vaccine treatment. 

AstraZeneca announced late Tuesday that it was pausing its clinical trial of a COVID-19 vaccine because of a “potentially unexplained illness.”

The company on Wednesday said an independent committee will review the safety data, but it was not yet clear how long the pause will last.

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The decision to pause the trial was met with applause from the public health community. 

Francis Collins, the director of the National Institutes of Health, told a Senate panel the decision was "not at all unprecedented" and shows the scientific process is being followed rigorously.

The decision "is a concrete example of how even a single case of an unexpected illness is sufficient to require a clinical hold for the trial in multiple counties," Collins told members of the Senate Health, Education, Labor and Pensions Committee.

"This ought to be reassuring," Collins added. "When we say we are going to focus first on safety and make no compromises, here is Exhibit A of how that is happening in practice."

AstraZeneca is one of three companies that have phase three coronavirus vaccine trials ongoing in the United States. Two other trials are being conducted for potential vaccines from Pfizer and Moderna.

Collins said he was not concerned that the pause might mean a delay in a possible vaccine, as the U.S. is investing in multiple candidates.

"The reason we’re investing not in one but in six different vaccines is because of the expectation that they won’t all work," Collins said.