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(Adds quote attributed by Stat to AstraZeneca, details)
Sept 8 (Reuters) - AstraZeneca Plc has paused a
late-stage trial of one of the leading COVID-19 vaccine
candidates 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 various
sites, including the United Kingdom, 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 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 AstraZeneca spokesperson's statement said that "in large
trials, illnesses will happen by chance but must be
independently reviewed to check this carefully." Stat reported
that serious adverse reactions vary and can include issues that
require hospitalization, life-threatening illness and death.
AstraZeneca did not immediately respond to a request for
comment.
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 and Aurora Ellis)
