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UPDATE 2-Oxford coronavirus vaccine data could go to regulators this year

Tue, 25th Aug 2020 08:23

* Director says must have data for emergency approval

* Around 50,000 people in late stage clinical trials

* Oxford is a leading candidate in vaccine race
(Recasts, adds quotes, detail)

By Alistair Smout and Sarah Young

LONDON, Aug 25 (Reuters) - Trial data for the University of
Oxford and AstraZeneca's possible coronavirus vaccine could be
given to regulators this year but corners cannot be cut to speed
up approval for emergency use, a scientist leading the trials
said on Tuesday.

The Oxford vaccine produced an immune response in its first
human trials, underlining its position as one of the leading
candidates in the race to combat a virus that has led to
hundreds of thousands of deaths and crippled the global economy.

"It is just possible that if the cases accrue rapidly in the
clinical trials, that we could have that data before regulators
this year," Andrew Pollard, director of the Oxford Vaccine
Group, told BBC Radio of progress in larger, late-stage trials.

"Then there would be a process that they go through in order
to make a full assessment of the data."

The trials hit the headlines earlier this week when the
Financial Times reported the Trump administration was
considering fast-tracking the vaccine for use in the United
States ahead of the Nov. 3 presidential election.

One option being explored would involve the U.S. Food and
Drug Administration (FDA) awarding "emergency use authorization"
in October to the potential vaccine, the newspaper said.

Pollard said the process for emergency use authorisation was
well established. "But it still involves having carefully
conducted data ... and evidence that it actually works," he
said.

The Financial Times reported that Washington was considering
basing emergency approval of the vaccine on just a small UK
study of around 10,000 people.

Pollard, the chief investigator of the global clinical
trials of the vaccine candidate, said AstraZeneca would
take the data to regulators once the scientists were satisfied
with it.

He said Oxford had enrolled about 20,000 people in trials
across Britain, Brazil and South Africa, with AstraZeneca
leading a U.S. trial of 30,000 people.

"The size of the trials still isn't the issue here, what you
need is to have enough cases accruing during the time of
observation in the trials," Pollard said.

(Additional reporting by Marc Jones; editing by Kate Holton and
Mark Potter)

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