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AstraZeneca Denies Vaccine Trial Subject Had Nerve Ailment

Bloomberg logoBloomberg 9/17/2020 James Paton and Robert Langreth
a sign in front of a building: The AstraZeneca Plc logo sits on an building at the company's facilities in Sodertalje, Sweden, on Thursday, April 11, 2019. AstraZeneca raised its annual sales forecast, helped by demand for the U.K. drugmaker's roster of new cancer drugs. © Bloomberg The AstraZeneca Plc logo sits on an building at the company's facilities in Sodertalje, Sweden, on Thursday, April 11, 2019. AstraZeneca raised its annual sales forecast, helped by demand for the U.K. drugmaker's roster of new cancer drugs.

(Bloomberg) -- AstraZeneca Plc, the drugmaker working with the University of Oxford on a Covid-19 vaccine, contradicted a report that a volunteer in U.K. tests of the shot developed a rare nerve disease that might have signaled severe safety problems.

AstraZeneca was responding Thursday to a CNN report citing documents indicating that the diagnosis of the participant was confirmed as transverse myelitis. The diagnosis was “based on preliminary findings,” and is inaccurate, the Cambridge, England-based drugmaker said in an emailed statement.

Transverse myelitis has been linked to both vaccines and viral infections, and the Astra vaccine contains a virus that’s been altered to prevent it from growing in people. A diagnosis soon after vaccination raises the possibility that the virus used in the vaccine or some other component somehow triggered the rare reaction.

A CNN spokeswoman said the network stood by its story, which cites an initial report on the volunteer’s neurological condition.

It’s the first time AstraZeneca has specifically ruled out such a diagnosis. Chief Executive Officer Pascal Soriot has said it was unclear whether the trial participant had the condition. A document posted online by Oxford later said the person’s symptoms included limb weakness or “changed sensation” and were unlikely to be linked to the shot.

a sign in front of a building: The AstraZeneca Plc logo sits on an building at the company's facilities in Sodertalje, Sweden, on Thursday, April 11, 2019. AstraZeneca raised its annual sales forecast, helped by demand for the U.K. drugmaker's roster of new cancer drugs. © Bloomberg The AstraZeneca Plc logo sits on an building at the company's facilities in Sodertalje, Sweden, on Thursday, April 11, 2019. AstraZeneca raised its annual sales forecast, helped by demand for the U.K. drugmaker's roster of new cancer drugs.

“We are unable to comment further on this individual case because of international norms governing the integrity of clinical trials and protection for the privacy of individuals,” the company said Thursday.

Astra’s U.S.-traded depositary receipts rose 1.3% in New York.

Timeline Clouded

Questions continue to surround the participant’s illness, which has sparked concerns about vaccine safety and increased worries about when the first shots against the coronavirus could be ready. President Donald Trump said Wednesday that Covid-19 vaccines may be widely available as early as October, running counter to administration officials and companies whose estimates of the timelines are months longer.

Trials of the Oxford-Astra vaccine resumed in the U.K. over the weekend, after a pause to investigate the adverse event, while researchers in South Africa also restarted tests. But a big U.S. trial of the vaccine is still on hold. AstraZeneca is talking with the U.S. Food and Drug Administration, which is reviewing information related to the episode and will decide when the U.S. trial of the vaccine can resume, according to the statement.

(Updates with CNN comment in fourth paragraph.)

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