* UK first in the world to approve Pfizer-BioNTech vaccine
* Vaccine roll out from early next week
* Shots 'will allow us to reclaim our lives', says PM
Johnson
* Medicine regulator approves vaccine in record time
* EU watchdog urges longer approval process
(Adds Johnson and German ambassador)
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 greenlight from the
UK's medicine authority as a global win and a ray of hope amid a
pandemic, though he recognised the logistical challenges of
vaccinating an entire country of 67 million.
Britain's move raised hopes that tide could soon turn
against a virus which has killed nearly 1.5 million people,
hammered the world economy and upended normal life for billions.
Britain's Medicines and Healthcare products Regulatory
Agency (MHRA) granted emergency use approval to the
Pfizer-BioNTech vaccine, which they say is 95% effective in
preventing illness, just 23 days since Pfizer published the
first data from its final stage clinical trial.
"Fantastic news," Johnson told parliament, though he
cautioned that people should not get too 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 to begin the long road to recovery, and getting there
first may be seen as a coup for Johnson's government, which has
faced criticism over its handling of the crisis.
The approval of a shot for use close to a year since the
novel coronavirus emerged in Wuhan, China, is a triumph for
science, Pfizer boss Albert Bourla and his German biotechnology
partner BioNTech.
Both the United States and the European Union's regulator
are sifting through the same Pfizer vaccine trial data, but have
not yet given their approval.
Britain's breakneck speed drew criticism from Brussels
where, in an unusually blunt statement, the EU's drugs regulator
said its longer procedure was more appropriate as it was based
on more evidence and required more checks.
British leaders said that, while they would love to get a
shot themselves, priority had to be given to those most in need
- the elderly, those in care homes and health workers.
Amid the celebratory rhetoric, Germany's ambassador to
Britain Andreas Michaelis publicly scolded a British minister
for presenting it as a national triumph.
"I really don't think this is a national story. In spite of
the German company BioNTech having made a crucial contribution,
this is European and transatlantic," Michaelis said.
'NO CORNERS CUT'
The U.S. drugmaker said Britain's emergency use
authorization marked a historic moment in the fight against
COVID-19. Pfizer announced its vaccine breakthrough on Nov. 9
with stage III clinical trial results.
"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 Bourla.
Britain's medicines regulator 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."
"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.
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 advisors meets
on Dec. 10 to discuss whether to recommend it. 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.
"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 a decision in
mid-December.
Anti-poverty campaigners, meanwhile, warned against rich
countries hoarding vaccines at the expense of poorer ones. "The
worst thing we can do at this moment is allow a small number of
countries to monopolise access to vaccines like this," said
Romilly Greenhill, UK director of the ONE organisation.
FIRST IN LINE?
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.
"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.
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.
Health Secretary Matt 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 storage at temperature typical of an Antarctic winter.
Pfizer has said the shots can be kept in thermal shipping
boxes for up to 30 days. Afterwards, the vaccine can be kept at
fridge temperatures for up to five days.
Other frontrunners in the vaccine race include U.S. biotech
firm Moderna, which has said its shot was 94% successful in
late-stage clinical trials, and AstraZeneca, which said
last month its COVID-19 shot was 70% effective in pivotal trials
and could be up to 90% effective.
(Reporting by Guy Faulconbridge and Paul Sandle; Additional
reporting by Kate Kelland, Alistair Smout and Estelle Shirgon;
Editing by Kate Holton, Carmel Crimmins, Alex Richardson and
Nick Macfie)
Astrazeneca (AZN)
