By Bojan Pancevski, Jenny Strasburg and Jared S. Hopkins
LONDON -- The U.K. became the first Western nation to grant
emergency-use authorization for a Covid-19 vaccine, clearing a shot
developed by Pfizer Inc. of the U.S. and BioNTech SE of Germany to
be distributed in limited numbers within days.
The two-shot vaccine is also being reviewed by the Food and Drug
Administration in the U.S., where a similar authorization could
come later this month and a rollout before the end of the year.
The U.K. green light on Wednesday punctuates a monthslong sprint
by the two drugmakers, which teamed up earlier this year and then
pulled ahead of two other Western pharmaceutical giants, each with
its own promising shot. Vaccines typically take years to bring to
It also marks a key milestone in efforts to translate a
promising new vaccine technology into a widely available shot. It
was developed, tested, authorized and is now poised to be
distributed amid a pandemic that has sickened tens of millions of
people and killed more than 1.4 million around the world.
The U.K. has ordered 40 million doses, enough to vaccinate 20
million people. Health Secretary Matt Hancock said Wednesday the
country is expecting an initial 800,000 doses to arrive in Britain
next week. He said the speed at which vaccinations will take place
will depend on how quickly the shot can be manufactured at a plant
in Belgium, but the government is expecting "many millions" of
doses by the end of the year.
"This will start small and ramp up. The vast majority of
vaccinations we expect to be in the New Year," Mr. Hancock said in
an interview with the British Broadcasting Corp.
People familiar with the matter said the U.K. might get four
million to five million doses this year, but the number is in flux
and will depend on production and other potential regulatory
authorizations. The U.K. said it planned to use that limited supply
to start vaccinating nursing-home residents and staff, and then
move on to other highly vulnerable groups.
That sets up the U.K. as a potential test case for how
distribution -- and uptake -- of the vaccine might unfold in other
countries. The National Health Service, Britain's state-funded
health system, runs hospitals across the country, and has been
tapped to distribute the shots. The U.K. has also long been a
battleground for vaccine skeptics, setting up a potential challenge
here for the government: persuading people to get the shot.
A panel of experts advising the Food and Drug Administration is
planning to review the vaccine on Dec. 10. The FDA could authorize
soon after, and supplies should become available not long after
that. Pfizer has already started shipping shots to distribution
Pfizer and BioNTech joined forces at the onset of the virus
outbreak and edged ahead of two other promising vaccine candidates,
one from Moderna Inc. and the other developed by the University of
Oxford and AstraZeneca PLC.
Moderna's vaccine is being reviewed by the FDA as well and could
be authorized for distribution in limited quantities in the U.S. by
the end of the year. China and Russia have been vaccinating their
populations with homegrown vaccines, too. The U.S., Europe and
several other developed countries have held out hope for one or all
of the three leading Western shots.
Results of clinical trials for each, disclosed over recent
months, have raised hope that governments can quickly start
inoculating their populations to build widespread immunity and
begin to more confidently reopen businesses, schools and tourist
destinations that have been closed, opened and then closed again
amid the ebb and flow of the virus. When Pfizer and BioNTech first
disclosed early, promising results, global stock markets shot
Pfizer said last month that trials found its vaccine to be 95%
effective in preventing symptomatic Covid-19. Moderna days later
said its vaccine, developed with the same genetic technology upon
which the Pfizer vaccine is based, showed efficacy of 94.5%.
Both vaccines use a new technology, leveraging mRNA, short for
the molecular couriers called messenger RNA that carry genetic
instructions to cells. The shots deliver mRNA that prompts cells to
make a synthetic version of the spike protein that juts from the
surface of the new coronavirus. That protein triggers the immune
system to defend against the virus.
The shot developed by Oxford and AstraZeneca works like a more
traditional vaccine, introducing a weakened virus, in this case one
found in chimpanzees, into the body to trigger immunity. It showed
an efficacy range of 62% to 90%, depending on the dosage.
