By Max Colchester, Jenny Strasburg and Daniel Michaels
The U.K.'s vaccines advisory body said the Covid-19 vaccine
produced by AstraZeneca PLC should preferably not be given to
people under 30 following concerns that it causes potentially
deadly blood clots in very rare instances.
The decision Wednesday to restrict the vaccine for younger
people is a setback for the U.K.'s flagship inoculation drive and
leaves the country increasingly dependent on Covid-19 shots
developed and produced in other countries.
It also lands another blow on the vaccine developed by
AstraZeneca and the University of Oxford, which have faced
questions about its efficacy and potential side effects even as
tens of millions of doses have been administered following safety
signoffs in more than 70 countries world-wide.
The vaccine, which unlike others doesn't need to be stored at
super-cold temperatures, has been regarded as critical to the
vaccine rollout in poorer countries, many with relatively young
populations.
The speed of the U.K.'s fast-paced vaccine program shouldn't be
affected by the decision as long as vaccine supplies hold up,
British officials said. "It is a course-correction, if you like, to
the U.K. program," said U.K. deputy chief medical officer Jonathan
Van-Tam.
British Prime Minister Boris Johnson said that he didn't see
"any reason at this stage" to alter the country's plan to gradually
reopen the economy over summer. He added he was confident about the
country's vaccine supply.
Also Wednesday, the European Union's health agency said it had
found possible links between the AstraZeneca vaccine and rare blood
clots but that the shot's benefits continue to outweigh the
potential risks. The European Medicines Agency said it found no
specific risk factors linking the vaccine to the clots.
A number of EU countries, including France, Germany and Italy,
have resumed AstraZeneca vaccinations after temporarily suspending
their use last month following reports that people who had received
the AstraZeneca shot developed rare blood clots and that some had
died, further slowing Europe's vaccination rollout. But last week,
Germany's government said it would restrict use of the vaccine for
people younger than 60.
Canadian authorities have also urged a halt in use of the
Oxford-AstraZeneca vaccine in people under the age of 55, a sharp
shift from officials' earlier view that the vaccine was safe for
all ages.
In the U.K., the government said last week that 79 severe
blood-clotting cases had been reported in the U.K. out of 20
million administered doses of the vaccine. Nineteen of the people
died, the regulator said Wednesday. The blood clotting is "a
vanishingly rare but sadly quite serious adverse event," said Dr.
Van-Tam.
The U.K. medicine regulator, the Medicines and Healthcare
products Regulatory Agency, estimated the risk of developing a clot
after vaccination is about four people in a million.
The regulator said more work is needed to establish the cause of
the clotting. Specialists say that blood clotting is common among
people with Covid-19 and that the clotting after vaccination may --
though they are unsure -- be related to a reaction of the immune
system.
AstraZeneca said the European and U.K. reviews "reaffirmed the
vaccine offers a high-level of protection against all severities of
Covid-19 and that these benefits continue to far outweigh the
risks." It's continuing to work with regulators to reflect the
recommended changes to information for vaccine recipients and
healthcare providers, and to study the rare blood-clotting events
and possible causes.
The incidence of blood clotting after vaccination has been
proportionately higher among younger people than in older age
groups, Dr. Van Tam said. Given that younger people are less likely
to die of Covid-19 than older people, Britain's Joint Committee on
Vaccination and Immunization said it would be preferable if those
under 30 received alternative vaccines.
The U.K. decision also reflects progress in bringing down
Covid-19 caseloads after months of lockdown. In much of Europe, by
contrast, cases are increasing. France last week announced a new
national lockdown and German Chancellor Angela Merkel has urged
regional authorities to take tougher measures to control
infections.
Dr. Van-Tam presented analysis by the University of Cambridge
showing that for someone age 20 to 29 years, the benefits of
vaccination in preventing illness severe enough to need intensive
care would easily outweigh the improbable risk of suffering a blood
clot if Covid-19 was spreading as quickly as it was in Britain in
February -- and even more so if cases were proliferating as fast as
they were late last year.
But that calculus changes when case numbers dwindle to the level
they have reached recently. The analysis showed that if daily cases
numbered two per 10,000 people, as they did in March, vaccination
would prevent 0.8 intensive-care admissions among 100,000
20-to-29-year-olds. That compares with a risk of around 1.1 in
100,000 for developing a blood clot after vaccination.
The U.K. authorities have taken a number of calculated risks as
they raced to immunize the population against Covid-19. Britain's
medicines regulator was the first in the world to sign off on the
vaccine. The government also took the controversial decision to
delay giving second vaccine doses by up to 12 weeks to allow more
people to be inoculated with a first dose.
Currently, Britain has vaccinated a larger share of its
population than any other major Western nation. Britain is planning
to give all adults who want it a vaccine dose by the end of July,
allowing it to reopen its economy faster than other European
nations. Some 31.7 million people have received a first vaccine
dose and 5.7 million a second.
Much of this is predicated on the AstraZeneca vaccine. Britain
has secured access to seven different Covid-19 vaccines and over
350 million doses. So far, most people have received the
AstraZeneca shot.
Health regulators now recommend that those under 30 receive the
shots developed jointly by Pfizer Inc. and BioNTech SE and by
Moderna Inc. The first inoculations of the Moderna vaccine began
this week in the U.K.
On Wednesday, officials from the European regulator said that
most clots that have been identified were in people under age 60
and women but cautioned that the data didn't pinpoint a link
because it remained unclear how representative recipients of the
AstraZeneca vaccine are within the overall population.
EMA Executive Director Emer Cooke said that because the clots
are so rare, the risk of death from Covid-19 is much greater than
the risk of dying from the possible side effects.
Asked at a press conference why the EMA hadn't recommended
limiting use of the AstraZeneca vaccine to specific populations, as
the U.K. and other countries have done, Ms. Cooke said that
information on the cases reviewed by the EMA didn't indicate "any
causal link between the different gender or age groups."
Ms. Cooke said that the AstraZeneca vaccine is being given more
widely to younger age groups in the U.K. than in parts of the EU,
and the EMA will consider the issue in its continuing
evaluations.
AstraZeneca's vaccine rollout has been tarnished by a series of
stumbles.
They have included communications mishaps with U.S. regulators
and confusing results from large-scale trials and delivery problems
in the EU that has brought ongoing political criticism.
Last month, AstraZeneca found itself in a public spat with U.S.
officials over the precise results of a big U.S. clinical trial of
the vaccine. The company's handling of trial results upset
regulators and chipped away at the drugmaker's reputation in its
biggest market. AstraZeneca has said it would ask U.S. officials to
consider the vaccine for use in the U.S.
Jason Douglas contributed to this article
Write to Max Colchester at max.colchester@wsj.com, Jenny
Strasburg at jenny.strasburg@wsj.com and Daniel Michaels at
daniel.michaels@wsj.com
(END) Dow Jones Newswires
April 07, 2021 14:38 ET (18:38 GMT)
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