AstraZeneca Plc, the drug maker working with the University of Oxford on a Covid-19 vaccine, contradicted a report that a volunteer in UK testing of the injection developed a rare nerve disease that could have pointed to serious safety concerns. .
AstraZeneca responded to a CNN report on Thursday citing documents indicating the participant’s diagnosis was confirmed as transverse myelitis. The diagnosis was “based on preliminary findings” and is inaccurate, the Cambridge, England-based pharmacist said in an emailed statement.
Transverse myelitis has been linked to both vaccines and viral infections, and the Astra vaccine contains a virus that has been altered to prevent it from developing in people. A diagnosis shortly after vaccination raises the possibility that the virus used in the vaccine or some other component has somehow triggered the rare reaction.
A CNN spokeswoman said the network kept its story, which cites an initial report on the volunteer’s neurological condition.
It is the first time that AstraZeneca has specifically ruled out such a diagnosis. Executive Director Pascal Soriot has said it was unclear whether the trial participant had the disease. A document published online by Oxford later said the person’s symptoms included weakness in the limbs or “change in sensation” and were unlikely to be related to the vaccine.
“We are unable to comment further on this individual case due to international standards governing the integrity of clinical trials and the protection of individual privacy,” the company said Thursday.
Astra’s depository receipts traded in the US increased 1.3% in New York.
Cloudy timeline
Questions continue to surround the participant’s illness, prompting concerns about vaccine safety and increasing concern about when the first coronavirus vaccines might be ready. President Donald Trump said Wednesday that Covid-19 vaccines may be widely available starting in October, which works against administration officials and companies whose timeframe estimates are longer months.
Trials of the Oxford-Astra vaccine resumed in the UK over the weekend, after a hiatus to investigate the adverse event, while researchers in South Africa also restarted testing. But a large trial of the vaccine in the United States is still awaiting. AstraZeneca is in discussions with the US Food and Drug Administration, which is reviewing the information related to the episode and will decide when the vaccine trial can resume in the US, according to the statement.
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