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(Adds background, detail on trial subject)
Sept 8 (Reuters) - AstraZeneca Plc has put a hold on
the late-stage trial of its highly-anticipated COVID-19 vaccine
candidate after a suspected serious adverse reaction in a study
participant, health news website Stat News reported on Tuesday.
It quoted an AstraZeneca spokesperson as saying in a
statement that the "standard review process triggered a pause to
vaccination to allow review of safety data.”
The study is testing a COVID-19 vaccine being developed by
AstraZeneca and University of Oxford researchers at sites
including the United States and the United Kingdom, where the
adverse event was reported.
The nature of the safety issue and when it happened were
not immediately known, although the participant is expected to
recover, according to Stat News.
The report said suspension of the trial was having an impact
on other AstraZeneca vaccine trials - as well as on clinical
trials being conducted by other vaccine makers.
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, Pfizer Inc and
GlaxoSmithKline, 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, Moderna Inc, Novavax Inc, Sanofi
and BioNTech.
(Reporting By Peter Henderson
Editing by Bill Berkrot)
