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 On Tuesday, AstraZeneca said it voluntarily paused trials, including
late-stage ones, to allow an independent committee to review safety
data, and it was working to expedite the review to minimise any
potential impact on the trial timeline.
The vaccine, which AstraZeneca is developing with the University of
Oxford, has been described by the World Health Organization (WHO) as
probably the world's leading candidate and the most advanced in
terms of development.
"It is obviously a challenge to this particular vaccine trial,"
Britain's Health Secretary Matt Hancock told Sky News, adding: "It's
not actually the first time this has happened to the Oxford
vaccine".
The trial's suspension triggered a 2% fall in AstraZeneca's shares
in London and a 12% drop in the stock price of its Indian unit,
AstraZeneca Pharma India Ltd. AstraZeneca shares, which have the
second biggest weighting in the FTSE 100 index, were down 0.3% at
0820 GMT.
It follows reports that the United States was aiming for a
fast-track approval before the November presidential election.
Asked whether the pause would set back the vaccine development
process, Britain's Hancock said: "Not necessarily, it depends on
what they find when they do the investigation."
The BBC reported that a final decision on restarting the trial will
be taken by the medical regulator the MHRA, which could take only
days.
"This is a routine action which has to happen whenever there is a
potentially unexplained illness in one of the trials," the
AstraZeneca said in an emailed statement.
The nature of the illness was not disclosed, 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.
A New York Times report citing a person familiar with the situation
said a participant based in Britain was found to have transverse
myelitis, an inflammatory syndrome that affects the spinal cord and
is often sparked by viral infections.
Whether this was directly linked to AstraZeneca's vaccine remains
unclear, the report said. AstraZeneca declined to comment.
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'HISTORIC PLEDGE'
Called AZD1222, the vaccine is in late-stage clinical trials in the
United States, Britain, Brazil and South Africa and additional
trials are planned in Japan and Russia. The trials aim to enrol up
to 50,000 participants globally.
South Korea said on Wednesday it would look into the suspension and
review its plan to participate in the manufacturing of the vaccine.
"It's not rare that clinical trials get suspended as various factors
interact," health ministry official Yoon Tae-ho told a briefing.
The decision to put the trial on hold has impacted 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.
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, Novavax Inc, Sanofi and BioNTech.
(Reporting by Guy Fauconbridge, Estelle Shirbon, Kate Kelland in
London, Deena Beasley; Additional reporting by Peter Henderson in
San Francisco, Rocky Swift in Tokyo, Sangmi Cha in Seoul and Miyoung
Kim in Singapore; Editing by Alexander Smith)
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