Baltimore Sun

AstraZenec­a pauses late-stage vaccine test after illness in UK

- By Lauran Neergaard

Late-stage studies of AstraZenec­a’s COVID-19 vaccine candidate are on temporary hold while the company investigat­es whether a patient suffered a serious side effect or if the illness had nothing to do with the shot.

In a statement Tuesday, the company said its “standard review process triggered a pause to vaccinatio­n to allow review of safety data.”

AstraZenec­a didn’t reveal any informatio­n about the possible side effect except to call it “a potentiall­y unexplaine­d illness.”

The health news site STAT first reported the pause in testing, saying the possible side effect occurred in the United Kingdom.

An AstraZenec­a spokespers­on confirmed the pause in vaccinatio­ns covers studies in the U.S. and other countries.

Late last month, AstraZenec­a began recruiting 30,000 people in the U.S. for its largest study of the vaccine. It also is testing the vaccine, developed by Oxford University, in thousands of people in Britain, and in smaller studies in Brazil and South Africa.

Two other vaccines are in huge, final-stage tests in the

United States, one made by Moderna Inc. and the other by Pfizer and Germany’s BioNTech.

Those two vaccines work differentl­y t han AstraZenec­a’s, and the studies already have recruited about two-thirds of the needed volunteers.

Temporary holds of large medical studies aren’t unusual, and investigat­ing any serious or unexpected reaction is a mandatory part of safety testing.

AstraZenec­a pointed out that it’s possible the problem could be a coincidenc­e.

“We are working to expedite the review of the single event to minimize any potential impact on the trial timeline,” the company statement said.

Dr. Ashish Jha of Brown University said via Twitter that the significan­ce of the interrupti­on was unclear but that he was “still optimistic” that an effective vaccine will be found in the coming months.

“But optimism isn’t evidence,” he wrote. “Let’s let science drive this process.”

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PAUL ELLIS/GETTY-AFP

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