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* UK first in the world to approve Pfizer-BioNTech vaccine
* Vaccine roll out from early next week
* 'Fantastic news', says PM Johnson
* Medicine regulator approves vaccine in record time
* EU watchdog urges longer approval process
(Adds WHO comment, U.S. Health Secretary comment)
By Guy Faulconbridge and Paul Sandle
LONDON, Dec 2 (Reuters) - Britain approved Pfizer's
COVID-19 vaccine on Wednesday, jumping ahead of the rest of the
world in the race to begin the most crucial mass inoculation
programme in history with a shot tested in wide-scale clinical
trials.
Prime Minister Boris Johnson touted the green light from
Britain's medicine authority as a global win and a ray of hope
amid the pandemic, though he recognised the logistical
challenges of vaccinating an entire country of 67 million.
Britain's move raised hopes that the tide could soon turn
against a virus that has killed nearly 1.5 million people
globally, hammered the world economy and upended normal life for
billions since it emerged in Wuhan, China, a year ago.
Britain's Medicines and Healthcare products Regulatory
Agency (MHRA) granted emergency use approval to the vaccine
developed by Pfizer and German biotechnology partner BioNTech
, which they say is 95% effective in preventing illness,
just 23 days after Pfizer published the first data from its
final stage clinical trial.
"Fantastic news," Johnson told parliament, though he
cautioned that people should not get carried away.
"At this stage it is very, very important that people do not
get their hopes up too soon about the speed with which we will
be able to roll out this vaccine."
The world's big powers have been racing for a vaccine for
months and coming first may be seen as a coup for a government
that has faced criticism over its handling of the crisis.
Both the U.S. and EU regulators are sifting through the same
Pfizer vaccine trial data, but have yet to give their approval.
Britain's speed drew criticism from Brussels where, in an
unusually blunt statement, the EU regulator said its longer
procedure was more appropriate as it was based on more evidence.
Johnson might be persuaded to take a COVID-19 jab on
television to show it was safe, but he would not have one before
those in greater need, his press secretary said.
Just hours after the British announcement, President
Vladimir Putin ordered Russian authorities to begin mass
voluntary vaccinations next week. Russia will have produced 2
million does of its own vaccine within the next few days, Putin
said.
Pfizer vaccine executive Ralf Rene Reinert said other
countries were looking to emulate Britain.
"I wouldn't make this a race between countries," he said.
"The UK is leading, and now let's see how the other countries
move forward. And Pfizer will do everything to exchange all the
data packages with every regulatory agency."
German Health Minister Jens Spahn said EU member states
could have issued similar emergency approvals but Europe had
decided to move forward as one.
"It's very important we do this to help promote trust and
confidence in this authorisation," he said.
'NO CORNERS CUT'
Britain's MHRA approved the vaccine in record time by doing
a "rolling" concurrent analysis of data and the manufacturing
process while Pfizer raced to conclude trials.
"No corners have been cut," MHRA chief June Raine said in a
televised briefing from Downing Street, adding that the first
data on the vaccine had been received in June and undergone a
rigorous analysis to international standards. "Safety is our
watchword."
The emergency use approval does not come with any associated
volume cap or threshold, Pfizer UK's country manager said.
"With 450 people dying of COVID-19 infection every day in
the UK, the benefits of rapid vaccine approval outweigh the
potential risks," said Andrew Hill, senior visiting research
fellow in the Department of Pharmacology at the University of
Liverpool.
U.S. Health Secretary Alex Azar said that the British move
should inspire confidence.
"For the American people this should be very reassuring: an
independent regulatory authority in another country has found
this vaccine to be safe and effective for use," Azar told Fox
Business Network.
The U.S. Food and Drug Administration (FDA) will make a
decision on emergency use authorization on the Pfizer/BioNTech
vaccine in days or weeks after a panel of outside advisers meets
on Dec. 10. The FDA often but not always follows the panel's
advice.
The European Medicines Agency (EMA) said it could give
emergency approval for the shot by Dec. 29, while the World
Health Organization said it was reviewing it for "possible
listing for emergency use".
"The data submitted to regulatory agencies around the world
are the result of a scientifically rigorous and highly ethical
research and development programme," said Ugur Sahin, chief
executive and co-founder of BioNTech.
BioNTech said it expected FDA and EMA to make decisions in
mid-December.
Britain said it would start vaccinating those most at risk
of dying early next week after it gets 800,000 doses from
Pfizer's manufacturing centre in Belgium, and UK Health
Secretary Matt Hancock said tests on that first batch had been
completed.
"I strongly urge people to take up the vaccine but it is no
part of our culture or our ambition in this country to make
vaccines mandatory," Johnson said.
The speed of the rollout depends on how fast Pfizer can
manufacture and deliver the vaccine - and the extreme
temperature of -70C (-94F) at which the vaccine must be stored.
It can be kept for five days in a regular fridge.
Britain has ordered 40 million doses of the Pfizer vaccine -
enough for just under a third of the population as two shots are
needed per person to gain immunity.
(Reporting by Guy Faulconbridge and Paul Sandle; Additional
reporting by Kate Kelland, Alistair Smout, Estelle Shirbon,
William James, Thomas Escritt, Stephanie Nebehay, Susan Heavey
and Francesco Guarascio; Editing by Kate Holton, Carmel
Crimmins, Alex Richardson and Nick Macfie)