The U.K. has ordered its medicines regulator to review that
vaccine for emergency use, too. AstraZeneca is still conducting
trials in the U.S. and is expected to submit its vaccine to the FDA
once it has enough data.
The European Medicines Agency, the top medical regulator for the
European Union, has said it hopes to authorize at least one of the
three vaccines by the end of the year.
Russia, which was criticized in the West over the speed of
development, has claimed its vaccine has efficacy of more than 90%.
Chinese developers haven't provided data from the final clinical
trials of their shots.
The U.K.'s emergence as the first Western country to get a
vaccine is the result of fast work by the country's Medicines and
Healthcare products Regulatory Agency. Britain is transitioning out
of the EU, with the exit fully kicking in Jan. 1. As a member of
the bloc, authorization of the U.K.'s new drugs were in the past
overseen by the EMA, which had been based in London until Brexit
prompted it to move to Amsterdam.
The MHRA in the past worked in close partnership with the EMA,
handling a significant portion of the Europe-wide portfolio of
medicines and medical devices awaiting authorization. As such, its
staff of 1,320 is experienced in the kind of safety scrutiny the
vaccines have attracted.
Brexit has meant the work the MHRA did for all of Europe was
reduced significantly, freeing up knowledgeable staff to move
quickly when vaccine data became available, according to
researchers familiar with the agency.
While drug authorization for British citizens is still in most
cases in the hands of the EMA until the end of the year, the U.K.
government used a long-held power to authorize a drug for emergency
use, after the MHRA signed off on its safety.
People who have worked with the U.K. agency in recent months say
it has been more proactive in cooperating with drug companies as
they provide data, asking additional questions and requesting more
information that could speed a review. Like the FDA and the EMA,
the U.K. regulator has received data on a rolling basis. Recently,
the MHRA's rolling review has been a "much more interactive
experience," said Sarah Blagden, associate professor of
experimental cancer therapeutics at the University of Oxford, who
oversees cancer trials. "The regulators become part of the
discussion very, very early on," she added.
June Raine, head of the MHRA, said the agency followed
international standards for reviewing vaccines, starting in June
with the setting of effectiveness hurdles and carrying through to
the testing of manufactured doses for quality in recent days. Asked
during a press briefing about public concerns that the regulator
rushed the process, Dr. Raine said, "Everyone can be absolutely
confident that no corners whatsoever have been cut."
The U.K. government has been among the world's most proactive in
buying vaccines. It has now secured access to roughly 357 million
doses from seven manufacturers. Given the current vaccines are
expected to require two shots, that is enough to vaccinate the
population 2.7 times over, providing some leeway if not all
vaccines come to fruition.
The rapid authorization could provide a political boost to Prime
Minister Boris Johnson, whose handling of the pandemic so far has
been criticized from both sides of the political spectrum in the
U.K. From his own party, lawmakers have argued his lockdowns have
been too strict, while opposition parties say he was too slow to
appreciate the threat of the coronavirus when it emerged. They
point to expensive programs, such as a countrywide test-and-trace
system, that have struggled to make an impact on infection
The U.K. has suffered the fourth-highest death rate of the major
European countries -- after Belgium, Spain and Italy -- and its
economic performance has been among the weakest in the region this
year. This week, a second national lockdown across England is set
to end as new Covid-19 cases fall across most of the country and
related deaths start to level off. England will then enter into a
phase of regional restrictions, with curbs on hospitality
businesses across much of the country.
Mr. Johnson's battle against Covid-19 has also been personal. In
April, he was hospitalized in an intensive-care unit and received
oxygen after testing positive and showing symptoms of the
--Jason Douglas contributed to this article.
Write to Bojan Pancevski at firstname.lastname@example.org, Jenny
Strasburg at email@example.com and Jared S. Hopkins at
(END) Dow Jones Newswires
December 02, 2020 07:39 ET (12:39 GMT)
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