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 Prime Minister Boris Johnson touted the medicine authority's
approval as a global win and a ray of hope amid the gloom of the
novel coronavirus which has killed nearly 1.5 million people
globally, hammered the world economy and upended normal life.
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, in record time -
just 23 days since Pfizer published the first data from its final
stage clinical trial.
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.
"It's fantastic," Johnson said. "The vaccine will begin to be made
available across the UK from next week. It's the protection of
vaccines that will ultimately allow us to reclaim our lives and get
the economy moving again."
The approval of a jab for use almost exactly 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.
But the breakneck speed at which approval was given drew criticism
from Brussels where, in an unusually blunt statement, the European
Union's drugs regulator said its longer procedure to approve
vaccines 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 jab
themselves, priority had to be given to those most in need - the
elderly, those in care homes and health workers.
'NO CORNERS CUT'
The U.S. drugmaker said Britain's emergency use authorization marks
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," she said. Asked if Britain's looming exit
from the European Union's orbit on Dec. 31 had any role, Raine said
the fast-tracked vaccine approval was done under European law.
"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.
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The U.S. Food and Drug Administration (FDA) 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 programme," said Ugur Sahin, chief executive and
co-founder of BioNTech.
Anti-poverty campaigners, meanwhile, warned against rich countries
hoarding the vaccine 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.
"Age is by far the single most important factor in terms of risk
from COVID-19," said Wei Shen Lim, head of Britain's COVID-19
vaccine committee. Lim said there had been no suggestion a vaccine
would be compulsory.
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.
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.
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, from up to 15 days previously guided. 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 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.
(Reporting by Guy Faulconbridge and Paul Sandle; Additional
reporting by Kate Kelland, Alistair Smout and Estelle Shirgon;
Editing by Kate Holton, Carmel Crimmins and Alex Richardson)
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