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UPDATE 2-Britain first to approve AstraZeneca/Oxford COVID-19 vaccine

Wed, 30th Dec 2020 07:08

(Adds details)

By Alistair Smout

LONDON, Dec 30 (Reuters) - Britain on Wednesday became the
first country in the world to approve a coronavirus vaccine
developed by Oxford University and AstraZeneca as it
battles a major winter surge driven by a new, highly contagious
variant of the virus.

AstraZeneca said the authorisation was for a two dose
regime, and that the vaccine had been approved for use for
emergency supply. Britain has ordered 100 million doses of the
vaccine.

"The government has today accepted the recommendation from
the Medicines and Healthcare products Regulatory Agency (MHRA)
to authorise Oxford University/AstraZeneca’s COVID-19 vaccine
for use," the health ministry said.

The pandemic has already killed 1.7 million people around
the world, sown chaos through the global economy and upended
normal life for billions since it began in Wuhan, China, a year
ago.

Britain and South Africa in particular are grappling with
new variants of the coronavirus, which the government and
scientists say are more contagious; many countries have
responded by banning passenger flights and blocking trade.

AstraZeneca and other developers have said they are studying
the impact of the new variant but expect that their shots will
be effective against it.

Regulatory endorsement is a welcome boost for AstraZeneca
and the Oxford team, which have been accused of a lack of
clarity about the results from late-stage trials.

Pooled results from those trials show it had overall
efficacy was 70.4%. Efficacy was 62% for trial participants
given two full doses, but 90% for a smaller sub-group given a
half, then a full dose.

Researchers said that the finding of 90% efficacy for the
low-dose/high-dose regime needed more investigation. AstraZeneca
did not specify which dose regime had been approved.

"Today is an important day for millions of people in the UK
who will get access to this new vaccine," AstraZeneca Chief
Executive Pascal Soriot said.

"It has been shown to be effective, well-tolerated, simple
to administer and is supplied by AstraZeneca at no profit."
(Reporting by Alistair Smout in London, additional reporting by
Pushkala Aripaka in Bengaluru; editing by Guy Faulconbridge)

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