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UPDATE 4-UK approves Pfizer-BioNTech COVID-19 vaccine, first in the world

Wed, 02nd Dec 2020 07:08

* UK is first in the world to approve Pfizer-BioNTech
vaccine

* Vaccine roll out from early next week

* 'Very good news' - health secretary
(Adds number of doses the UK has ordered, additional quotes)

By Guy Faulconbridge and Paul Sandle

LONDON, Dec 2 (Reuters) - Britain on Wednesday became the
first western country to approve a COVID-19 vaccine, jumping
ahead of the United States and Europe after its regulator
cleared a shot developed by Pfizer for emergency use in
record time.

The vaccine will be rolled out from early next week in a
major coup for Prime Minister Boris Johnson's government, which
has faced criticism over its handling of the coronavirus crisis
with Britain enduring the worst official COVID-19 death toll in
Europe.

A vaccine is seen as the best chance for the world to get
back to some semblance of normality amid a pandemic which has
killed nearly 1.5 million people and upended the global economy.

"The government has today accepted the recommendation from
the independent Medicines and Healthcare products Regulatory
Agency (MHRA) to approve Pfizer-BioNTech's COVID-19 vaccine for
use," the government said.

Britain touted the approval as a global win and a ray of
good hope amid the gloom as big powers race to approve an array
of vaccines and inoculate their citizens.

"I'm obviously absolutely thrilled with the news, very proud
that the UK is the first place in the world to have a clinically
authorised vaccine," British Health Secretary Matt Hancock said.

China has already given emergency approval for three
experimental vaccines and has inoculated around 1 million people
since July. Russia has been vaccinating frontline workers after
approving its Sputnik V shot in August before it had completed
late-stage testing on safety and efficacy.

'HISTORIC MOMENT'

Pfizer and its German partner BioNTech have said
their vaccine is 95% effective in preventing illness, much
higher than expected.

The U.S. drugmaker said Britain's emergency use
authorization marks a historic moment in the fight against
COVID-19.

"This authorization is a goal we have been working toward
since we first declared that science will win, and we applaud
the MHRA for their ability to conduct a careful assessment and
take timely action to help protect the people of the UK," said
CEO Albert Bourla.

"As we anticipate further authorizations and approvals, we
are focused on moving with the same level of urgency to safely
supply a high-quality vaccine around the world."

Britain's medicines regulator approved the vaccine in record
time. Its U.S. counterpart is set to meet on Dec. 10 to discuss
whether to recommend emergency use authorization of the
Pfizer/BioNTech vaccine and the European Medicines Agency said
it could give emergency approval for the shot by Dec. 29.

"The data submitted to regulatory agencies around the world
are the result of a scientifically rigorous and highly ethical
research and development program," said Ugur Sahin, chief
executive and co-founder of BioNTech.

FIRST IN LINE?

Britain's vaccine committee will decide which priority
groups will get the jab first: care home residents, health and
care staff, the elderly and people who are clinically extremely
vulnerable will be first in line.

Hancock said hospitals were ready to receive the shots and
vaccination centres would be set up across the country but he
admitted distribution would be a challenge given that the
vaccine must be shipped and stored at -70C, the sort of
temperature typical of an Antarctic winter.

Pfizer has said it can be stored for up to five days at
standard refrigerator temperatures, or for up to 15 days in a
thermal shipping box.

Johnson said last month that Britain had ordered 40 million
doses of the Pfizer vaccine - enough for just under a third of
the population as two shots of the jab are needed per person to
gain immunity.

Other frontrunners in the vaccine race include U.S. biotech
firm Moderna, which has said its shot is 94% successful in
late-stage clinical trials. Moderna and Pfizer have developed
their shots using new messenger RNA (mRNA) technology.

AstraZeneca said last month its COVID-19 shot, which
is based on traditional vaccine technology, was 70% effective in
pivotal trials and could be up to 90% effective.
(Editing by Kate Holton and Carmel Crimmins)

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