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AstraZeneca puts leading COVID-19 vaccine trial on hold over safety concern

CoronavirusSep 08, 2020 11:40PM ET
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© Reuters. FILE PHOTO: The company logo for pharmaceutical company AstraZeneca is displayed on a screen on the floor at the NYSE in New York

By Deena Beasley

(Reuters) - AstraZeneca (NYSE:AZN) Plc on Tuesday said it has paused global trials, including large late-stage trials, of its experimental coronavirus vaccine because of an unexplained illness in a study participant.

The vaccine, developed with the University of Oxford, has been widely seen as one of the leading global candidates against the coronavirus, and the suspension of the trial dims prospects for a potential year-end rollout its lead developer had signaled earlier.

AstraZeneca said it voluntarily paused trials to allow review of safety data by an independent committee and was working to expedite the review of the single event to minimize any potential impact on the trial timeline.

"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials," the company said in an emailed statement.

The nature of the illness and when it happened were not detailed, although the participant is expected to recover, according to Stat News, which first reported the suspension due to a "suspected serious adverse reaction".

The U.S. Food and Drug Administration defines an adverse event as one in which evidence suggests a possible relationship to the drug being tested.

According to a New York Times report which cited a person familiar with the situation, 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.

Whether the illness was directly linked to AstraZeneca's vaccine remains unclear, the report said. AstraZeneca declined to comment on the report.

The suspension of the trial has impacted other AstraZeneca vaccine trials - as well as clinical trials being conducted by other vaccine makers, which are looking for signs of similar reactions, Stat said.

The U.S. National Institutes of Health, which is providing funding for AstraZeneca's trial, declined to comment.

AstraZeneca's statement said that "in large trials, illnesses will happen by chance but must be independently reviewed to check this carefully."

Trials of the vaccine, called AZD1222, are underway at different stages in Britain, the United States, Brazil, South Africa and India. Trials are also planned in Japan and Russia.

Shares of AstraZeneca fell more than 8% in after-hours U.S. trading, while shares of rival vaccine developers rose. Moderna (NASDAQ:MRNA) Inc was up more than 4% and Pfizer Inc (NYSE:PFE) climbed less than 1%.

Moderna said in an emailed statement it was "not aware of any impact" to its ongoing COVID-19 vaccine study at this time.

Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold scientific safety and efficacy standards for their experimental vaccines despite the urgency to contain the coronavirus pandemic.

The companies, including AstraZeneca, Moderna and Pfizer, issued what they called a "historic pledge" after a rise in concern that safety standards might slip in the face of political pressure to rush out a vaccine.

The companies said they would "uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines."

The other signatories were Johnson & Johnson, Merck & Co, GlaxoSmithKline (NYSE:GSK), Novavax (NASDAQ:NVAX) Inc, Sanofi (NASDAQ:SNY) and BioNTech.

AstraZeneca puts leading COVID-19 vaccine trial on hold over safety concern
 

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Comments (7)
Carsten Sørensen
Carsten Sørensen Sep 09, 2020 2:59AM ET
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Only thing good about this, are med having stocks in Pfizer giving them a better chance in the lead
Kaveh Sun
Kaveh Sun Sep 09, 2020 2:49AM ET
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In a few rare cases, a flu vaccine can damage the nervous system like muscle weakness, numbness, difficulty walking or an odd gait, and even paralysis. But if u have a flu, u get 1k worst, even dealth.
Kaveh Sun
Kaveh Sun Sep 09, 2020 2:30AM ET
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It could b the immune response attacking and damaging the spinal cord.
Kaveh Sun
Kaveh Sun Sep 09, 2020 2:08AM ET
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Even dead viruses injectec in bodies, a few have this reaction. These vaccines use a “weaken” version of the live virus.
Plopseven Schwartz
Plopseven Schwartz Sep 08, 2020 11:30PM ET
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Good thing Trump kneecapped the FDA for political reasons. Can’t wait for them to approve a dangerous vaccine soon.
Clinton Ronnenberg
Clinton Ronnenberg Sep 08, 2020 10:50PM ET
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No way I’m taking an mRNA or DNA vaccine anyway. Wait for a traditional inactivated vaccine some time in 2021.
Kaveh Sun
Kaveh Sun Sep 08, 2020 10:50PM ET
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Even dead virus can trigger ur body reaction badly. Swine flu vaccines uses dead viruses. 30mil eu took it: 5% adverse events, 47 were fatal.
Larry Glickman
Larry Glickman Sep 08, 2020 9:20PM ET
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Every medicine including aspirin can and does start a reaction for certain people. With this pandemic ******millions of people stopping trails that have already had good results to go for perfection will certainly lead the death of others who are late in getting the vacine. The Oxford AZN vacine has already passed strong tests with many patients.
 
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