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NEW YORK: AstraZeneca has stopped a late-stage trial of one of the leading COVID-19 vaccine candidates after a suspected serious adverse reaction in a study participant, the news website reported Tuesday (September 8). Health Stat News.
He quoted an AstraZeneca spokesperson as saying in a statement that “the standard review process caused a pause in vaccination to allow review of safety data.”
The study is testing a COVID-19 vaccine being developed by researchers from AstraZeneca and the University of Oxford at various sites, including the UK, where the adverse event was reported.
The nature of the case and when it happened were not detailed, although the participant is expected to recover, according to Stat News.
The suspension of the trial has affected other AstraZeneca vaccine trials, as well as clinical trials being conducted by other vaccine manufacturers, looking for signs of similar reactions, Stat said.
The AstraZeneca spokesperson statement said that “in large trials, illnesses will happen by chance, but they need to be independently reviewed to verify this carefully.” Stat reported that serious adverse reactions vary and can include problems requiring hospitalization, life-threatening illness, and death.
AstraZeneca did not immediately respond to a request for comment.
Nine major vaccine developers from the US and Europe pledged Tuesday to uphold scientific standards of safety and efficacy for their experimental vaccines despite the urgency to contain the coronavirus pandemic.
The companies, including AstraZeneca, Pfizer Inc and GlaxoSmithKline, issued what they called a “historic compromise” after heightened concern that safety standards could fail in the face of political pressure to launch a vaccine.
The companies said they will “uphold the integrity of the scientific process as they work toward potential global regulatory filings and approvals of the first COVID-19 vaccines.”
The other signatories were Johnson & Johnson, Merck & Co, Moderna Inc, Novavax Inc, Sanofi and BioNTech.
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